IA #89-04 - 8/2/01, "DETENTION WITHOUT PHYSICAL EXAMINATION OF DEVICES THAT
HAVE NOT MET DEVICE GMP'S", Attachment 3/11/09
SUBJECT: DETENTION WITHOUT PHYSICAL EXAMINATION OF DEVICES THAT HAVE NOT
MET DEVICE GMP'S
NOTE: This revision is being issued to revise the alert into the current
format and terminology. Changes are bracketed by asterisks (***).
TYPE OF
ALERT: *** Detention Without Physical Examination (DWPE) ***
*** (Note: This import alert represents the Agency's current
guidance to FDA field personnel regarding the
manufacturer(s) and/or products(s) at issue. It does not
create or confer any rights for or on any person, and does
not operate to bind FDA or the public). ***
PRODUCT: All medical devices
PRODUCT
CODE: See attachment
PROBLEM: Deviations from Good Manufacturing Practices (GMPs)
PAF: PER (Performance)
PAC FOR
COLLECTION: 82008
COUNTRY: See attachment
MANUFACTURER
FEI#: See attachment
IMPORTER'S
ID#: N/A
***
CHARGE: "The article is subject to refusal of admission pursuant to
Section 801(a)(1) in that the methods used in, and the
facilities or controls used for, the manufacture of the
device do not conform to the requirements of Section
520(f)(1) or a condition prescribed by an order under
section 520(f)(2) [Adulteration, Section 501(h)]." ***
***
OASIS CHARGE
CODE: DEVICEGMPS ***
RECOMMENDING
OFFICE: CDRH, Office of Compliance (HFZ-323)
REASON FOR
ALERT: Foreign inspections of device manufacturers continue to be
conducted. FDA will not allow entry of affected products if
inspection reveals the manufacturer is not currently
operating in accordance with the device Good Manufacturing
Practices (GMP's). *** When inspection reveals that
corrections have been made, the recommendation to detain the
respective firm's devices without physical examination can
be withdrawn. ***
***
GUIDANCE: Districts may detain without physical examination the
devices from the firms identified on the attachment to this
alert.
For questions or issues concerning science, science policy,
sample collection, analysis, preparation, or analytical
methodology, contact the Division of Field Science at (301)
827-7605. ***
PRIORITIZATION
GUIDANCE: N/A
FOI: No purging required
KEYWORDS: Device GMPs, Good Manufacturing Practices, human use
devices, GMPs
PREPARED
BY: Ted Poplawski, DIOP, (301) 443-6553
DATE LOADED
INTO FIARS: August 2, 2001
ATTACHMENT TO IA #89-04 Revised 3/11/09
FIRMS/PRODUCTS RECOMMENDED FOR DWPE
ARGENTINA
FIRM PRODUCT
Cidal S.A. Latex Condoms
A.V. Freyre 1635 12/27/94
3000 Santa Fe,
Argentina
MID #ARCIDSA1635SAN
Unimed Embolectomy Catheter:
Calle 97, No 2156 Felix Ballister (11/5/93)
San Martin, Argentina 1650 Classification Name-Catheter, Embolectomy;
MID# ARUNI2156SAN Classification Number - 74DXE, Class II
Regulation Citation-21CFR 870.5150
Biliary Catheter:
Classification Name; Catheter, Biliary;
Classification Number-78FGE; Class II;
Regulation Citation-21 CFR 876.5010
Pleural Drain:
Classification Name; Catheter, Continuous Irrigation
Classification Number-79GBQ; Class II
Regulation Citation-21 CFR 878.4200
AUSTRALIA (AU)
FIRM PRODUCT
Cigweld Manual Resuscitator/73BTM
formerly: Comweld Group Pty, Ltd. 9/25/98
85 Chifley Drive
Preston, Victoria, Australia, 3072
FEI# 1000002652
Telectronics Pty. Ltd. All Devices Except:
7 Sirius Road Implantable Cardioverter
Lane Cove, NSW 2066 Defibrillators
Sydney, Australia Models 4211, 4215, & 4310
MID# AUTELPTY2LAN Product Code: 74LWS
Revised Product information - 7/17/95
Parts used in model 9600 network programmer printed circuit boards:
a. 9600 Main PCB (Part 110232)
b. 9600 ECG PCB (Part 1103238)
c. LCD Driver PCB (Part 1107704)
d. Telemetry PCB (Part 110324)
e. Keyboard PCB (Part 1103242)
f. Power Supply PCB (Part 1103240)
Parts used in Model 4510 implant support devices printed circuit boards:
a. 4510 Digital PCB (Part 1105769)
b. 4510 Analog PCB (Part 1103893)
Revised Product Information 5/6/96
BELGIUM
FIRM PRODUCT
Belgium Hospital Services Sterile Blood tubing sets
Boomsesteenweg 939 (9/11/92)
B-2610 Wilrijk, Belgium
BRAZIL
FIRM PRODUCT
Laboratories B. Braun S.A. Sterile Intravascular Administration
Av. Eugenio Borges, 1092 Sets and all other devices labeled
Arsenal-Sao Goncalo as sterile
Rio De Janeiro, Brazil
CANADA
FIRM PRODUCT
A.R. Medicom (Canada) Powdered, Vinyl Patient Examination
aka AMD Ritmed Gloves
9404 Corte De Liesse 80LYZ
Lachine, Quebec, Canada 7/13/01
H8T 1A1
FEI# 3002677549
Activa Brand Products, Inc. Vial Adapters for Needle-Free
36 Fourth Street Injectors
Charlottetown, 80KZE
Prince Edward Island, Canada 8/15/07
FEI# 1000228839
Benson Medical Industries, Inc. Product code: DE
151 Esna Park Drive (sterile devices only)
Markham, Ontario, Canada
Biosig Instruments, Inc. Intra-pulse Heart Rate Monitor, 105,
440- 19th Ave., Suite 100 107,201,302,303; Telepulse (T.M.)
Lachine, Quebec Radio
Canada, H8S3S Telemetry Heart Rate Monitor
MID #XQBIOINS440LAC Model 803;
Antache (R) Anti-Headache Device
(EMG Biofeedback System); Atense )
Anti-tension Device (EMG Biofeedback
System) Model 701 (8/5/93)
Canix Sterilizers* All Devices
7085 Tomken Road 7/5/00
Mississauga, Ontario
Canada L5S 1R7
FEI #3002954276
*The following firms may have had products processed by Canix Sterilizers
within the past two years. Entry documentation for devices shipped by these
firms should be reviewed to determine if they have been sterilized by Canix
Sterilizers and therefore may be subject to detention without physical
examination.*
Aiken Enterprises* Shemberg Corporation*
Four Winds Way 49 Belinda Square
Mississauga, ON, Canada L5R 3M4 Scarborough, ON, Canada M1W3M1
FEI# 3003052030 FEI# 1000476428
GMP, Inc* Starplex Scientific*
Invicta Drive 50 Steinway Boulevard
Oakville, ON, Canada L6H2K9 Etobicoke, ON, Canada M9W6Y3
FEI# 3001004242 FEI# 3002808074
National Home Products* Tube-Fab Ltd*
188 Limestone Cres. Machine Products Division
Downsview, ON, Canada M32S4 36 Fourth Street
FEI# 1000328564 Charlottetown, PE, Canada C1E2B3
FEI# 3002649711
Cyex Medical Techologies All Medical Devices Labeled
Inc. (CMTI) Sterile Device Class II
91 Kelfield Road, Unit 5 5/15/96
Rexdale, Ontario, Canada
M9W5A3
FEI# 1000256339
Garaventa (Canada) Ltd. Stair Trac - 12/15/98
7505 - 13A Street Product Code: 89IMK
Surrey, Canada Stair Porter
BC V3W 7B3 Product Code: 89IMK
FEI# 3001596273 Evacu-Trac
Product Code: 89IMK
Hedy Canada Latex Examination Gloves
#R1350 42nd Avenue, SE (Non-Sterile)/80LYY & 80FMC
Calgary, Alberta 7/1/97
T2G4V6 Canada
FEI# 3002807150
Med*Ex Diagnostics of Canada Inc. All devices
51 Leeder Avenue (01/06/93)
Coquitlam, British Columbia
Canada V3K 3V5
Moving people.net Canada, Inc. Power Scooter, 89INI:
500 Norfinch Drive Fortress Models 1700,
Toronto 1704, 2000 and 2001.
Ontario, Canada M3N 1Y4 Corsaire Power Chair
FEI #300313528789INO 9/25/02
Ophthalmic Technologies, Inc. OTI Scan 1000, OTI Scan 2000,
37 Kodiak Crescent, Unit 16 and OTI OCT/SLO Combination Imaging
Toronto, Ontario, Canada M3J3E5 System (Ophthalmoscope, Ac-powered)
FEI# 1000571171 Class II device
86HLI
2/8/08
Progressive Chemical All Devices/GPI=DE
Research, Ltd. (With the exception of
1410 40th Avenue, NE #20 the Alberta Lens S)
Calgary, Alberta 8/22/00
Canada T2E6L1
FEI# 3002934999
Ultrasoft Laboratories Contact Lenses (all types)
8855 Northbrook Court (2/9/93)
Burnaby, British Columbia, V5J 5G1
Canada
ID# XCULTLAB8855BUR
ID# XCULKTSOF4025BUR
Note: Ultrasoft Laboratories is also recommended for DWPE under Import Alert
#89-08.
CHINA, PROC
FIRM PRODUCT
Beijing Unisoft Contact Lens Soft Contact Lenses
Co. Ltd. 2/8/95
114 Xuanwumen Nei Street, 4th Fl.
Beijing, China 100031
MID #CNBEIUNI114BEI
HoMedics (China) All Devices*
Shi-Da Road, GPI=DE
Liang-Bian Industrial Zone 8/22/08
Liao-Bu Town, Dong Guan City 2/5/09 updated
GuanDong Province, China
FEI# 3004088065
*CDRH indicates Blood Pressure Monitors (74D-XN) and Electric Massagers (89I-
SA) are not subject to DWPE under this Import Alert.
Jiangyan Medical Products All Devices
Factory 6/9/97
Baogu, Jiangyan
Taizhou, Jiangsu, China 225521
FEI #3000306029
Kwonnie Electrical Products Limited Paraffin Baths
3rd Industrial Estate 89IMC
Qingxi Town Electric Toothbrushes
Dongguan Guangdong, China 76JEQ
FEI #3003516552 2/20/08
Nantong City Xin Kai Weaving All Devices
Factory 3/14/95
Zhao Yang Road
Nantong City, Jiangsu Province, China
MID# CNNANCITNAN
Ningbo Textiles All Devices manufactured
Import & Export Corp. by Textus Ningbo
188 South Jiefang Road GPI DE
Ningbo, China 10/25/01
FEI# 3003337763
Rossmax International Ltd. All Devices
aka Rossmax (Shanghai)Int'l. GPI=DE
aka Rossmax Medical 5/27/08
No. 6018 Huyi Road
Waigang, jiading
Shanghai, China
FEI# 3004003272
Shanghai Latex Factory All Latex Patient Powdered,
Changzheng Branch (Non-Sterile) Examination
251 Lannidu RO. Rudong and Surgeons Gloves
Shanghai, China 200120 (Sterile and Non-Sterile)
MID# CNSHALAT1700SHA 79KGO, 80FMC, 80LYY
FEI# 3332 1/25/96
MANUFACTURER
Teamedics (Taishan) Manufacturing Co. All Devices
aka Silkmate Manufacturing Co. Ltd GPI = DE
Hang Chen Industrial Area 2/27/08
Qian Jing Lu,
Xi Xiang Town, Zone #112
Shezhen, China
FEI# 3003800334
MANUFACTURER
Teamedics
Blk. 6/13 He Dong Industrial Village
Xin An Town, Bao An District
Shezhen, China
FEI# 3003156969
SHIPPER
Teamedics Manufacturing Co., Ltd.
(Hong Kong Office)
22/F., Block A, Corporation Park
11 On Lai Street, Siu Lek Yuen
Shatin, New Territories
Hong Kong
FEI# 3003846859
3002953797
Suzhou De Fa Medical All Devices
Dressing Factory 3/3/95
9-1 Inside Road South Gate
Suzhou City
Jiangsu Province, China
Textus Ningbo Manufacturing All Devices
Company Ltd. 8/4/00
Baidu Fenghua City
Zhejiang, China 315558
FEI #3002692542
Shippers:
Sinochem Ningbo Imp. & All Medical Devices Except
Export Co. Patient Examination Gloves
21 Jiang Xia St. 80LYY, 80LZA, 80LZC, 80LYZ, 80FMC
Ningbo, China 11/14/01
FEI #1000161568
Tong Zhou City Medical All Devices
Health Factory #2 3/3/95
Heng Gang Town East
Tong Zhou City
Jiangsu Province, China
Tong Zhou City Weaving Factory All Devices
Xing Ren Town 3/3/95
Tong Zhou City
Jiangsu Province, China
Xue Xia Health Products* All Medical Devices
Gaobu Town 3/3/95
Shaoxing, Zhejiang Province
China 312035
FEI #1000311839
DISTRIBUTORS
*Zhejiang Medicines & Health I/E Corp.
7 Tian Mu Shan Road
Hongzhou, China 310007
AND
*Zhejiang Medicines & Health Products I/E Corp.
Gaobu Town
Shaoxing, Zhejiang Province, China 312011
(MANUFACTURER)*
Zhang Jia Gang City Medical Cloth All Medical Devices
Factory #2 GPI-DE
Gaoqiao Houcheng Township 5/02/95
Zhang Jia Gang City
Jiangsu Province, China 215631
FEI: 1000340899
(DISTRIBUTOR -*for Zhang Jia Gang City)
Suzhou Du Fa Medical Dressing Factory All Medical Devices
No. 9-1, Inside Road South Gate from Zhang Jia Gang
Suzhou, Jiangsu Province, China City Medical Cloth
FEI: 1000340900 Factory #2
MID: CNSUZDU91SUZ 5/02/95
DENMARK
FIRM PRODUCT
Danplex A/S (Manufacturer) Diagnostic Audiometers
Sanderumvej 130 Product Code: 77EWO
Dk-5250 Odense SV Denmark Tympanometer
FEI #3002807987 Product Code: 77NAS
Danplex A/S (Sales, Administration)
Markaervej 2A
DK-2630 Taastrup Denmark
FEI #3002971999
Danpren Gloves AS* Gloves labeled Ahypoallergenic
15 Roholmsvej "dental gloves"
Albertslund, Denmark 2620 1/25/01
ID# DKDANGLO15ALB
Faaborg Rehab Technic Aps All Devices/GPI-DE
Smedemestervej 9 10/21/04
5600 Faaborg, Denmark
FEI #3004132708
Pinol Finmekank A/S Endosseous Dental Implants
Engvej 33 Product Code: 76DZE
DK-3330 Gorlose Denmark Counter Torque Key (accessory tool
FEI #3002807862 used for surgical implants)
Product Code: 76NDP
1/25/01
FRANCE
FIRM PRODUCT
Bio MS All Devices
Parc d'activities Pau Pyrenees (4/26/93)
64000 Pau, France
MID# FRBIOMSPAU
Kontron Instruments S.A. All Devices
2 Avenue Due Manet (6/25/92)
Motigny BP 81-F78185
St. Quentin, France
Laboratories Sebbin Breast Implants
62 Rue Saint Martin
95300 Pontoise, France
O.D.A.M. Defibrillators
19 Avenue De La Gare
Wissembourg F-67160
France
Poly Implant Prostheses, SA Saline Filled Breast Implants
337 Avenue De Bruxelles 79F--WM
La Seyne Sur Mer, France 10/28/05
FEI# 3002807918
St Gobain Ceramiques Zirconia Ceramic Femoral Head
Avancee Desmarquest Component/ 87/LZO
Rue de L'industrie ZI No. 1 7/9/02
27025 Evreux Cedex
France
FEI #3003302339
Telectronics Pacing Systems All Devices
11, Rue Andre Boulle 11/5/93
Chatellerault, France
MID# FRTELSA11CHA
MID# FRTELPAC11CHA
GERMANY
FIRM PRODUCT
Biodynamics International "Tutoplast Dura" (Dura Mater)
Industriestrasse 6 All models/lots, including 68006,
Neunkirchen am Brand, Germany 68007,68013,68065,68005,68001,
MID# DEBIOINT6NEU 68009,68004,68002,68111,68112.
5/5/94
OR
Biodynamics International (Deutchland) GmbH
Postfach 1243
D-91002 Erlangen, Germany
MID# DEBIOINT1243ERL
OR
Biodynamics International
Corporate Offices
Langmarckplatz
3, D-8520 Erlangen, Germany
MID# DEBIOINTERL
ESKA Implants GmbH & Co. All Devices
Grapengiesserstrasse 34 GPI=DE
Lubeck, Germany 6/30/06
FEI# 3002806932
Dewe and Company Sterile Bandages
Verbandstoff-Fabrik Dr. (8/29/94)
D-6532 Wermelskirchen, Germany
Ionto-Comed Ionto-Lift No.8223
Gmbh, Germany, Federal Rep. of (3/21/91)
MELA GMBH Elektromedizin All devices
Schatzbogen 38
Munich, Germany, Federal Rep. of
D-8000
Resorba Schonerstrasse 7 All devices for human use
8500 Nurnberg 70
Germany, Federal Rep. of
Serag-Wiessner GMBH All sterile devices for
Naila, Germany, Federal Rep. of veterinary use.
INDIA (IN, 455)
FIRM PRODUCT
RFB Latex Limited Sterile Latex Surgical &
24, Noida Export Processing Zone Examination Gloves/80LYY, 80FMC,
Noida Phase-II, Distt. Gautam Budh, 79KGO, 80LZA, 80LZC
Nagar, Noida, 201305, India 9/8/99
FEI #1000109446
INDONESIA (ID, 458)
FIRM PRODUCT
P.T. Gotong Rojong Djaja Patient Examination 80FMC &
33 Jalan Hindu Gloves 80LYY
Medan 20111 Indonesia CLASS I
FEI #1000509988 6/5/96
MID #IDPTGOT33MED
PT Krisna Mulia Nusantara Sterile disposable syringes
P.O. 1396 Product code: 80KZH
Pulogadung, Jakarta 13013, Indonesia 3/26/96
FEI# 1000386256
MID# IDPTKRI1396JAK
P.T. Saptindo Surgica Latex Surgical Gloves/79KGO
JL. Raya Serang KM. 65, 9/22/99
Cikande-Serang
Jawa Barat, Indonesia
FEI #3002794736
IRELAND
FIRM PRODUCT
Amicon Ireland, Ltd. Sterile Hemofilters and
Raheen Industrial Estate other Devices (EXCEPT In-Vitro
Limerick, Ireland Diagnostic Devices)
MID #IEAMIIRELIM 2/8/95
Virtus, Ltd. Trinity DVT System
Adamstown, Lucan Co. And Accessories/74J0W
Dublin 10/19/00
Ireland
FEI #300280454
ISRAEL
FIRM PRODUCT
Hi-Tec Implants Endosseous Implants 76DZE
5 Maskit St., (Smooth Fit Dental
Industrial Zone Implants) Class III
Herzlia, 46722 5/1/97
Israel
FEI #3000269166
ITALY
FIRM PRODUCT
Alfa Biotech, S.p.A. All devices
via Castagnetta 7 5/25/94
00040 Pomezia, Rome, Italy
MID# ITALFBIO7ROM
Bauer Surgical Instruments Temno Sterile
Via Zallone, 9 Biopsy Needles
40066 Pieve di Cento, Italy (10/26/93)
Diffuplast SRL Nutritional bags, parenteral
Via Piave 48 and enteral
Olgiate Olona, Italy 80K[][]PE/78K[][]NT
FEI# 3002806813 8/14/01
DKS Loversan S.p.A. Sterile Disposable Blood
Via XXV April, 79 Tubing Sets
21014 Laveno, Italy
Hatu - ICO S.P.A. All devices
Bologna, Italy
Micromeccanica Di Bianchi Lucia Hydroxyapatitic Endosseous
Via Petrarca, 17 (Dental Implants)/76DZE
Ceriano Laghetto (MI 8/24/99
Italy 20020
FEI #3002777665
Coating Firm:
Flametal, S.p.A.
Via G. Di Vittorio, No. 51
Fornovo Tara (Parma)
Italy
FEI #3002777667
Sclavo Diagnostica S.R.L.(Distributor) All devices
Rosia, Italy
MID# ITSCLDIAROS
Sclavo Diagnosticas, S.R.L. All devices
Via Fiorentino 1
Siena, 53100 Italy
MID# ITSCLINC1SIE
MID# ITSCLDIA1SIE
JAPAN
FIRM PRODUCT
Asahi Roentgen Industries X-Caliber EX-1000 and
Co., Ltd EX-2000 X-Ray Systems
376-3 Tsukiyama-cho, Kuze (Dental X-Ray)
Minami-ku, 601 Kyoto Product Code: 76EAP
Japan 8/24/95
MID# JAASAROE376KYO
Ishikawa Manufactory Co. Ltd. All devices
1647 Ohashi
Sano-Shi, Japan
Izumo Health Co., Ltd. Rubber Catheters,
6057 Nanaki Akashina-Machi non-sterile
Higshichi Koma-Gun (8/5/93)
Nagano, Japan
MID #JPIZUHEA6057NAG
Kawamoto Bandage Material All STERILE Medical
Company, Ltd. Devices
27, Itoyamachi, 2-Chome, Product Code: DE
Higashi-Ku 11/29/95
Osaka 540, Japan
MID# JPKAWBAN27HIG
FEI# 5900
Mackie 3M Specialties NEC Defibrillators
30-5 Yanagibashi 1-Chome (6/3/93)
Taito-Ku,Tokyo 111, Japan
ID# JPMAC3M305TAI
NEC Tochigi, Ltd. Defibrillators
484 Harigaya-Cho (6/3/93)
Utsunomiya City
Tochigi Pref., 321-01, Japan
ID# JPNECTOC484UTS
NEC San-Ei Instruments, Ltd. Defibrillators
1-57 Tecjin-Cho (6/3/93)
Kodaira City, Tokyo 187, Japan
ID# JPNECSAN157KOD
Olympus Optical Co., Ltd. All Sterile Devices
Odakura Nishigo-Mura (12/27/93)
Nishishirakawa-Gun
Fukushima, Japan
ID#JPOLYOPT5128INA
KOREA
FIRM PRODUCT
Boin Medica Co. Ltd. Disposable Syringes
293 Gong Dan-Dong (Sterile)
Gumi City, South Korea Product Code: 80FMF
SKMEDCOM293GUM Class: II
7/31/95
Dong Bang Medical Supplies Sterile Disposable
Corporation Syringes
5-27 Shin Kong Dok-Dong 3/21/96
Mapo-Ku, Seoul
Korea, Republic of
FEI #1000504733
MID #KRDONBAN527SE0
Orient Medical Supply Co., Ltd. Sterile Syringes
258-1 Youngwon - Ree Sterile Surgeon"s
Chongnam, Korea Gloves and Patient
(Manufacturing Site) Examination Gloves
Orient Medical Supply Co., Ltd. Sterile Syringes
Room 3403 Korean World Trade Center Sterile Surgeon"s
159 Sam Sung dong Gloves and Patient
Seoul, Korea Examination Gloves
Korea Trading International Sterile Syringes, Sterile Surgeon's
11th Floor Trade Tower gloves and Patient Examination
159 Samsung Dong, Kangnam-Ku Gloves that appear to be from Korea
Seoul, Korea Trading International may be from
Orient Medical Supply Co., Ltd.
Hesung Medical Supply Co., Ltd. All devices
517-4 Sangdaewon-Dong (7/27/92)
Seongnam City, Seoul, Korea
Sam Woo Corporation Ltd. Syrines, disposable & insulin
231-6 Kuk Jul-Ri (0.5-1.0 cc)
Kyunggi-Do Korea 80F[][]MF
FEI #3000251741 Disposable needles (14-27 gauge)
80F[][]MI
5/23/01
MALAYSIA
FIRM PRODUCT
Alang Bidara Industries Latex Patient Examination
Sdn Bhd, Lot 2574, Kampong Gloves
Olak Lempit, Kuala Langat 80LYY, 80FMC
42700 Banting, Selangor 9/4/96
Darul Ehsan, West Malaysia
FEI# 1000565458
MID# MYALABID2574KUA
Cranberry (M) Sdn. Bhd. Nitrile Patient Examination and
Lot 85, Jalan Portland Surgeons' Gloves
31400 Ipoh, Tasek Industrial Estate Product Codes: 80FMC
Malaysia 80LZC, 79KGO
FEI# 3368 1/6/00
Revised products now covered
8/3/05
MANUFACTURER
Dongkuk Techco Rubber All Devices
Industries, Sdn. Bhd. GPI=DE
Plot 31, Jalan 8, 3/11/09
Bakar Arang Industrial Estate,
08000 Sungai Petani,
Kedah Darul Aman, Malaysia
FEI# 6688
HEADQUARTERS
Dongkuk Techco Rubber
Industries, Sdn. Bhd.
7th Floor, Mayban Trust Bldg.,
3 Penang Street,
Penang 10200, Malaysia
FEI# 3002806836
SJ Medical Products SDN BHD Latex Exam Gloves
Lot 723, Batu 5 « 80LYY
Jalan Kapar 42100 2/10/99
Klang, Selangor, Dural Ehsan
Malaysia
FEI# 1000258938
Sime Healthcare Sdn. Bhd. All condoms
65-66 Senawang Industrial Estate Product codes: 85HIS, 85LTZ
Negeri Sembelan, Darul Khusus 11/21/95
70450 Seremban, Malaysia
FEI# 1000146238
MID# MYSIMHEA7045NEG
MEXICO
FIRM PRODUCT
Derivados De Gasa SA De CV All Devices Except:
Avenue Henry Ford No. 366 Non-Sterile Cotton/Gauze
Mexico City, Mexico DF 07850 Absorbable Material
FEI# 1000427130 PRODUCT CODE: 79KXX
ID# MXDERDE366MEX 5/7/96
Guantes Quirurgicos S.A. All Devices
de C.V. Av. Centenario No. 15 (3/9/94)
62500 Civac Jiutepec
Cuernavaca, Moreles, Mexico
Nellcor Puritan Bennett Mexico CapnoProbe SLS Sublingual CO2
S.A. de C.V., Tijuana B.C. Sensor
22570 Mexico 73CCK
FEI# 3002807391 4/6/05
Supertex Industrial SA de CV Examination gloves,
Carretera A Bosques de San latex
Isidro No. 1136 80LYY/80FMC
Zapopan, Jalisco, Mexico 1/25/99
FEI# 3001166250
Westmed de Mexico, S.A. *See list below*
Blvd. Encino #100, 73CBT, 73CAH, 73CAI, 73CAF,
Parque Industrial 73BTC, 73BZA, 73BTT,
Baja California 10/1/04
Tecate, Mexico
FEI# 3003949221
* Westmed Pulset Arterial Blood Gas Sampling Kits:
1. Pulset Syringes with Needles- (1cc): Part No.'s- 3103, 3103-98,
3105-95, 3105, 3105-99, 3173-14, 3173-95, 3173-98, 3173-99.
2. Pulset Syringes with Needles- (3cc): Part No.'s- 3302, 3302-95,
3302-98, 3302-99, 3303, 3303-95, 3303-98, 3303-99, 3300, 3372,
3372-95, 3372-98, 3373, 3373-95, 3373-98, 3373-99.
3. Pulset Syringes with Needles-(1cc-3cc): Part No.'s- 3100-25,
3100-20, 3100-30, 3300-21, 3300-25, 3300-30, 3500-25.
4. Pulset Syringes with Needles- (5cc)
5. MultiSampler Kits: Part No.'s- 3100-22, 3300-22.
6. Cord Gas Kits: Part No.'s- 3182, 3380.
Westmed Heat and Moisture Exchanger: Product No. 6216 (Clear
Bacterial/Viral Filter), Product No. 6218 (HME Filter, Angled Inlet, CO2
Port), Product No. 6229 (HME, Angled), and, 7-00-282 (Bacterial/Viral
Filter, Anesthesia/Respiratory, Bulk); and all products that contain filter
sub-part numbers: 0602-00, 0602-01, and 0602-02.
NETHERLANDS
FIRM PRODUCT
European Medical Contract Mfg.* ADCON-L
MiddenKamPweg 17 Anti-Adhesion Barrier/
6546 Nijmegen 89MLQ
Netherlands
FEI #3002806942
SHIPPER ADDRESSES*:
Gliatech Inc. E.M.C.M. Bv
Middenkampweg 17
Nijmegen, Netherlands
FEI# 3001717376
Gliatech
Gerstweg 2
Nijmegen, Netherlands
FEI# 3000147966
Orthoton BV T-Gear
Avelingenwest 27c (Orthodontic Head Gear)
Gorinchem, Netherlands 76DZB
FEI# 3002989352 7/19/04
PAKISTAN
FIRM PRODUCT
Alframed All Devices, GPI=DE
Roras Road, 72-C, S.I.E 6/8/05
Sailkot, Pakistan
FEI# 3002572819
Ess Zee Industries All Devices/GPI=DE
Roras Road 9/23/04
Sialkot, Pakistan
FEI #3003089395
Everbright Industries Inc All devices
PO Box 336 (including stainless steel
Sialkot, Pakistan surgical instruments)
ID# PKEVEIND336SIA 5/20/94
Garana Industries All Devices/GPI=DE
Po Gohadpur 9/24/02
Sialkot, Pakistan
FEI #3003759558
Gulmag International All devices
Sharif Pura, Mahala 7/6/94
Kuluwal Road, Gohal Drive
Sialkot, Pakistan
MID# PKGULINTSIA
Muhkam Tradimg Corp. All Devices/GPI=DE
Anwar Khawaja Road 9/23/04
Near Wapda Grid Station
Sialkot, Pakistan
FEI# 1000196634
Subhani Surgical Corporation All devices
PO Box 821 (including stainless steel
Sialkot, Pakistan surgical instruments)
ID#PKSUBSURSIA 5/25/94
Siemon Surgical Corporation All Devices
Mulahid Pura, Roras Road (Including Stainless
P.O. Box 1630 Steel Surgical
Sialkot, Pakistan Instruments)
MID# PKSIESUR1630SAI 3/29/94
Triumph Industries All devices
57 C/B, Iqbal Road (including stainless steel
Small Industrial Estate surgical instruments)
Sialkot,1, Pakistan 5/20/94
ID#PKTRIIND416SIA
PERU
FIRM PRODUCT
Cirugia S.A All Devices, GPI=DE
Av. Maquinarias 8/9/05
Lima, Peru
FEI# 3002111120
Cirugia Peruna S.A.C. Sterile absorbable steel sutures
Av. Colonial 1255 79GAK
Aptdo. 3624 Sterile non-absorbable steel sutures
Lima 1, Peru 79GAO
FEI #3002111120 7/21/00
SPAIN
FIRM PRODUCT
Idemsa Hemodialyzers
Nicomedes Garcia 40140 (81KHG)
Valverde del Majano 5/2/95
Segovia, Spain
FEI# 1000339390
MID: ESIDE4014SEG
Knickerbocker Laboratories All in vitro Devices
Conde de Borrel 158 (CDRH has requested
Barcelona, 08015, Spain all devices be
MID: ESKNILAB158BAR included under this
FEI #457 revision with specific
concern for the firm"s
VDRL Antigen)
5/16/95
Madespa S.A. Dental amalgam, dental composites,
Rio Jarama, 120 dental adhesives and etching gel;
Toledo, Spain 76DZS; 76EBD; 76EBI; 76EMA
FEI# 3003061923 11/11/08
Productes Clinics, S.A. Thoracic catheters and Trocars
08120 La Llagosta 1/10/94
Barcelona, Spain
SWITZERLAND
FIRM PRODUCT
Argomedical AG All Devices/GPI=DE
Gewerbestrasse 5 12/17/04
Cham, Switzerland
CH-6330
FEI# 3002156857
TAIWAN
FIRM PRODUCT
Honyee Enterprise Co., Ltd. Vinyl Examination Gloves
166-20 Riao Puli, Matou Chem (Powdered, Non-Sterile)/
Tianan Hsien, Taiwan, R.O.C. 80L[][]YZ
MID# TWHONENT1662TAI 11/12/96
FEI# 7035
Linsure Industries, Ltd. All alternating pressure
No. 56 Wu Chuan 3rd Road mattress systems
Wu Ku Industrial Area 80ILA
Taipei, Taiwan 1/31/96
MID# TWLININD56TAI
FEI# 1000189507
Rossmax International Ltd. All Devices
aka Rossmax Innotek GPI=DE
aka Rossmax Medical 5/27/08
aka Rossmax (Taiwan) Int'l.
12F, No. 189, Kang Chien Road
Taipei, Taiwan
FEI# 3003247551
Taiwan Fuji Latex Co. Ltd Condoms
46-3 Pi-Dao Li 85HIS
Tamshui, Taipei Hsien 251 85LTZ
Taiwan 9/14/00
FEI #3002808307
Wan Shou Rubber Industrial Surgical Gloves
Corporation, Ltd. 1/23/96
11 Esia Ta An Yunhan Tsun
Ta An Eoing Tai Chung,
Taiwan, R.O.C.
THAILAND
FIRM PRODUCT
C. Rubber Co., Ltd. Patient Examination Gloves,
162/2 Moo 4 (Powdered, Non-Sterile)
Petchkasame Road OMNO 80L[][]YY
Kratumban 11/12/96
Samutsakorn, Thailand
MID# THRUBCO1622KRA
FEI# 1000134310
Dah Lee Rubber Ind., Ltd. Latex Non-sterile
5/61 Niphutsongkraw 1 Rd. Powdered and Powder-Free
Hatyai, Songkhla 90110 Medical Exam Gloves
Thailand Product Code: 80PRF
MID# THDAHLEE561SON Class: II
FEI# 1000198042 3/6/96
MRI Company, Ltd. Surgeon and Examination Gloves
314/316 Section 5 3/14/95
Surasak, Si Racha
Chon Buri, Thailand
MID# THMRICOM3143CHO
UNITED KINGDOM (INCLUDES ENGLAND, SCOTLAND, WALES, ETC.)
FIRM PRODUCT
Aesculap Ltd. Huckstep Intramedullary Nail
43 Allen Street Huckstep Fine Thread Screw
Sheffield 53 7AX, Huckstep Hip 3 with Aesculap
England, U.K Trunnion
MID #GBAESLTD435AE 8/13/93
APC Medical, Ltd. All medical devices
68 Tewin Road GPI=DE
Welwyn Garden City 10/28/02
United Kingdom AL71BD
FEI# 3002806386
Arjo Med AB Ltd All Devices
St. Catherine Street GPI = DE
Gloucester, GL1 2SL 2/11/05
United Kingdom
FEI# 3002806396
Biosil Limited All Devices
127 Deerdykes View GPI = DE
Westfield Industrial Estate 5/23/00
Cumbernauld, G68 9HN
Glasgow, Scotland
United Kingdom
FEI# 3000289893
J & J Special Products Opthalmic Sutures
Unite 9B, Clive Works Product code: 79HMN, 79HMO
Edward Street 9/7/95
Redditch, Worcestershire,
United Kingdom
MID# UKJJSPEWOR
KeyMed, Ltd. All Devices
KeyMed House, Stock Road GPI=DE
Southend-On-Sea, Essex 7/21/08
United Kingdom, England
FEI# 1000162602
Medical Industrial Anesthesia Machines
Liverton Business Park Product Code:73BSZ,
Salterton Road, Exmouth 6/13/00
Devon EX8 2NR U.K.
FEI #3002806911
Orthodesign, Ltd. Titanium Dental Implants
Unit 19, Sea Vixen Industrial
Estate Wilverley Road 1/20/95
Christchurch, Dorset, England
FEI #1000291790
Smiths Medical International Ltd. Infusion Pumps
Watford, Hertshire 80FRN, 80MEA
United Kingdom 6/19/06
FEI# 3002088009
Sutures, Ltd. All medical devices
Vauxhall Industrial Estate (absorbable and non-
Ruabon Road, County Clwyd absorbable surgical
Wrexham, Wales LL146HA sutures)
United Kingdom GPI=DE
FEI #3002808287 03/31/03
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