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US Food and Drug Administration (FDA) - Establishment Registration

FDA Registered Companies - Updated May 2006

What is Establishment Registration?

Establishments involved in the production and distribution of medical devices intended for marketing or leasing (commercial distribution) in the United States (U.S.) are required to register with the FDA. This process is known as establishment registration.
FDA Registrations
FDA Registrations
FDA Registrations
FDA Registrations


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Establishment Owner/Operator
UNIVERSAL MEDICAL SYSTEMS, INC.
BEDFORD HILLS,  NY,  US.
Initial Importer;   Remanufacturer;  
UNIVERSAL MEDICAL SYSTEMS, INC.
BEDFORD HILLS,  NY ,  US.
UNIVERSAL MEDICAL TECHNOLOGIES
SAN RAFAEL,  CA,  US.
Initial Importer;   Manufacturer;   Specification Developer;   Repackager/Relabeller;  
UNIVERSAL MEDICAL TECHNOLOGIES, INC.
LARKSPUR,  CA ,  US.
UNIVERSAL MEDICAL, INC.
TRENTON,  NJ,  US.
Manufacturer;  
UNIVERSAL MEDICAL, INC.
TRENTON,  NJ ,  US.
UNIVERSAL MEDSURGE SUPPLIES INC.
HUNTINGTON STATION,  NY,  US.
Initial Importer;  
UNIVERSAL MEDSURGE SUPPLIES INC.
HUNTINGTON STATION,  NY ,  US.
UNIVERSAL OPHTHALMIC INSTRUMENTS, INC.
SPRING,  TX,  US.
Initial Importer;  
UNIVERSAL OPHTHALMIC INSTRUMENTS, INC.
SPRING,  TX ,  US.
UNIVERSAL OPTICS GROUP, INC.
HALLANDALE,  FL,  US.
Initial Importer;  
UNIVERSAL OPTICS GROUP, INC.
HALLANDALE,  FL ,  US.
UNIVERSAL PACS, INC.
KENNER,  LA,  US.
Manufacturer;  
UNIVERSAL PACS, INC.
KENNER,  LA ,  US.
UNIVERSAL PAIN TECHNOLOGY CANADA INC.
PRINCE GEORGE,BRITISH COLUMBIA,  CA.
Repackager/Relabeller;  
UNIVERSAL PAIN TECHNOLOGY CANADA INC.
PRINCE GEORGE,BRITISH COLUMBIA,  CA.
UNIVERSAL PEACE LTD.
TAIPEI,  TW.
Specification Developer;  
TOPSHINE TECHNOLOGY CORP.
TAICHUNG,  TW.
UNIVERSAL PHOTONICS, INC.
HICKSVILLE,  NY,  US.
Initial Importer;  
UNIVERSAL PHOTONICS, INC.
HICKSVILLE,  NY ,  US.
UNIVERSAL SALES AGENCY, INC.
SANFORD,  FL,  US.
Initial Importer;  
UNIVERSAL SALES AGENCY, INC.
SANFORD,  FL ,  US.
UNIVERSAL SEWING SUPPLY
ST. LOUIS,  MO,  US.
Specification Developer;  
UNIVERSAL SEWING SUPPLY
ST. LOUIS,  MO ,  US.
UNIVERSAL STUDIOS FLORIDA
ORLANDO,  FL,  US.
Initial Importer;  
UNIVERSAL CITY FLORIDA PARTNERS
ORLANDO,  FL ,  US.
UNIVERSAL SURGICAL APPLIANCE CO.
MIAMI,  FL,  US.
Manufacturer;  
UNIVERSAL SURGICAL APPLIANCE CO.
MIAMI,  FL ,  US.
UNIVERSAL TECHNOLOGY SYSTEMS, INC.
JACKSONVILLE,  FL,  US.
Manufacturer;  
UNIVERSAL TECHNOLOGY SYSTEMS, INC.
JACKSONVILLE,  FL ,  US.
UNIVERSAL TEXTILE IMPEX
KARACHI, SINDH,  PK.
Foreign Exporter;   Manufacturer;  
UNIVERSAL TEXTILE IMPEX
KARACHI, SINDH,  PK.
UNIVERSAL TRADING CENTER (USA)
OAKLAND,  CA,  US.
Initial Importer;  
UNIVERSAL TRADING CENTER (USA)
OAKLAND,  CA ,  US.
UNIVERSAL TRUMPS CORPORATION
TAIPEI,  TW.
Manufacturer;  
UNIVERSAL TRUMPS CORPORATION
TAIPEI,  TW.
UNIVERSAL UNIVIS EYEWEAR CORP.
PLAINVILLE,  MA,  US.
Initial Importer;  
UNIVERSAL UNIVIS EYEWEAR CORP.
PLAINVILLE,  MA ,  US.
UNIVERSAL WEAVERS CORP.
MARIVELES, BATAAN,  RP.
Manufacturer;   Specification Developer;  
UNIVERSAL WEAVERS CORP.
MARIVELES, BATAAN,  RP.
UNIVERSE TRADING CO., INC.
LIDO BEACH,  NY,  US.
Initial Importer;  
UNIVERSE TRADING CO., INC.
LIDO BEACH,  NY ,  US.
UNIVERSITY MEDICAL SUPPLY CO.
ROCHESTER,  NY,  US.
Initial Importer;  
UNIVERSITY MEDICAL SUPPLY CO.
ROCHESTER,  NY ,  US.
UNIVERSITY OF IOWA - COLLEGE OF PHARMACY
IOWA CITY,  IA,  US.
Contract Manufacturer;  
UNIVERSITY OF IOWA - COLLEGE OF PHARMACY
IOWA CITY,  IA ,  US.
UNIVERSITY OF MASSACHUSETTS LOWELL RADIATION LABOR
LOWELL,  MA,  US.
Contract Sterilizer;  
UNIVERSITY OF MASSACHUSETTS LOWELL
LOWELL,  MA ,  US.
UNIVERSITY OF TEXAS MEDICAL UTMB
GALVESTON,  TX,  US.
Repackager/Relabeller;  
ENVIROCLEAN MANAGEMENT SERVICES, INC.
DALLAS,  TX ,  US.
UNIVERSITY OF UTAH HOSPITALS AND CLINICS
SALT LAKE CITY,  UT,  US.
Reprocessor of single-use devices;   Manufacturer;   Specification Developer;  
UNIVERSITY OF UTAH HOSPITALS AND CLINICS
SALT LAKE CITY,  UT ,  US.
UNIVERSITY OF WASHINGTON
SEATTLE,  WA,  US.
Manufacturer;  
STATE OF WASHINGTON
OLYMPIA,  WA ,  US.
UNIVERSITY OF WASHINGTON
SEATTLE,  WA,  US.
Contract Manufacturer;   Manufacturer;  
STATE OF WASHINGTON
OLYMPIA,  WA ,  US.
UNIVET S.R.L.
REZZATO, BRESCIA,  IT.
Manufacturer;  
UNIVET S.R.L.
REZZATO, BRESCIA,  IT.
UNIWEL INDUSTRIAL CO., LTD.
TAIPEI,  TW.
Manufacturer;  
UNIWEL INDUSTRIAL CO., LTD.
TAIPEI,  TW.
UNIWORLD FZE
JEBEL ALI, DUBAI,  TC.
Manufacturer;  
UNIWORLD FZE
JEBEL ALI, DUBAI,  TC.
UNIWORTH ENTERPRISES
SIALKOT, PB, PUNJAB,  PK.
Foreign Exporter;   Manufacturer;  
UNIWORTH ENTERPRISES
SIALKOT, PB, PUNJAB,  PK.
UNIX ELECTRONIC CO. LTD.
SEOUL,  KS.
Manufacturer;  
UNIX ELECTRONIC CO. LTD.
SEOUL,  KS.
UNIYAC INDUSTRY CO., LTD.
TAIPEI,  TW.
Unregistered Foreign Lister;  
UNIYAC INDUSTRY CO., LTD.
TAIPEI,  TW.
UNLIMITED SKILLS INC.
MONTREAL, QUEBEC,  CA.
Repackager/Relabeller;  
UNLIMITED SKILLS INC.
MONTREAL, QUEBEC,  CA.
UNOMEDICAL A/S
HAARLEV,  DA.
Manufacturer;  
UNOMEDICAL A/S
BIRKEROD,  DA.
UNOMEDICAL A/S
HUNDESTED,  DA.
Manufacturer;  
UNOMEDICAL A/S
BIRKEROD,  DA.
UNOMEDICAL A/S
LYNGE,  DA.
Contract Manufacturer;   Manufacturer;   Contract Sterilizer;  
UNOMEDICAL A/S
BIRKEROD,  DA.
UNOMEDICAL A/S
OSTED, ROSKILDE,  DA.
Manufacturer;  
UNOMEDICAL A/S
BIRKEROD,  DA.
UNOMEDICAL DEVICE S.A. DE C.V.
REYNOSA, TAMAULIPAS,  MX.
Manufacturer;  
UNOMEDICAL A/S
BIRKEROD,  DA.

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Last Modified: 29 April 2006
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