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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
UNIMED/UNIDENT (USA), LTD.
SAN RAFAEL,  CA,  US.
Initial Importer;  
UNIMED/UNIDENT (USA), LTD.
SAN RAFAEL,  CA ,  US.
UNION ADHESIVE COMPANY, LTD.
SCARBOROUGH, ONTARIO,  CA.
Manufacturer;  
UNION ADHESIVE COMPANY, LTD.
SCARBOROUGH, ONTARIO,  CA.
UNION GEMINI SRL
ROMANO D'EZZELINO VICENZA,  IT.
Manufacturer;  
UNION GEMINI SRL
ROMANO D'EZZELINO VICENZA,  IT.
UNION MEDICAL CO., LTD.
UIJEONGBU-SI, GYEONGGI-DO,  KS.
Manufacturer;  
UNION MEDICAL CO., LTD.
UIJEONGBU-SI, GYEONGGI-DO,  KS.
UNION MEDICAL ENGINEERING CO., LTD.
SEOUL,  KS.
Manufacturer;  
UNION MEDICAL CO., LTD.
UIJEONGBU-SI, GYEONGGI-DO,  KS.
UNION MEDICAL S.A.
MEDELLIN,  CO.
Manufacturer;  
UNION MEDICAL S.A.
MEDELLIN,  CO.
UNION MEDICAL VETERINARY, INC.
ORANGE PARK,  FL,  US.
Initial Importer;   Repackager/Relabeller;  
UNION MEDICAL VETERINARY, INC.
ORANGE PARK,  FL ,  US.
UNION MEDICARE CO., LTD.
NANJING, JIANGSU,  CH.
Manufacturer;  
UNION MEDICARE CO., LTD.
NANJING, JIANGSU,  CH.
UNION OPTICAL CO.
TAEGU,  KS.
Manufacturer;  
UNION OPTICAL CO.
TAEGU,  KS.
UNION POWER INFORMATION IND. CO., LTD.
SHENZHEN,  CH.
Manufacturer;  
UNION POWER INFORMATION IND. CO., LTD.
SHENZHEN,  CH.
UNION RUBBER GLOVES CO., LTD.
BANGKOK,  TH.
Manufacturer;  
UNION RUBBER GLOVES CO., LTD.
BANGKOK,  TH.
UNION TAN INDUSTRIAL CO LTD.
HSINCHU,  TW.
Manufacturer;  
UNION TAN INDUSTRIAL CO LTD.
HSINCHU,  TW.
UNION THAI SOAP TRADING CO., LTD.
BANGKOK,  TH.
Repackager/Relabeller;  
UNION THAI SOAP TRADING CO., LTD.
BANGKOK,  TH.
UNION TOP (H.K.) CO., LTD.
KOWLOON,  HK.
Manufacturer;  
UNION TOP (H.K.) CO., LTD.
KOWLOON,  HK.
UNION TOP CO., LTD.
TAIPEI HSIEN,  TW.
Unregistered Foreign Lister;  
UNION TOP CO., LTD.
TAIPEI HSIEN,  TW.
UNION VISION CO., LIMITED
DISTRICT, BEIJING,  CH.
Foreign Exporter;   Repackager/Relabeller;  
UNION VISION CO., LIMITED
DISTRICT, BEIJING,  CH.
UNION WADDING CO.
PAWTUCKET,  RI,  US.
Manufacturer;  
UNION WADDING CO.
PAWTUCKET,  RI ,  US.
UNIONE
LOS ANGELES,  CA,  US.
Initial Importer;  
UNIONE
LOS ANGELES,  CA ,  US.
UNIOPT GMBH
GRAZ,  AU.
Manufacturer;  
UNIOPT GMBH
GRAZ,  AU.
UNIOPTICAL LIMITED
STREET, TSUEN WAN,  HK.
Manufacturer;  
UNIOPTICAL LIMITED
STREET, TSUEN WAN,  HK.
UNIP
CHERAS, SELANGOR,  MY.
Manufacturer;  
INTERNATIONAL PROFIT BUILDERS, INC.
HIGHLAND,  CA ,  US.
UNIPACK MEDICAL CORP.
COMMERCE,  CA,  US.
Initial Importer;  
UNIPACK MEDICAL CORP.
COMMERCE,  CA ,  US.
UNIPART NORTH AMERICA LIMITED
MAHWAH,  NJ,  US.
Initial Importer;  
UNIPART GROUP OF COMPANIES
OXFORDSHIRE,  UK.
UNI-PATCH, A DIVISION OF TYCO HEALTHCARE GROUP LP
WABASHA,  MN,  US.
Initial Importer;   Contract Manufacturer;   Manufacturer;   Specification Developer;   Repackager/Relabeller;  
TYCO HEALTHCARE GROUP, LP
MANSFIELD,  MA ,  US.
UNIPATH DIAGNOSTIC INC.
WALTHAM,  MA,  US.
Initial Importer;  
INVERNESS MEDICAL INNOVATIONS, INC.
WALTHAM,  MA ,  US.
UNIPATH LTD.
BEDFORD,  UK.
Manufacturer;  
INVERNESS MEDICAL INNOVATIONS, INC.
WALTHAM,  MA ,  US.
UNIPHY ELEKTROMEDIZIN GMBH & CO. KG
HENNIGSDORF,  GM.
Manufacturer;  
UNIPHY ELEKTROMEDIZIN GMBH & CO. KG
HENNIGSDORF,  GM.
UNIPOWER CORP.
MINNEAPOLIS,  MN,  US.
Manufacturer;  
UNIPOWER CORP.
MINNEAPOLIS,  MN ,  US.
UNIQLO USA, INC.
NEW YORK,  NY,  US.
Initial Importer;   Repackager/Relabeller;  
FAST RETAILING CO., LTD.
TOKYO,  JA.
UNIQUE DESIGN AND DEVELOPMENT, LLC.
SHELTON,  CT,  US.
Contract Manufacturer;  
UNIQUE DESIGN AND DEVELOPMENT, LLC.
SHELTON,  CT ,  US.
UNIQUE DISPENSING SYSTEMS, LLC
GUILFORD,  CT,  US.
Manufacturer;  
UNIQUE DISPENSING SYSTEMS, LLC
GUILFORD,  CT ,  US.
UNIQUE HEALTHWARE, INC.
MONTEREY PARK,  CA,  US.
Initial Importer;  
UNIQUE HEALTHWARE, INC.
MONTEREY PARK,  CA ,  US.
UNIQUE INDUSTRIES, INC.
PHILADELPHIA,  PA,  US.
Initial Importer;  
UNIQUE INDUSTRIES, INC.
PHILADELPHIA,  PA ,  US.
UNIQUE INSTRUMENTS, INC.
BRIDGEPORT,  MI,  US.
Contract Manufacturer;  
UNIQUE INSTRUMENTS, INC.
BRIDGEPORT,  MI ,  US.
UNIQUE KING INDUSTRIAL CORP.
TAIPEI,  TW.
Manufacturer;  
UNIQUE KING INDUSTRIAL CORP.
TAIPEI,  TW.
UNIQUE MANAGEMENT ENT., INC.
DELMAR,  NY,  US.
Manufacturer;  
UNIQUE MANAGEMENT ENT., INC.
DELMAR,  NY ,  US.
UNIQUE MEDICAL IMAGING
SEOUL,  KS.
Foreign Exporter;   Repackager/Relabeller;  
UNIQUE MEDICAL IMAGING
SEOUL,  KS.
UNIQUE PROCESS DISTRIBUTORS
TAIPEI,  TW.
Unregistered Foreign Lister;  
UNIQUE PROCESS DISTRIBUTORS
TAIPEI,  TW.
UNIQUE REHAB SOLUTIONS, INC.
MEDIA,  PA,  US.
Manufacturer;  
UNIQUE REHAB SOLUTIONS, INC.
MEDIA,  PA ,  US.
UNIQUE SPORTS PRODUCTS, INC.
ALPHARETTA,  GA,  US.
Initial Importer;   Repackager/Relabeller;  
UNIQUE SPORTS PRODUCTS, INC.
ALPHARETTA,  GA ,  US.

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Last Modified: 29 April 2006
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