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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
BIOTEST AG
DREIEICH,  GM.
Manufacturer;  
FIRST TECHNOLOGY PLC
EGHAM, SURREY,  UK.
BIOTEST DIAGNOSTICS CORP.
DENVILLE,  NJ,  US.
Initial Importer;  
FIRST TECHNOLOGY PLC
EGHAM, SURREY,  UK.
BIOTEST LABORATORIES, INC.
MINNEAPOLIS,  MN,  US.
Contract Manufacturer;   Contract Sterilizer;  
BIOTEST LABORATORIES, INC.
MINNEAPOLIS,  MN ,  US.
BIOTEST MEDICAL CORP.
ROAD TOWN, TORTOLA,  VI.
Foreign Exporter;  
BT MEDICAL INC.
TAICHUNG,  TW.
BIO-TEST MEDICAL, INC.
GIBSONIA,  PA,  US.
Manufacturer;  
BIO-TEST MEDICAL, INC.
GIBSONIA,  PA ,  US.
BIOTEX DIAGNOSTICS
LA PUENTE,  CA,  US.
Repackager/Relabeller;  
GENERAL GOODS CORP.
LA PUENTE,  CA ,  US.
BIOTEX LABS LLC
SAN ANTONIO,  TX,  US.
Initial Importer;  
BIOTEX LABS LLC
SAN ANTONIO,  TX ,  US.
BIOTIS
COMPIEGNE,  FR.
Unregistered Foreign Lister;  
BIOTIS
COMPIEGNE,  FR.
BIO-TISSUE, INC.
MIAMI,  FL,  US.
Manufacturer;   Specification Developer;  
TISSUETECH, INC.
MIAMI,  FL ,  US.
BIOTONIX, INC.
BOUCHERVILLE, QUEBEC,  CA.
Manufacturer;  
BIOTONIX, INC.
BOUCHERVILLE, QUEBEC,  CA.
BIOTOP TECHNOLOGY CO., LTD.
TAIPEI,  TW.
Manufacturer;  
BIOTOP TECHNOLOGY CO., LTD.
TAIPEI,  TW.
BIOTRANSMED PRODUCTS LTD.
DALKEITH, ONTARIO,  CA.
Manufacturer;  
BIOTRANSMED PRODUCTS LTD.
DALKEITH, ONTARIO,  CA.
BIOTRIN TECHNOLOGIES
CO. DUBLIN,  EI.
Manufacturer;  
BIOTRIN HOLDING
CO. DUBLIN,  EI.
BIOTRON DIAGNOSTICS, INC.
HEMET,  CA,  US.
Manufacturer;   Repackager/Relabeller;  
BIOTRON DIAGNOSTICS, INC.
HEMET,  CA ,  US.
BIOTRONICS CORP.
GLENBROOK,  CT,  US.
Initial Importer;  
BIOTRONICS CORP.
GLENBROOK,  CT ,  US.
BIOTRONICS, INC.
DAVIE,  FL,  US.

BIOTRONICS, INC.
DAVIE,  FL ,  US.
BIOTRONIK AG
BULACH,  SZ.
Manufacturer;  
BIOTRONIK GMBH & CO. KG
BERLIN,  GM.
BIOTRONIK GMBH & CO. KG
BERLIN,  GM.
Manufacturer;  
BIOTRONIK GMBH & CO. KG
BERLIN,  GM.
BIOTRONIK, INC.
LAKE OSWEGO,  OR,  US.
Initial Importer;   Repackager/Relabeller;  
BIOTRONIK, INC.
LAKE OSWEGO,  OR ,  US.
BIO-VAC, INC.
SOUTHFIELD,  MI,  US.
Contract Manufacturer;  
BIO-VAC, INC.
SOUTHFIELD,  MI ,  US.
BIOVALVE TECHNOLOGIES, INC.
WESTBOROUGH,  MA,  US.
Manufacturer;  
BIOVALVE TECHNOLOGIES, INC.
WESTBOROUGH,  MA ,  US.
BIOVENTRIX, A CHF TECHNOLOGIES COMPANY
DANVILLE,  CA,  US.
Manufacturer;   Specification Developer;  
CHF TECHNOLOGIES, INC.
DANVILLE,  CA ,  US.
BIOVERIS CORPORATION
GAITHERSBURG,  MD,  US.
Manufacturer;  
BIOVERIS CORPORATION
GAITHERSBURG,  MD ,  US.
BIOVEST INTERNATIONAL, INC.
COON RAPIDS,  MN,  US.
Manufacturer;  
BIOVEST INTERNATIONAL, INC.
MINNEAPOLIS,  MN ,  US.
BIOVIEW LTD.
REHOVOT,  IS.
Manufacturer;  
BIOVIEW LTD.
REHOVOT,  IS.
BIOVIR LABORATORIES, INC.
BENICIA,  CA,  US.
Manufacturer;  
BIOVIR LABORATORIES, INC.
BENICIA,  CA ,  US.
BIOVISION AG
BRUGG,BERN,  SZ.
Contract Manufacturer;   Manufacturer;  
BIOVISION AG
BRUGG, BERN,  SZ.
BIOVISION TECHNOLOGY, LLC
GOLDEN,  CO,  US.
Contract Manufacturer;  
BIOVISION TECHNOLOGY, LLC
GOLDEN,  CO ,  US.
BIOVISION, INC.
WEST VALLEY CITY,  UT,  US.
Initial Importer;  
BIOVISION, INC.
WEST VALLEY CITY,  UT ,  US.
BIOWARE, INC.
TRUMBAUERSVILLE,  PA,  US.
Manufacturer;  
BIOWARE, INC.
TRUMBAUERSVILLE,  PA ,  US.
BIOWAY BIOTECHNOLOGY CO., LTD. YANTAI
YANTAI, SHANDONG,  CH.
Contract Manufacturer;  
BIOWAY BIOTECHNOLOGY CO., LTD. YANTAI
YANTAI, SHANDONG,  CH.
BIOWAY, LLC
SAN DIEGO,  CA,  US.
Repackager/Relabeller;  
BIOWAY, LLC
SAN DIEGO,  CA ,  US.
BIOWERK USA, INC.
MECHANICSBURG,  PA,  US.
Manufacturer;  
BIOWERK USA, INC.
MECHANICSBURG,  PA ,  US.
BIOWEST, INC.
ENGLEWOOD,  CO,  US.

BIOWEST, INC.
ENGLEWOOD,  CO ,  US.
BIOWHITTAKER EUROPE S.P.R.L.
VERVIERS, WALLOON,  BE.
Contract Manufacturer;   Manufacturer;  
CAMBREX BIO SCIENCE WALKERSVILLE INC.
WALKERSVILLE,  MD ,  US.
BIOZONE LABORATORIES, INC.
PITTSBURG,  CA,  US.
Contract Manufacturer;  
BIOZONE LABORATORIES, INC.
PITTSBURG,  CA ,  US.
BIP USA, INC.
NIAGARA FALLS,  NY,  US.
Initial Importer;  
BIP USA, INC.
NIAGARA FALLS,  NY ,  US.
BIPICHANDRA VADILAL SHAH
SURENDRANAGAR, GUJARAT,  IN.
Manufacturer;  
BIPICHANDRA VADILAL SHAH
SURENDRANAGAR, GUJARAT,  IN.
BIPORE, INC.
NORTHVALE,  NJ,  US.
Manufacturer;  
BIPORE, INC.
NORTHVALE,  NJ ,  US.
BIPRESS, INC.
MIAMI BEACH,  FL,  US.
Initial Importer;  
BIPRESS, INC.
MIAMI BEACH,  FL ,  US.

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Last Modified: 29 April 2006
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