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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
BIOSTER SPA
CALCINATE (BG), BERGAMO,  IT.
Contract Sterilizer;  
BIOSTER SPA
SERIATE (BG) BERGAMO,  IT.
BIOSTER SPA
SERIATE (BG) BERGAMO,  IT.
Contract Sterilizer;  
BIOSTER SPA
SERIATE (BG) BERGAMO,  IT.
BIOSTOR SYSTEMS, INC.
LOUDONVILLE,  NY,  US.
Specification Developer;  
BIOSTOR SYSTEMS, INC.
LOUDONVILLE,  NY ,  US.
BIOSURE, INC.
GRASS VALLEY,  CA,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
BIOSURE, INC.
GRASS VALLEY,  CA ,  US.
BIOSYN LTD.
BELFAST,  EI.
Manufacturer;  
BIOSYN LTD.
BELFAST,  EI.
BIOSYN SYSTEMS INC.
SURREY, B.C,  CA.
Manufacturer;  
BIOSYN SYSTEMS INC.
SURREY, B.C,  CA.
BIOSYNERGY, INC.
ELK GROVE VILLAGE,  IL,  US.
Manufacturer;  
BIOSYNERGY, INC.
ELK GROVE VILLAGE,  IL ,  US.
BIOSYS CO. LTD.
CHUNG-GU, SEOUL,  KS.
Unregistered Foreign Lister;  
BIOSYS CO. LTD.
CHUNG-GU, SEOUL,  KS.
BIOSYS LABORATORIES, INC.
LA CANADA,  CA,  US.
Initial Importer;  
BIOSYS LABORATORIES, INC.
LA CANADA,  CA ,  US.
BIOSYSTEMS
DACONO,  CO,  US.
Manufacturer;  
STERICYCLE, INC.
LAKE FOREST,  IL ,  US.
BIOSYSTEMS
EAST SYRACUSE,  NY,  US.
Manufacturer;  
STERICYCLE, INC.
LAKE FOREST,  IL ,  US.
BIOSYSTEMS
MORGANTOWN,  PA,  US.
Manufacturer;  
STERICYCLE, INC.
LAKE FOREST,  IL ,  US.
BIOSYSTEMS
ST. PAUL,  MN,  US.
Manufacturer;  
STERICYCLE, INC.
LAKE FOREST,  IL ,  US.
BIOSYSTEMS
STURTEVANT,  WI,  US.
Manufacturer;  
STERICYCLE, INC.
LAKE FOREST,  IL ,  US.
BIOSYSTEMS S.A.
BARCELONA,  SP.
Manufacturer;  
BIOSYSTEMS S.A.
BARCELONA,  SP.
BIOTAGE AB
UPPSALA,  SW.
Manufacturer;  
BIOTAGE AB
UPPSALA,  SW.
BIOTEC USA
WASHINGTON,  DC,  US.
Initial Importer;  
BIOTEC USA
WASHINGTON,  DC ,  US.
BIOTEC, INC.
ZEELAND,  MI,  US.
Manufacturer;  
BIOTEC, INC.
ZEELAND,  MI ,  US.
BIOTECH
EAST, MUMBAI, MAHARASHTRA,  IN.
Manufacturer;  
BIOTECH
EAST, MUMBAI, MAHARASHTRA,  IN.
BIOTECH ATLANTIC, INC.
EATONTOWN,  NJ,  US.
Manufacturer;  
BIOTECH ATLANTIC, INC.
EATONTOWN,  NJ ,  US.
BIO-TECH DEVICES SDN BHD
JOHOR BAHRU, JOROR,  MY.
Contract Manufacturer;   Manufacturer;  
BIO-TECH DEVICES SDN BHD
JOHOR BAHRU, JOROR,  MY.
BIOTECH INTERNATIONAL
SALON DE PROVENCE,  FR.
Manufacturer;   Specification Developer;  
BIOTECH INTERNATIONAL
SALON DE PROVENCE,  FR.
BIOTECH MANUFACTURING CENTER OF TEXAS
ATHENS,  TX,  US.
Contract Manufacturer;  
ATHENS INDUSTRIAL FOUNDATION, INC.
ATHENS,  TX ,  US.
BIOTECH MEDICAL INSTRUMENTS CORP.
HAUPPAUGE,  NY,  US.
Initial Importer;   Specification Developer;   Repackager/Relabeller;  
BIOTECH MEDICAL INSTRUMENTS CORP.
HAUPPAUGE,  NY ,  US.
BIOTECH ONE, INC.
TAIPEI,  TW.
Manufacturer;  
BIOTECH ONE, INC.
TAIPEI,  TW.
BIOTECHNICS CORP.
ZIONSVILLE,  IN,  US.
Initial Importer;  
BIOTECHNICS CORP.
ZIONSVILLE,  IN ,  US.
BIOTECHNICS RESEARCH, INC.
LAKE FOREST,  CA,  US.
Repackager/Relabeller;  
BIOTECHNICS RESEARCH, INC.
LAKE FOREST,  CA ,  US.
BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.
KIRYAT MALACHI,  IS.
Manufacturer;  
FERRING PHARMACEUTICALS, INC.
SUFFERN,  NY ,  US.
BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.
REHOVOT,  IS.
Manufacturer;  
FERRING PHARMACEUTICALS, INC.
SUFFERN,  NY ,  US.
BIO-TECHNOLOGY USA, INC.
MIAMI,  FL,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
BIO-TECHNOLOGY USA, INC.
MIAMI,  FL ,  US.
BIOTECHNOSTIX,INC.
MARKHAM,  CA.
Foreign Exporter;   Repackager/Relabeller;  
BIOTECHNOSTIX,INC.
MARKHAM,  CA.
BIOTECNICA INSTRUMENTS, SPA
ROME,  IT.
Manufacturer;   Remanufacturer;  
BIOTECNICA INSTRUMENTS, SPA
ROME,  IT.
BIOTECX LABORATORIES, INC.
HOUSTON,  TX,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
BIOTECX LABORATORIES, INC.
HOUSTON,  TX ,  US.
BIO-TEK INDUSTRIES, INC.
ATLANTA,  GA,  US.
Contract Manufacturer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
BIO-TEK INDUSTRIES, INC.
ATLANTA,  GA ,  US.
BIO-TEK INSTRUMENTS, INC.
WINOOSKI,  VT,  US.
Initial Importer;   Manufacturer;   Specification Developer;  
BIO-TEK INSTRUMENTS, INC.
WINOOSKI,  VT ,  US.
BIOTEL CO., LTD.
WHASUNG-CITY, KYONGGI-DO,  KS.
Manufacturer;  
BIOTEL CO., LTD.
WHASUNG-CITY, KYONGGI-DO,  KS.
BIOTEMPS DENTAL LABORATORY
IRVINE,  CA,  US.
Manufacturer;  
GLIDEWELL LABORATORIES
NEWPORT BEACH,  CA ,  US.
BIOTEQUE AMERICA, INC.
LANGHORNE,  PA,  US.
Initial Importer;  
BIOTEQUE AMERICA, INC.
LANGHORNE,  PA ,  US.
BIOTEQUE CORP.
TAIPEI,  TW.
Manufacturer;  
BIOTEQUE CORP.
TAIPEI,  TW.
BIOTEQUE MEDICAL (JIANGSU) CO., LTD.
JIANG-SU PROVINCE,  CH.
Manufacturer;  
BIOTEQUE CORP.
TAIPEI,  TW.

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Last Modified: 29 April 2006
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