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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
SINOCHEM INTERRUB CO.,LTD.
BEIJING,  CH.
Unregistered Foreign Lister;  
SINOCHEM INTERRUB CO.,LTD.
BEIJING,  CH.
SINOCHEM NINGBO IMPORT & EXPORT CORP.
NINGBO, ZHEJIANG,  CH.
Manufacturer;  
SINOCHEM NINGBO IMPORT & EXPORT CORP.
NINGBO, ZHEJIANG,  CH.
SINOCHEM NINGBO LATEX GLOVES FACTORY
NINGBO, ZHEJIANG,  CH.
Manufacturer;  
SINOCHEM NINGBO LATEX GLOVES FACTORY
NINGBO, ZHEJIANG,  CH.
SINOCHEM SHANGHAI IMP./EXP. CORP.
SHANGHAI,  CH.
Unregistered Foreign Lister;  
SINOCHEM SHANGHAI IMP./EXP. CORP.
SHANGHAI,  CH.
SINO-FOREIGN JOINT VENTURE YUYAO BAILIJIE BEARING
ZHEJIANG,  CH.
Manufacturer;  
SINO-FOREIGN JOINT VENTURE YUYAO BAILIJIE BEARING
ZHEJIANG,  CH.
SINOLINK CORP.
INDUSTRY,  CA,  US.
Initial Importer;  
SINOLINK CORP.
INDUSTRY,  CA ,  US.
SINOMAX (HOLDING) GROUP LTD.
TANG XIA TOWN, DONGGUAN,  CH.
Manufacturer;  
SINOMAX (HOLDING) GROUP LTD.
DONGGUAN,  CH.
SINOMAX (HOLDING) GROUP LTD.
HONG KONG,  HK.
Manufacturer;  
SINOMAX (HOLDING) GROUP LTD.
DONGGUAN,  CH.
SINON CORPORATION
TAICHUNG,  TW.
Manufacturer;  
SINON CORPORATION
TAICHUNG,  TW.
SINOPAC MARKETING, INC.
ATLANTA,  GA,  US.
Initial Importer;  
SINOPAC MARKETING, INC.
ATLANTA,  GA ,  US.
SINOPRO INTERNATIONAL LTD.
CENTRAL, HONG KONG,  HK.
Manufacturer;  
SINOPRO INTERNATIONAL LTD.
CENTRAL, HONG KONG,  HK.
SINO-PROTECTION NON-WOVEN PRODUCTS FACTORY
DONG GUAN CITY, GUANG DONG,  CH.
Unregistered Foreign Lister;  
SINO-PROTECTION NON-WOVEN PRODUCTS FACTORY
DONG GUAN CITY, GUANG DONG,  CH.
SINORITA SENDIRIAN BERHAD
CHERAS, SELANGOR,  MY.
Manufacturer;  
INTERNATIONAL PROFIT BUILDERS, INC.
HIGHLAND,  CA ,  US.
SINORITE SDN BHD
CHERAS, SELANGOR,  MY.
Unregistered Foreign Lister;  
SINORITE SDN BHD
CHERAS, SELANGOR,  MY.
SINO-U.S. CHANGZHOU ORIOXI LATEX PRODUCTS CO., LTD
JIANSU PROVINCE, CN,  CH.
Manufacturer;  
CHANGZHOU ORIOXI LATEX PRODUCTS CO LTD.D
JIANSU PROVINCE, CN,  CH.
SINO-US INFORMATION, INC
WOODHAVEN,  NY,  US.
Initial Importer;  
SINO-US INFORMATION, INC
WOODHAVEN,  NY ,  US.
SINO-WORLD CHAMPION CO., LTD.
TAINAN HSIEN,  TW.
Manufacturer;  
SINO-WORLD CHAMPION CO., LTD.
TAINAN HSIEN,  TW.
SINSIN PHARMACEUTICAL CO.,LTD.
ANSAN CITY, KYUNGGI-DO,  KS.
Manufacturer;  
SINSIN PHARMACEUTICAL CO.,LTD.
ANSAN CITY, KYUNGGI-DO,  KS.
SINSIN PHARMACEUTICAL CO.,LTD.
SEOUL,  KS.
Unregistered Foreign Lister;  
SINSIN PHARMACEUTICAL CO.,LTD.
ANSAN CITY, KYUNGGI-DO,  KS.
SINTEA BIOTECH SPA
BARANZATE,  IT.
Manufacturer;  
SINTEA BIOTECH SPA
BARANZATE,  IT.
SINTEA BIOTECH, INC.
MIAMI BEACH,  FL,  US.
Initial Importer;  
SINTEA BIOTECH, INC.
MIAMI BEACH,  FL ,  US.
SINTEC, INC.
EAST WAKEFIELD,  NH,  US.
Initial Importer;  
SINTEC, INC.
EAST WAKEFIELD,  NH ,  US.
SINTES ELECTROMEDICINA, S.A.
PATERNA(VALENCIA),  SP.
Manufacturer;  
JUAN SINTES FAUS
PATERNA(VALENCIA),  SP.
SION AESTHETIC SUPPLY INC.
DALLAS,  TX,  US.
Initial Importer;  
SION AESTHETIC SUPPLY INC.
DALLAS,  TX ,  US.
SION TEXO MEDIC LTD.
UPPER GALILEE,  IS.
Manufacturer;  
SION TEXO MEDIC LTD.
UPPER GALILEE,  IS.
SIPHARM SISSELN AG
SISSELN,  SZ.
Contract Manufacturer;  
SIPHARM SISSELN AG
SISSELIN,  SZ.
SIPLAS S.R.L.
VENEGONO SUPERIOR VARESE,  IT.
Manufacturer;  
SIPLAS S.R.L.
VENEGONO SUPERIOR VARESE,  IT.
SIRCHIE FINGER PRINT LABORATORIES, INC.
YOUNGSVILLE,  NC,  US.
Repackager/Relabeller;  
SIRCHIE FINGER PRINT LABORATORIES, INC.
YOUNGSVILLE,  NC ,  US.
SIRE ANALYTICAL SYSTEMS S.R.L.
UDINE,  IT.
Manufacturer;  
SIRE ANALYTICAL SYSTEMS S.R.L.
UDINE,  IT.
SIRONA DENTAL SYSTEMS GMBH
BENSHEIM,  GM.
Foreign Exporter;   Manufacturer;   Specification Developer;  
SIRONA DENTAL SYSTEMS GMBH
BENSHEIM,  GM.
SIRONA DENTAL SYSTEMS LLC
CHARLOTTE,  NC,  US.
Initial Importer;  
SIRONA DENTAL SYSTEMS LLC
CHARLOTTE,  NC ,  US.
SIRTEX MEDICAL LIMITED
LANE COVE,  AS.
Manufacturer;   Specification Developer;   Repackager/Relabeller;  
SIRTEX MEDICAL LIMITED
LANE COVE,  AS.
SIS LTD. SURGICAL INSTRUMENT SYSTEMS
PORT/BIEL,  SZ.
Manufacturer;  
SIS LTD.
PORT, BERN,  SZ.
SISCO LATEX (P) LTD.
CHENNAI, TAMIL NADU,  IN.
Manufacturer;  
SISCO LATEX (P) LTD.
CHENNAI, TAMIL NADU,  IN.
SISKIYOU PACIFIC, INC.
CENTRAL POINT,  OR,  US.
Manufacturer;  
SISKIYOU PACIFIC, INC.
CENTRAL POINT,  OR ,  US.
SISMA S.P.A.
MANTOVA,  IT.
Unregistered Foreign Lister;  
SISMA S.P.A.
MANTOVA,  IT.
SISSON ENGINEERING CORP.
NORTHFIELD,  MA,  US.
Contract Manufacturer;  
SISSON ENGINEERING CORP.
NORTHFIELD,  MA ,  US.
SISTEMOS MEDICOS ALARIS
SECCION VISTA 1,TIJUAN,BC. CP.,  MX.
Manufacturer;  
CARDINAL HEALTH 303, INC.
SAN DIEGO,  CA ,  US.
SIT MED EQUIPAMENTOS MEDICOS LTDA
FLORES DA CUNHA, RS,  BR.
Contract Manufacturer;  
SIT MED EQUIPAMENTOS MEDICOS LTDA
FLORES DA CUNHA, RS,  BR.
SITA ASSOCIATES
BURR RIDGE,  IL,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
SITA ASSOCIATES
BURR RIDGE,  IL ,  US.

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Last Modified: 29 April 2006
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