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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
SOFI DE CHIHUAHUA
10 Y 11, CHIHUAHUA, CHIB,  MX.
Manufacturer;  
ESSILOR INTERNATIONAL, S.A.
CHARENTON, CEDEX,  FR.
SOFILM TECHNOLOGY CO., LTD.
TAIPEI COUNTY,  TW.
Foreign Exporter;   Manufacturer;  
SOFILM TECHNOLOGY CO., LTD.
TAIPEI COUNTY,  TW.
SOFLEX CONTACT LENS INDUSTRIES LTD.
MISGAV,  IS.
Manufacturer;  
SOFLEX CONTACT LENS INDUSTRIES LTD.
MISGAV,  IS.
SOFRACED
LE PLESSIS GRAMMOIRE,  FR.
Manufacturer;  
SOFRACED
LE PLESSIS GRAMMOIRE,  FR.
SOFRADIM CORPORATION
WRENTHAM,  MA,  US.
Initial Importer;  
SOFRADIM PRODUCTION
TREVOUX,  FR.
SOFRADIM PRODUCTION
TREVOUX,  FR.
Manufacturer;  
SOFRADIM PRODUCTION
TREVOUX,  FR.
SOFT INNOVATIONS, INC.
WILDOMAR,  CA,  US.
Manufacturer;  
SOFT INNOVATIONS, INC.
WILDOMAR,  CA ,  US.
SOFTCHROME, INC.
SAN RAMON,  CA,  US.
Manufacturer;  
SOFTCHROME, INC.
SAN RAMON,  CA ,  US.
SOFT-CORE TEXAS, INC.
NORTH RICHLAND HILLS,  TX,  US.
Initial Importer;  
SOFT-CORE TEXAS, INC.
NORTH RICHLAND HILLS,  TX ,  US.
SOFTECH MEDICAL COMPANY
BAY VILLAGE,  OH,  US.
Initial Importer;   Specification Developer;   Repackager/Relabeller;  
SOFTECH MEDICAL COMPANY
BAY VILLAGE,  OH ,  US.
SOFTEK ENT.
ENGLEWOOD,  CO,  US.
Repackager/Relabeller;  
SOFTEK ENT.
ENGLEWOOD,  CO ,  US.
SOFT-LET LANCET CORP.
CHICAGO,  IL,  US.
Initial Importer;  
SOFT-LET LANCET CORP.
CHICAGO,  IL ,  US.
SOFT-LIGHT TRADING CO.
KOWLOON,  HK.
Manufacturer;  
SOFT-LIGHT TRADING CO.
KOWLOON,  HK.
SOFTLIGHT, INC.
TROV,  MI,  US.
Initial Importer;   Specification Developer;   Repackager/Relabeller;  
SOFTLIGHT, INC.
TROV,  MI ,  US.
SOFTLINK INTERNATIONAL INC.
WHITE PLAINS,  NY,  US.
Initial Importer;  
SOFTLINK INTERNATIONAL INC.
WHITE PLAINS,  NY ,  US.
SOFTLINK INTERNATIONAL PVT.LTD.
PUNE, MAHARASTRA,  IN.
Manufacturer;  
SOFTLINK INTERNATIONAL PVT.LTD.
PUNE, MAHARASTRA,  IN.
SOFT-RAY OPTICAL CORP.
TAO YUAN HSIN,  TW.
Manufacturer;  
SOFT-RAY OPTICAL CORP.
TAO-YUAN CITY,  TW.
SOFT-SERT
LYNBROOK,  NY,  US.
Initial Importer;   Specification Developer;  
SOFT-SERT
LYNBROOK,  NY ,  US.
SOGEVA S.R.L.
BORGOSATOLLO (BS),  IT.
Unregistered Foreign Lister;  
SOGEVA S.R.L.
BORGOSATOLLO (BS),  IT.
SOHNIKS ENDOSCOPY, INC.
EAGAN,  MN,  US.
Manufacturer;  
SOHNIKS ENDOSCOPY, INC.
EAGAN,  MN ,  US.
SOJITZ CORPORATION OF AMERICA
LOS ANGELES,  CA,  US.
Initial Importer;  
SOJITZ CORPORATION OF AMERICA
NEW YORK,  NY ,  US.
SOJITZ CORPORATION OF AMERICA
NEW YORK,  NY,  US.
Initial Importer;  
SOJITZ CORPORATION OF AMERICA
NEW YORK,  NY ,  US.
SOJITZ CORPORATION OF AMERICA
PORTLAND,  OR,  US.
Initial Importer;  
SOJITZ CORPORATION OF AMERICA
NEW YORK,  NY ,  US.
SOKEN PRODUCTS, INC.
CARROLLTON,  TX,  US.
Initial Importer;   Manufacturer;   Repackager/Relabeller;  
SOKEN PRODUCTS, INC.
CARROLLTON,  TX ,  US.
SOL 3, LLC.
DARIEN,  IL,  US.
Remanufacturer;   Repackager/Relabeller;  
SOL 3, LLC.
DARIEN,  IL ,  US.
SOLA ADC LENSES, LTD
WEXFORD,  EI.
Foreign Exporter;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
SOLA INTERNATIONAL, INC.
SAN DIEGO,  CA ,  US.
SOLA ARGENTINA S.A.
CAPITAL FEDERAL,  AR.
Foreign Exporter;   Repackager/Relabeller;  
SOLA INTERNATIONAL, INC.
SAN DIEGO,  CA ,  US.
SOLA BRAZIL- INDUSTRIA OPTICA LTDA
PETROPOLIS RJ,  BR.
Foreign Exporter;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
SOLA INTERNATIONAL, INC.
SAN DIEGO,  CA ,  US.
SOLA CUSTOM COATINGS, INC.
CLACKAMAS,  OR,  US.
Initial Importer;   Remanufacturer;  
SOLA INTERNATIONAL, INC.
SAN DIEGO,  CA ,  US.
SOLA G.J. LENS MANUFACTURING LTD.
GUANGZHOU, PRC,  CH.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
SOLA INTERNATIONAL, INC.
SAN DIEGO,  CA ,  US.
SOLA HONG KONG LTD.
KOWLOON BAY, KOWLOON,  HK.
Foreign Exporter;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
SOLA INTERNATIONAL, INC.
SAN DIEGO,  CA ,  US.
SOLA INTERNATIONAL LOGISTICS SERVICES
LONDON,  UK.
Foreign Exporter;   Repackager/Relabeller;  
SOLA INTERNATIONAL, INC.
SAN DIEGO,  CA ,  US.
SOLA OPTICAL ITALIA SPA
CASTIGLIONE OLONA VARESE,  IT.
Foreign Exporter;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
SOLA INTERNATIONAL, INC.
SAN DIEGO,  CA ,  US.
SOLA OPTICAL JAPAN, LTD.
CHUO-KU, OSAKA,  JA.
Manufacturer;  
SOLA OPTICAL JAPAN, LTD.
CHUO-KU, OSAKA,  JA.
SOLA OPTICAL UK LTD.
BIRMINGHAM,  UK.
Foreign Exporter;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
SOLA INTERNATIONAL, INC.
SAN DIEGO,  CA ,  US.
SOLA OPTICAL-AUSTRALIA
LONSDALE, SA,  AS.
Foreign Exporter;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
SOLA INTERNATIONAL, INC.
SAN DIEGO,  CA ,  US.
SOLA OPTICAL-RESEARCH AND DEVELOPMENT AUSTRALIA
LONSDALE, SA,  AS.
Specification Developer;  
SOLA INTERNATIONAL, INC.
SAN DIEGO,  CA ,  US.
SOLA TECHNOLOGIES
HEBRON,  KY,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
SOLA INTERNATIONAL, INC.
SAN DIEGO,  CA ,  US.
SOLA VENEZUELA-INDUSTRIA OPTICA C.A.
VILLA DE CURA, ARAGUA, AP 337,  VE.
Foreign Exporter;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
SOLA INTERNATIONAL, INC.
SAN DIEGO,  CA ,  US.
SOLACE THERAPEUTICS, INC
CARLSBAD,  CA,  US.
Manufacturer;  
SOLACE THERAPEUTICS, INC
CARLSBAD,  CA ,  US.

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Last Modified: 29 April 2006
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