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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
SUMEC HARDWARE & TOOLS CO., LTD.
NANJING,  CH.
Manufacturer;  
SUMEC HARDWARE & TOOLS CO., LTD.
NANJING,  CH.
SUMINISTROS INTERNACIONALES, S.A.
SANTO DOMINGO,  DR.
Manufacturer;  
SUMINISTROS INTERNACIONALES, S.A.
SANTO DOMINGO,  DR.
SUMIRUBBER MALAYSIA SDN. BHD.
SUNGAI PETANI, KEDAH,  MY.
Manufacturer;  
SUMIRUBBER MALAYSIA SDN. BHD.
SUNGAI PETANI, KEDAH,  MY.
SUMITOMO ELECTRIC INDUSTRIES, LTD
OSAKA,  JA.
Manufacturer;  
SUMITOMO ELECTRIC INDUSTRIES, LTD
OSAKA,  JA.
SUMITOMO PLASTICS AMERICA, INC.
SANTA CLARA,  CA,  US.
Initial Importer;  
SUMITOMO BAKELITE CO., LTD.
TOKYO,  JA.
SUMMA TRADING CO.
LOS ANGELES,  CA,  US.
Initial Importer;  
SUMMA TRADING CO.
LOS ANGELES,  CA ,  US.
SUMMER INFANT, INC
LINCOLN,  RI,  US.
Initial Importer;  
SUMMER INFANT, INC
LINCOLN,  RI ,  US.
SUMMER ROSE CO., LTD.
BRONX,  NY,  US.
Initial Importer;  
SUMMER ROSE CO., LTD.
BRONX,  NY ,  US.
SUMMERDAYS ENTERPRISE CO., LTD.
CHUNG LI CITY, TAOYUAN,  TW.
Manufacturer;  
SUMMERDAYS ENTERPRISE CO., LTD.
CHUNG LI CITY, TAOYUAN,  TW.
SUMMIT BUSINESS PRODUCTS, INC.
COLUMBIA CITY,  IN,  US.
Contract Manufacturer;  
SUMMIT BUSINESS PRODUCTS, INC.
COLUMBIA CITY,  IN ,  US.
SUMMIT CORPORATE SERVICES, INC.
BOZEMAN,  MT,  US.
Repackager/Relabeller;  
SUMMIT CORPORATE SERVICES, INC.
BOZEMAN,  MT ,  US.
SUMMIT DOPPLER SYSTEMS, INC.
GOLDEN,  CO,  US.
Manufacturer;  
SUMMIT DOPPLER SYSTEMS, INC.
GOLDEN,  CO ,  US.
SUMMIT DURABLE MEDICAL EQUIPMENT, INC.
STAFFORD,  TX,  US.
Initial Importer;  
SUMMIT DURABLE MEDICAL EQUIPMENT, INC.
STAFFORD,  TX ,  US.
SUMMIT GLOBAL SOLUTIONS, LLC
VALENCIA,  CA,  US.
Initial Importer;  
SUMMIT GLOBAL SOLUTIONS, LLC
VALENCIA,  CA ,  US.
SUMMIT GLOVE, INC.
MINERVA,  OH,  US.
Initial Importer;   Specification Developer;  
SUMMIT GLOVE, INC.
MINERVA,  OH ,  US.
SUMMIT INDUSTRIES, INC.
CHICAGO,  IL,  US.
Initial Importer;   Manufacturer;  
SUMMIT INDUSTRIES, INC.
CHICAGO,  IL ,  US.
SUMMIT LIFTS, INC.
LAKE WINNEBAGO,  MO,  US.
Manufacturer;  
SUMMIT LIFTS, INC.
LAKE WINNEBAGO,  MO ,  US.
SUMMIT MARKETING
TULSA,  OK,  US.
Initial Importer;  
SUMMIT MARKETING
TULSA,  OK ,  US.
SUMMIT MEDICAL LTD.
GLOUCESTERSHIRE,  UK.
Manufacturer;  
SUMMIT MEDICAL LTD.
GLOUCESTERSHIRE,  UK.
SUMMIT MEDICAL, INC.
FRANKLIN,  MA,  US.
Specification Developer;   Repackager/Relabeller;  
SUMMIT MEDICAL, INC.
FRANKLIN,  MA ,  US.
SUMMIT MFG. & MACHINING INC.
BREMEN,  IN,  US.
Contract Manufacturer;  
SUMMIT MFG. & MACHINING INC.
BREMEN,  IN ,  US.
SUMMIT NY LLC
NEW YORK,  NY,  US.
Initial Importer;  
SUMMIT NY LLC
NEW YORK,  NY ,  US.
SUMMIT OPTICS, INC.
GAINESVILLE,  FL,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
STARLING SUMMIT EYE TRAYS, INC.
GAINESVILLE,  FL ,  US.
SUMMIT ORTHODONTIC SERVICES, INC.
MONROE FALLS,  OH,  US.
Initial Importer;   Repackager/Relabeller;  
SUMMIT ORTHODONTIC SERVICES, INC.
MONROE FALLS,  OH ,  US.
SUMMIT PRINTING, INC.
WEST MONROE,  LA,  US.
Contract Manufacturer;   Repackager/Relabeller;  
SUMMIT PRINTING, INC.
WEST MONROE,  LA ,  US.
SUMMITECH, INC.
FUKUI CITY,  JA.
Manufacturer;  
SUMMITECH, INC.
FUKUI CITY,  JA.
SUMMITEK, INC.
FLUSHING,  NY,  US.
Initial Importer;  
SUMMITEK, INC.
FLUSHING,  NY ,  US.
SUN AIR, INC.
TOKYO,  JA.
Manufacturer;  
SUN AIR, INC.
TOKYO,  JA.
SUN ALLERGY CONTROL COMPANY
TAICHUNG COUNTY,  TW.
Manufacturer;  
SUN ALLERGY CONTROL COMPANY
TAICHUNG COUNTY,  TW.
SUN AND YOUNG SUNGLASSES CO., LTD.
TAINAN HSIEN,  TW.
Manufacturer;  
SUN AND YOUNG SUNGLASSES CO., LTD.
TAINAN HSIEN,  TW.
SUN BAN FASHIONS (N.Y.), INC.
BROOKLYN,  NY,  US.
Initial Importer;  
SUN BAN FASHIONS (N.Y.), INC.
BROOKLYN,  NY ,  US.
SUN BIOMEDICAL LABORATORIES, INC.
BLACKWOOD,  NJ,  US.
Initial Importer;   Contract Manufacturer;   Manufacturer;  
SUN BIOMEDICAL LABORATORIES, INC.
BLACKWOOD,  NJ ,  US.
SUN BOW, INC.
CHUNG HUA CITY,  TW.
Unregistered Foreign Lister;  
SUN BOW, INC.
CHUNG HUA CITY,  TW.
SUN BRISK INDUSTRIAL CORP.
TAIPEI,  TW.
Manufacturer;  
SUN BRISK INDUSTRIAL CORP.
TAIPEI,  TW.
SUN CATCH ENTERPRISE CO., LTD.
TAIPEI 10630,  TW.
Repackager/Relabeller;  
SUN CATCH ENTERPRISE CO., LTD.
TAIPEI 10630,  TW.
SUN COAST MERCHANDISE CORP.
COMMERCE,  CA,  US.
Initial Importer;  
SUN COAST MERCHANDISE CORP.
COMMERCE,  CA ,  US.
SUN COMPANY
ALEXANDRIA,  VA,  US.
Initial Importer;   Specification Developer;  
SUN COMPANY
ALEXANDRIA,  VA ,  US.
SUN CONCEPTS INTL., INC.
MORELAND HILLS,  OH,  US.
Initial Importer;  
SUN CONCEPTS INTL., INC.
MORELAND HILLS,  OH ,  US.
SUN CORP.
GM.
Unregistered Foreign Lister;  
SUN CORP.
GM.
SUN DAN TOOTHBRUSH CORP.
TAIPEI COUNTY,  TW.
Unregistered Foreign Lister;  
SUN DAN TOOTHBRUSH CORP.
TAIPEI COUNTY,  TW.

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Last Modified: 29 April 2006
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