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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
SUNCUTE INDUSTRIES CO. LTD.
CHUNG LI CITY,  TW.
Manufacturer;  
SUNCUTE INDUSTRIES CO. LTD.
CHUNG LI CITY,  TW.
SUNDANCE ENTERPRISES, INC.
MOORESVILLE,  IN,  US.
Manufacturer;   Specification Developer;  
SUNDANCE ENTERPRISES, INC.
MOORESVILLE,  IN ,  US.
SUNDER BIOMEDICAL TECH. CO., LTD.
TAICHUNG CITY,  TW.
Manufacturer;  
SUNDER BIOMEDICAL TECH. CO., LTD.
TAICHUNG CITY,  TW.
SUNDOG DISTRIBUTING, INC.
CALGARY, ALBERTA,  CA.
Foreign Exporter;   Manufacturer;  
SUNDOG EYEWEAR
CALGARY, ALBERTA,  CA.
SUNDOG EYEWEAR (PACIFIC) INC.
BELLINGHAM,  WA,  US.
Initial Importer;  
SUNDOG EYEWEAR (PACIFIC) INC.
BELLINGHAM,  WA ,  US.
SUNDOWN INDUSTRIES CORP.
PLAINVIEW,  NY,  US.
Initial Importer;  
SUNDOWN INDUSTRIES CORP.
PLAINVIEW,  NY ,  US.
SUNEHARI EXPORTS LTD.
PHASE-II NOIDA,  IN.
Manufacturer;  
SUNEHARI EXPORTS LTD.
NEW DELHI,  IN.
SUNEHARI SVENDGAARD LABORATORIES
NEW DELHI,  IN.
Manufacturer;  
SUNEHARI SVENDGAARD LABORATORIES
NEW DELHI,  IN.
SUN-EYE VISION PROTECTORS, INC.
NYUGUN, FUKUI,  JA.
Manufacturer;  
SUN-EYE VISION PROTECTORS, INC.
NYUGUN, FUKUI,  JA.
SUNFLEX INDUSTRY SDN. BHD.
KUANTAN,  MY.
Manufacturer;  
SUNFLEX INDUSTRY SDN. BHD.
KUANTAN,  MY.
SUNFLOWER MEDICAL L.L.C.
ELLIS,  KS,  US.
Manufacturer;  
SUNFLOWER MEDICAL L.L.C.
ELLIS,  KS ,  US.
SUNFREE ENTERPRISE CO., LTD.
TAINAN,  TW.
Manufacturer;  
SUNFREE ENTERPRISE CO., LTD.
TAINAN,  TW.
SUNG JAE OPTICAL CO.
DAE GU,  KS.
Unregistered Foreign Lister;  
SUNG JAE OPTICAL CO.
DAE GU,  KS.
SUNG KYUNG CO.
TAEGU,  KS.
Manufacturer;  
SUNG KYUNG CO.
TAEGU,  KS.
SUNG LIM INDUSTRIES, CO., LTD.
PUCHEON-SI,  KS.
Manufacturer;  
GEY SU, LEE
PUCHEON-SI,  KS.
SUNG WON MEDICAL CO., LTD.
CHEONG JU, CHUNG BUK,  KS.
Manufacturer;  
SUNG WON MEDICAL CO., LTD.
CHEONG JU, CHUNG BUK,  KS.
SUNG WOON OPTICAL CO.
BUKGU TAEGU,  KS.
Manufacturer;  
SUNG WOON OPTICAL CO.
BUKGU TAEGU,  KS.
SUNGBO TECH. CO., LTD.
EUIJUNGBU-SHI, KYUNGGI-DO,  KS.
Manufacturer;  
SUNGBO TECH. CO., LTD.
EUIJUNGBU-SHI, KYUNGGI-DO,  KS.
SUNGLAO-PILARES DENTAL CLINIC
MAKATI,  RP.
Reprocessor of single-use devices;   Contract Manufacturer;   Remanufacturer;  
SUNGLAO-PILARES DENTAL CLINIC
MAKATI,  RP.
SUNGLASS DISCOUNTERS, INC.
BELLEAIR,  FL,  US.
Initial Importer;  
SUNGLASS DISCOUNTERS, INC.
BELLEAIR,  FL ,  US.
SUNGLASS EXPERTS
CITY OF INDUSTRY,  CA,  US.
Initial Importer;  
SUNGLASS EXPERTS
CITY OF INDUSTRY,  CA ,  US.
SUNGLASS GALLERY, INC.
TAICHUNG,  TW.
Manufacturer;   Specification Developer;  
SUNGLASS GALLERY, INC.
CHANG-HWA,  TW.
SUNGLASS HUT INTL.
MASON,  OH,  US.
Initial Importer;  
SUNGLASS HUT INTERNATIONAL, INC.
MASON,  OH ,  US.
SUNGLASS HUT TRADING CORPORATION
MCDONOUGH,  GA,  US.
Initial Importer;  
SUNGLASS HUT INTERNATIONAL, INC.
MASON,  OH ,  US.
SUNGLASS INTERNATIONAL LLC
WARWICK,  RI,  US.
Remanufacturer;  
SUNGLASS INTERNATIONAL LLC
WARWICK,  RI ,  US.
SUNGLASS MENAGERIE, INC.
BEACH HAVEN,  NJ,  US.
Initial Importer;  
SUNGLASS MENAGERIE, INC.
BEACH HAVEN,  NJ ,  US.
SUNGLASSES AMERICA CORP.
ALHAMBRA,  CA,  US.
Initial Importer;  
SUNGLASSES AMERICA CORP.
ALHAMBRA,  CA ,  US.
SUNGMIN CORP.
YANGSAN-SI, KYUNGSANGNAM-DO,  KS.
Manufacturer;  
SUNGMIN CORP.
YANGSAN-SI, KYUNGSANGNAM-DO,  KS.
SUNHILL CORPORATION LIMITED
CENTRAL, HONG KONG,  HK.
Foreign Exporter;  
SUNHILL CORPORATION LIMITED
CENTRAL, HONG KONG,  HK.
SUNI IMAGING MICROSYSTEMS, INC.
SAN JOSE,  CA,  US.
Manufacturer;  
SUNI IMAGING MICROSYSTEMS, INC.
SAN JOSE,  CA ,  US.
SUNITALIA, INC.
GOSHEN,  IN,  US.
Initial Importer;  
SUNITALIA, INC.
GOSHEN,  IN ,  US.
SUNJUN ENT., INC.
TAIPEI,  TW.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
SUNJUN ENT., INC.
TAIPEI,  TW.
SUNLAI OPTICAL MANUF. (THAILAND) CORP. LTD.
CHACHOENGSAO,  TH.
Manufacturer;  
SUNLAI OPTICAL MANUF. (THAILAND) CORP. LTD.
CHACHOENGSAO,  TH.
SUNLAND OPTICAL CO.
EL PASO,  TX,  US.
Initial Importer;  
SUNLAND OPTICAL CO.
EL PASO,  TX ,  US.
SUNLEXCE INDUSTRIAL CORP.
TAIPEI,  TW.
Repackager/Relabeller;  
EDWARD SHIH
TAIPEI,  TW.
SUNLIGHT MEDICAL LTD.
TEL AVIV,  IS.
Manufacturer;  
SUNLIGHT MEDICAL LTD.
TEL AVIV,  IS.
SUNLIGHT MEDICAL, INC.
PASADENA,  MD,  US.
Initial Importer;  
SUNLIGHT MEDICAL LTD.
TEL AVIV,  IS.
SUNLIGHT OPTICAL ENTERPRISE CO., LTD.
TAO YUAN,  TW.
Manufacturer;  
SUNLIGHT OPTICAL ENTERPRISE CO., LTD.
TAO YUAN,  TW.
SUNLIKE INDUSTRIES
SIALKOT,  PK.
Unregistered Foreign Lister;  
SUNLIKE INDUSTRIES
SIALKOT,  PK.
SUNLINES HAWAII
OCEAN VIEW,  HI,  US.
Initial Importer;  
SUNLINES HAWAII
OCEAN VIEW,  HI ,  US.

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Last Modified: 29 April 2006
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