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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
SUNSWELL ELECTRONICS CO., LTD.
DONG GUAN CITY, GUANG DONG,  CH.
Manufacturer;  
BURTON, INC
WEST DUNDEE,  IL ,  US.
SUNTA OPTICAL CO., LTD.
SHEUNG WAN,  HK.
Foreign Exporter;  
SUNTA OPTICAL CO., LTD.
SHEUNG WAN,  HK.
SUNTAN INDUSTRIAL CO., LTD.
TAINAN,  TW.
Repackager/Relabeller;  
SHU GIE INDUSTRIAL CO., LTD.
TAINAN,  TW.
SUNTECH MEDICAL, INC.
MORRISVILLE,  NC,  US.
Manufacturer;   Specification Developer;   Repackager/Relabeller;  
SUNTECH MEDICAL, INC.
MORRISVILLE,  NC ,  US.
SUNTEK HONG KONG LTD.
SHENZHEN,  CH.
Unregistered Foreign Lister;  
SUNTEK HONG KONG LTD.
SHENZHEN,  CH.
SUNTEKO CO., LTD.
CHANGHUA HSIEN,  TW.
Unregistered Foreign Lister;  
SUNTEKO CO., LTD.
CHANGHUA HSIEN,  TW.
SUNTEX INSTRUMENTS CO., LTD.
TAIPEI, TAIWAN,  TW.
Manufacturer;  
SUNTEX INSTRUMENTS CO., LTD.
TAIPEI, TAIWAN,  TW.
SUNTIN INDUSTRIAL FACTORY
SHENZHEN, GUANGDONG,  CH.
Foreign Exporter;   Contract Manufacturer;   Manufacturer;  
RICOWELL INDUSTRIAL LIMITED
KOWLOON,  HK.
SUNTON ELECTRONICS CO., LTD.
SHENZHEN,  CH.
Contract Manufacturer;   Manufacturer;  
KOTEX ELECTRONICS COMPANY
KOWLOON, HONG KONG,  CH.
SUNTORY INDUSTRIAL CO.
TAIPEI,  TW.
Manufacturer;  
SUNTORY INDUSTRIAL CO.
TAIPEI,  TW.
SUNTRON CORP.
PHOENIX,  AZ,  US.
Contract Manufacturer;  
SUNTRON CORP.
PHOENIX,  AZ ,  US.
SUNTRON CORPORATION
TIJUANA, BAJA CALIFORNIA,  MX.
Contract Manufacturer;  
SUNTRON CORPORATION
PHOENIX,  AZ ,  US.
SUNTRON CORPORATION
GARNER,  IA,  US.
Contract Manufacturer;  
SUNTRON CORPORATION
PHOENIX,  AZ ,  US.
SUNTRON CORPORATION
LAWRENCE,  MA,  US.
Contract Manufacturer;  
SUNTRON CORPORATION
PHOENIX,  AZ ,  US.
SUNTRON CORPORATION
MANCHESTER,  NH,  US.
Contract Manufacturer;  
SUNTRON CORPORATION
PHOENIX,  AZ ,  US.
SUNTRON CORPORATION
NEWBERG,  OR,  US.
Contract Manufacturer;  
SUNTRON CORPORATION
PHOENIX,  AZ ,  US.
SUNTRON CORPORATION
OLATHE,  KS,  US.
Contract Manufacturer;  
SUNTRON CORPORATION
PHOENIX,  AZ ,  US.
SUNTRON CORPORATION
SUGARLAND,  TX,  US.
Contract Manufacturer;  
SUNTRON CORPORATION
PHOENIX,  AZ ,  US.
SUNVISTA IMPORT, INC.
MIAMI,  FL,  US.
Initial Importer;  
SUNVISTA IMPORT, INC.
MIAMI,  FL ,  US.
SUNWAYS (INDIA) PRIVATE, LTD.
GOREGAON (EAST), MUMBAI,  IN.
Manufacturer;  
SUNWAYS (INDIA) PRIVATE, LTD.
GOREGAON (EAST), MUMBAI,  IN.
SUNWEAR OPTICAL LTD.
TSIMSHATSUI, KOWLOON,  HK.
Foreign Exporter;  
SUNWEAR OPTICAL LTD.
TSIMSHATSUI, KOWLOON,  HK.
SUNWELL (XIAMEN) DISPOSABLE DYNAMICS CO., LTD.
XIAMEN, FUJIAN,  CH.
Foreign Exporter;   Manufacturer;  
SUNWELL DYNAMICS RESOURCES CORP.
TAIPEI,  TW.
SUNWELL INT'L CORP.
TAICHUNG CITY,  TW.
Manufacturer;  
SUNWELL INT'L CORP.
TAICHUNG CITY,  TW.
SUNWHA KIANG OPTICAL MFY. (SHENZHEN) CO., LTD.
SHENZHEN,  CH.
Manufacturer;  
SUNWHA KIANG OPTICAL MFY. (SHENZHEN) CO., LTD.
SHENZHEN,  CH.
SUOMEN BIOANALYTIKKA OY,SBA-SCIENCES
TURKU,  FI.
Manufacturer;  
SUOMEN BIOANALYTIKKA OY,SBA-SCIENCES
TURKU,  FI.
SUOSEONG OPTICAL MFG.
TAEGU,  KS.
Manufacturer;  
SUOSEONG OPTICAL MFG.
TAEGU,  KS.
SUPER FLOWER ENTERPRISES CO.LTD.
TAINAN,  TW.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
SUPER FLOWER ENTERPRISES CO.LTD.
TAINAN,  TW.
SUPER GLIDE, INC.
BURLINGTON,  VT,  US.
Specification Developer;  
SUPER GLIDE, INC.
BURLINGTON,  VT ,  US.
SUPER GLOVE INDUSTRY CO., LTD.
BANGKOK,  TH.
Manufacturer;  
SUPER GLOVE INDUSTRY CO., LTD.
BANGKOK,  TH.
SUPER IDEAL MFY.CO., LTD.
GUANGMING TOWN, SHENZHEN,  CH.
Manufacturer;  
SUPER IDEAL MFY.CO., LTD.
GUANGMING TOWN, SHENZHEN,  CH.
SUPER LINES INTL. CORP.
TAIPEI,  TW.
Manufacturer;  
SUPER LINES INTL. CORP.
TAIPEI,  TW.
SUPER MASTER DEVELOPING CO., LTD.
TAIPEI, TAIWAN,  TW.
Unregistered Foreign Lister;  
SUPER MASTER DEVELOPING CO., LTD.
TAIPEI, TAIWAN,  TW.
SUPER ONE VISION
DALY CITY,  CA,  US.
Initial Importer;  
SUPER ONE VISION
DALY CITY,  CA ,  US.
SUPER OPTICAL, INC.
HIALEAH,  FL,  US.
Initial Importer;  
SUPER OPTICAL, INC.
HIALEAH,  FL ,  US.
SUPER SPRING ORTHODONTICS, LLC
BURLINGTON,  WI,  US.
Manufacturer;   Specification Developer;   Repackager/Relabeller;  
SUPER SPRING ORTHODONTICS, LLC
BURLINGTON,  WI ,  US.
SUPER STOCKINGS OF RENO, LLC.
RENO,  NV,  US.
Initial Importer;  
SUPER STOCKINGS OF RENO, LLC.
RENO,  NV ,  US.
SUPER UPSTAST ENT. CO., LTD.
HSH-CHIH CITY,  TW.
Manufacturer;  
SUPER UPSTAST ENT. CO., LTD.
HSH-CHIH CITY,  TW.
SUPER USA MANUFACTURING, INC.
BROOKLYN,  NY,  US.
Initial Importer;  
SUPER USA MANUFACTURING, INC.
BROOKLYN,  NY ,  US.
SUPERCARE MEDICAL CORPORATION
CAGUAS,  PR,  US.
Initial Importer;  
SUPERCARE MEDICAL CORPORATION
CAGUAS,  PR ,  US.
SUPERCOMAL MEDICAL PRODUCTS, SDN BHD
SUNGAI PETANI, KEDAH D.A.,  MY.
Contract Manufacturer;  
SUPERCOMAL MEDICAL PRODUCTS, SDN BHD
SUNGAI PETANI, KEDAH D.A.,  MY.

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Last Modified: 29 April 2006
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