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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
P.R. DENTAL PRODUCTS
GUAYNABO,  PR,  US.
Initial Importer;  
P.R. DENTAL PRODUCTS
GUAYNABO,  PR ,  US.
P.S.M. (U.S.A.), INC.
BOCA RATON,  FL,  US.
Initial Importer;  
P.S.M. (U.S.A.), INC.
BOCA RATON,  FL ,  US.
P.T. ABADINUSA USAHASEMESTA
JAKARTA 10001,  ID.
Unregistered Foreign Lister;  
P.T. ABADINUSA USAHASEMESTA
JAKARTA 10001,  ID.
P.T. ASTRON OPTINDO INDUSTRIES
JAKARTA,  ID.
Manufacturer;  
P.T. ASTRON OPTINDO INDUSTRIES
JAKARTA,  ID.
P.T. DAIFATEX INDAH
BANDUNG,  ID.
Manufacturer;  
P.T. DAIFATEX INDAH
BANDUNG,  ID.
P.T. DELTA WARU RUBBER INDUSTRY
WARU, SIDOARJO,  ID.
Manufacturer;  
P.T. DELTA WARU RUBBER INDUSTRY
WARU, SIDOARJO,  ID.
P.T. DWILATEX GLOVINDO
YOGYAKARTA,  ID.
Manufacturer;  
P.T. DWILATEX GLOVINDO
YOGYAKARTA,  ID.
P.T. FULIJAYA TOOTHBRUSH INDONESIA
MEDAN,  ID.
Contract Manufacturer;  
FULIJAYA MANUFACTURING SDN. BHD.
KULIM, KEDAH,  MY.
P.T. GEOMED INDONESIA
SEMARANG, CENTRAL JAVA,  ID.
Manufacturer;  
P.T. GEOMED INDONESIA
SEMARANG, CENTRAL JAVA,  ID.
P.T. GLOVESINDO PRATAMA
SURABAYA,  ID.
Manufacturer;  
P.T. GLOVESINDO PRATAMA
SURABAYA,  ID.
P.T. GOTONG ROJONG DJAJA
INDONESIA,  ID.
Unregistered Foreign Lister;  
P.T. GOTONG ROJONG DJAJA
INDONESIA,  ID.
P.T. GREENLEAF
BATAM,  ID.
Contract Manufacturer;   Manufacturer;  
P.T. GREENLEAF
PERTH, WESTERN AUSTRALIA,  AS.
P.T. HALUWIKO PRATITA
NORTH SUMATRA,  ID.
Manufacturer;  
P.T. HALUWIKO PRATITA
NORTH SUMATRA,  ID.
P.T. HEALTHCARE GLOVINDO
JAKARTA,  ID.
Contract Manufacturer;   Manufacturer;  
P.T. HEALTHCARE GLOVINDO
JAKARTA,  ID.
P.T. IGAR JAYA
JAKARTA,  ID.
Contract Manufacturer;   Manufacturer;  
P.T. IGAR JAYA
JAKARTA,  ID.
P.T. INDOTAMA MAGAH INDAH RUBBER
SURABAYA,  ID.
Manufacturer;  
P.T. INDOTAMA MAGAH INDAH RUBBER
SURABAYA,  ID.
P.T. KENCANA RONASAKTI PRIMA
KABUPATEN BOGOR,  ID.
Manufacturer;  
P.T. KENCANA RONASAKTI PRIMA
WEST JAVA,  ID.
P.T. KREASI BHOJWANIS
JARKARTA,  ID.
Manufacturer;  
KREASI BHOJWANIS
JARKARTA,  ID.
P.T. LATEXINDO PARAMA
MEDAN,  ID.
Manufacturer;  
PIET JAYALIE
MEDAN,  ID.
P.T. LATEXINDO TOBAPERKASA
MEDAN,  ID.
Manufacturer;  
P.T. LATEXINDO TOBAPERKASA
MEDAN,  ID.
P.T. MAJA AGUNG LATEXINDO
SUMATERA-UTARA,  ID.
Manufacturer;  
P.T. MAJA AGUNG LATEXINDO
SUMATERA UTARA,  ID.
P.T. MULTI LATEXINDO
MEDAN,  ID.
Manufacturer;  
P.T. MULTI LATEXINDO
MEDAN,  ID.
P.T. PANCA PUSAKA DELI
MEDAN,  ID.
Manufacturer;  
P.T. PANCA PUSAKA DELI
MEDAN,  ID.
P.T. SAPTINDO SURGICA
MERUYA LLIR RAYA JAKARTA BARAT,  ID.
Unregistered Foreign Lister;  
P.T. SAPTINDO SURGICA
MERUYA LLIR RAYA JAKARTA BARAT,  ID.
P.T. SURYA MILANI PLASTIC UTAMA
JAKARTA PUSAT, INDONESIA,  ID.
Unregistered Foreign Lister;  
P.T. SURYA MILANI PLASTIC UTAMA
JAKARTA PUSAT, INDONESIA,  ID.
P.T. TERUS LANCAR JAYA
SUMEDANG/JAWA BARAT,  ID.
Manufacturer;  
ODJI YAHYA SAPUTRA
BANDUNG. JAWA BARAT,  ID.
P.T. VONIX LATEXINDO CONDOM (RUBBER) MFG.
TANGERANG, WEST JAVA,  ID.
Manufacturer;  
P.T. VONIX LATEXINDO CONDOM (RUBBER) MFG.
TANGERANG, WEST JAVA,  ID.
P.T. WANTONG INDUSTRY
KEC. TAMAN, SIDOARJO,  ID.
Manufacturer;  
P.T. WANTONG INDUSTRY
KEC. TAMAN, SIDOARJO,  ID.
P.W. COOLE & SON LTD.
SOUTHEND-ON-SEA ESSEX,  UK.
Manufacturer;  
P.W. COOLE & SON LTD.
SOUTHEND-ON-SEA ESSEX,  UK.
P.W. MINOR & SON, INC.
BATAVIA,  NY,  US.
Manufacturer;   Specification Developer;  
P.W. MINOR & SON, INC.
BATAVIA,  NY ,  US.
P.W. WOO & SONS, INC.
LOS ANGELES,  CA,  US.
Initial Importer;  
ABC TOYS
LOS ANGELES,  CA ,  US.
PAA LABORATORIES GMBH
PASCHING,  AU.
Manufacturer;  
PAA LABORATORIES GMBH
PASCHING,  AU.
PAA LABORATORIES INC.
ETOBICOKE, ON,  CA.
Contract Manufacturer;   Manufacturer;  
PAA LABORATORIES INC.
ETOBICOKE, ON,  CA.
PAARDEKRACHT HOLDINGS LLC
ST LOUIS,  MO,  US.
Initial Importer;   Specification Developer;  
PAARDEKRACHT HOLDINGS LLC
ST LOUIS,  MO ,  US.
PABISCH S.P.A.
VIA FRATELLI BANDIERA, 13,  IT.
Unregistered Foreign Lister;  
PABISCH S.P.A.
VIA FRATELLI BANDIERA, 13,  IT.
PAC FOAM PRODUCTS CORP.
COSTA MESA,  CA,  US.
Contract Manufacturer;  
PROTECTIVE TECHNOLOGIES, INC.
LAS VEGAS,  NV ,  US.
PAC-DENT INTERNATIONAL (SUZHOU), LTD.
SUZHOU CITY, JIANGSU PROVINCE,  CH.
Manufacturer;  
PAC-DENT INTERNATIONAL (SUZHOU), LTD.
SUZHOU CITY, JIANGSU PROVINCE,  CH.
PAC-DENT INTL., INC.
WALNUT,  CA,  US.
Initial Importer;   Manufacturer;  
PAC-DENT INTL., INC.
WALNUT,  CA ,  US.
PACE MEDICAL
WALTHAM,  MA,  US.
Initial Importer;   Manufacturer;   Repackager/Relabeller;  
PACE MEDICAL
WALTHAM,  MA ,  US.
PACE TECH, INC.
CLEARWATER,  FL,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
PACE TECH, INC.
CLEARWATER,  FL ,  US.

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Last Modified: 29 April 2006
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