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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
PT DOMAS INTIGLASS PERDANA
SUMATERA, MEDAN,  ID.
Manufacturer;  
PT DOMAS INTIGLASS PERDANA
SUMATERA, MEDAN,  ID.
PT DUTAMULTI INTIOPTIC PRATAMA
DELI SERDANG,NORTH SUMATRA,  ID.
Manufacturer;  
PT DUTAMULTI INTIOPTIC PRATAMA
DELI SERDANG,NORTH SUMATRA,  ID.
PT INDO ABADI SARIMAKMUR
JAKARTA,  ID.
Unregistered Foreign Lister;  
PT INDO ABADI SARIMAKMUR
JAKARTA,  ID.
PT JMS BATAM
BATAM,  ID.
Contract Manufacturer;  
JMS SINGAPORE PTE. LTD
SINGAPORE,  SN.
PT LATEXX TECHNOLOGIES
MEDAN, SUMATERA,  IN.
Contract Manufacturer;   Manufacturer;  
PT LATEXX TECHNOLOGIES
MEDAN, SUMATERA,  IN.
PT PHARMA POLIMETAL
TANGERANG JAKARTA,  ID.
Unregistered Foreign Lister;  
PT PHARMA POLIMETAL
TANGERANG JAKARTA,  ID.
PT SANKEI MEDICAL INDUSTRIES
CIKANDE SERANG,  ID.
Contract Manufacturer;  
SANKEI CO., LTD.
ICHIHARA-CITY, CHIBA PREF.,  JA.
PT VISION EASE
LIPPO CIKARANG BEKASI,  ID.
Manufacturer;  
INSIGHT EQUITY A.P.X,LP DBA VISION-EASE LENS
SOUTHLAKE,  TX ,  US.
PT. ABBERGUMMI MEDICAL
WARU.SIDOARJO,  ID.
Contract Manufacturer;   Manufacturer;  
PT. ABBERGUMMI MEDICAL
WARU.SIDOARJO,  ID.
PT. ARIADENTA GUNANUSANTARA
JAKARTA, PUSAT,  ID.
Foreign Exporter;   Contract Manufacturer;   Manufacturer;  
PT. ARIADENTA GUNANUSANTARA
JAKARTA, PUSAT,  ID.
PT. BERLIAN GLOVINDO
MEDAN, N.SUMATRA,  ID.
Manufacturer;  
PT. BERLIAN GLOVINDO
MEDAN , N. SUMATRA,  ID.
PT. DHARMA MEDIPRO
TANGERANG,  ID.
Unregistered Foreign Lister;  
PT. DHARMA MEDIPRO
TANGERANG,  ID.
PT. DHARMA POLIMETAL
TANGERANG,  IN.
Unregistered Foreign Lister;  
PT. DHARMA POLIMETAL
TANGERANG,  IN.
PT. HALONI JANE
CIKUPA, TANGERANG,  ID.
Manufacturer;  
PT. HALONI JANE
CIKUPA, TANGERANG,  ID.
PT. HERLIN DHARMA PERSADA
JAKARTA,  ID.
Contract Manufacturer;   Manufacturer;  
PT. HERLIN DHARMA PERSADA
JAKARTA,  ID.
PT. INDOLEX KARYA PRAKARSA
JAKARTA - PUSAT,  ID.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
PT. INDOLEX KARYA PRAKARSA
JAKARTA - PUSAT,  ID.
PT. INDORAYA EVERLATEX
BANJARBARU,  ID.
Manufacturer;  
PT. INDORAYA EVERLATEX
BANJARBARU,  ID.
PT. INDORUB NUSARAYA
MEDAN, SUMATERA UTARA,  ID.
Manufacturer;  
PT. INDORUB NUSARAYA
MEDAN, SUMATERA UTARA,  ID.
PT. INTAN HEVEA INDUSTRY
SUDARSO KM. 10,5, MEDAN,  ID.
Manufacturer;  
PT. INTAN HEVEA INDUSTRY
SUDARSO KM. 10,5, MEDAN,  ID.
PT. IRAMA DINAMIKA LATEX
INDONESIA,  ID.
Manufacturer;  
PT. IRAMA DINAMIKA LATEX
INDONESIA,  ID.
PT. KARYABUDY EKATAMA
BANDUNG,  ID.
Unregistered Foreign Lister;  
PT. KARYABUDY EKATAMA
BANDUNG,  ID.
PT. KH INTERNATIONAL
UTARA,  ID.
Contract Manufacturer;   Manufacturer;  
PT. KH INTERNATIONAL
UTARA,  ID.
PT. MANDIRI INTI BUANA
MORAWA,MEDAN,SUMATERA,UTARA,  ID.
Contract Manufacturer;   Manufacturer;  
PT. MANDIRI INTI BUANA
MORAWA,MEDAN,SUMATERA,UTARA,  ID.
PT. MATTEL INDONESIA
TAHAP 2, BEKASI, JAWA BARAT,  ID.
Repackager/Relabeller;  
PT. MATTEL INDONESIA
TAHAP 2, BEKASI, JAWA BARAT,  ID.
PT. MEDISAFE TECHNOLOGIES
MEDAN, NORTH SUMATERA,  ID.
Contract Manufacturer;   Manufacturer;  
PT. MEDISAFE TECHNOLOGIES
MEDAN, NORTH SUMATERA,  ID.
PT. REL-ION STERILIZATION SERVICES
BEKASI, JAWA BARAT,  ID.
Contract Sterilizer;  
PT.REL-ION STERILIZATION SERVICES
BEKASI, JAWA BARAT,  ID.
PT. SARANA INDOPROTEX
BANDAR, LAMPUNG,  ID.
Manufacturer;  
PT. SARANA INDOPROTEX
BANDAR, LAMPUNG,  ID.
PT. SHAWINDO PELITA CEMERLANG
JAKARTA,  ID.
Manufacturer;  
PT. SHAWINDO PELITA CEMERLANG
JAKARTA,  ID.
PT. SMART GLOVE INDONESIA
MORAWA,DELI SERDANG,SUMATERA U,  ID.
Manufacturer;  
PT. SMART GLOVE INDONESIA
MORAWA,DELI SERDANG,SUMATERA U,  ID.
PT. SUPRAVISI RAMA OPTIK MFG.
KARAWANG, JAWA BARAT,  ID.
Manufacturer;  
PT. SUPRAVISI RAMA OPTIK MFG.
KARAWANG, JAWA BARAT,  ID.
PT. TRIHASTA LOKA PERSADA
TANGERANG,  ID.
Manufacturer;  
PT. TRIHASTA LOKA PERSADA
TANGERANG,  ID.
PT. WIRATARA KRIDA
JAKARTA,  ID.
Repackager/Relabeller;  
PT. WIRATARA KRIDA
JAKARTA,  ID.
PT. WRP BUANA MULTICORPORA
MEDAN,  ID.
Contract Manufacturer;   Manufacturer;  
PT. WRP BUANA MULTICORPORA
MEDAN,  ID.
PT.SHAMROCK MANUFACTURING CORP.
KAB.DELI SERDANG, N.SUMATRA,  ID.
Manufacturer;  
PT.SHAMROCK MANUFACTURING CORP.
MEDAN, N.SUMATRA,  ID.
PTJ INTL.
HEILLECOURT, CEDEX,  FR.
Unregistered Foreign Lister;  
PTJ INTL.
HEILLECOURT, CEDEX,  FR.
PTO MEDTEKHNIKA, LTD.
KAZAN,  RS.
Manufacturer;  
PTP MEDTEKHNIKA, LTD.
KAZAN,  RS.
PTW-FREIBURG
FREIBURG,  GM.
Manufacturer;  
PTW-FREIBURG
FREIBURG,  GM.
PTW-NEW YORK CORP.
HICKSVILLE,  NY,  US.
Initial Importer;  
PTW-FREIBURG
FREIBURG,  GM.
PUBLIC HEALTH INFORMATION SERVICES, INC.
DUBLIN,  OH,  US.
Specification Developer;  
PUBLIC HEALTH INFORMATION SERVICES, INC.
DUBLIN,  OH ,  US.
PUBLICOM, INC.
ROCKY MOUNT,  VA,  US.
Initial Importer;  
PUBLICOM, INC.
ROANOKE,  VA ,  US.

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Last Modified: 29 April 2006
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