Pt Gelflex Indonesia

FDA Filings

This page includes the latest FDA filings for Pt Gelflex Indonesia. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3006406551
FEI Number3006406551
NamePT Gelflex Indonesia
Owner & OperatorGELFLEX LABORATORIES
Contact Address52 Mulgul Road Malaga
Perth AU-WA Western Australia 6090 AU
Official Correspondent
  • DAVID MASEL
  • 61-894-434944-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressComplex Sarana IND. Point Blok A JLN ENGKU Putri No,11 Batam Center
Batam Riau, 29461 ID
Establishment TypeSterilize Medical Device for Another Party (Contract Sterilizer)

FDA Filings

Device
Company
DeviceDate
PT Gelflex Indonesia [GELFLEX LABORATORIES]
Sofclear Enhance2019-01-30
PT Gelflex Indonesia [GELFLEX LABORATORIES]
Sofclear Comfort2019-01-30
PT Gelflex Indonesia [GELFLEX LABORATORIES]
Sofclear Colors2019-01-30
PT Gelflex Indonesia [GELFLEX LABORATORIES]
Sofclear Enhance2019-01-30
PT Gelflex Indonesia [GELFLEX LABORATORIES]
Sofclear Comfort2019-01-30
PT Gelflex Indonesia [GELFLEX LABORATORIES]
Sofclear Colors2019-01-30

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