This page includes the latest FDA filings for Gelflex Laboratories. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 9680540 |
| FEI Number | 1000426389 |
| Name | GELFLEX LABORATORIES |
| Owner & Operator | GELFLEX LABORATORIES |
| Contact Address | 52 Mulgul Road Malaga Perth AU-WA Western Australia 6090 AU |
| Official Correspondent |
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| US Agent |
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| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 52 MULGUL ROAD MALAGA PERTH Western Australia, 6090 AU |
| Establishment Type | Manufacture Medical Device |
| Registration Number | 3006406551 |
| FEI Number | 3006406551 |
| Name | PT Gelflex Indonesia |
| Owner & Operator | GELFLEX LABORATORIES |
| Contact Address | 52 Mulgul Road Malaga Perth AU-WA Western Australia 6090 AU |
| Official Correspondent |
|
| US Agent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | Complex Sarana IND. Point Blok A JLN ENGKU Putri No,11 Batam Center Batam Riau, 29461 ID |
| Establishment Type | Sterilize Medical Device for Another Party (Contract Sterilizer) |
Device Company | Device | Date |
|---|---|---|
PT Gelflex Indonesia [GELFLEX LABORATORIES] | Sofclear Enhance | 2019-01-30 |
PT Gelflex Indonesia [GELFLEX LABORATORIES] | Sofclear Comfort | 2019-01-30 |
PT Gelflex Indonesia [GELFLEX LABORATORIES] | Sofclear Colors | 2019-01-30 |
GELFLEX LABORATORIES | Sofclear Enhance | 2019-01-30 |
GELFLEX LABORATORIES | Sofclear Comfort | 2019-01-30 |
GELFLEX LABORATORIES | Sofclear Colors | 2019-01-30 |
PT Gelflex Indonesia [GELFLEX LABORATORIES] | Sofclear Enhance | 2019-01-30 |
PT Gelflex Indonesia [GELFLEX LABORATORIES] | Sofclear Comfort | 2019-01-30 |
PT Gelflex Indonesia [GELFLEX LABORATORIES] | Sofclear Colors | 2019-01-30 |
GELFLEX LABORATORIES | Sofclear Enhance | 2019-01-30 |
GELFLEX LABORATORIES | Sofclear Comfort | 2019-01-30 |
GELFLEX LABORATORIES | Sofclear Colors | 2019-01-30 |
Gelflex Laboratories | Sofclear Enhance (methafilcon A) Daily Wear Contact Lens, Sofclear Colors (methafilcon A) Daily Wear Contact Lens, Sofclear Comfort (methafilcon A) Daily Wear Contact Lens | 2018-09-06 |
GELFLEX LABORATORIES | Boston | 2016-06-16 |
GELFLEX LABORATORIES | Harmony | 2016-06-16 |
GELFLEX LABORATORIES | Gelflex Synergy (polymacon) | 2008-01-15 |
GELFLEX LABORATORIES | Gelflex Synergy (methafilcon A) | 2008-01-15 |
GELFLEX LABORATORIES | Gelflex Synergy (hioxifilcon B) | 2008-01-15 |
GELFLEX LABORATORIES | Gelflex Synergy (efrofilcon A) | 2008-01-15 |
GELFLEX LABORATORIES | Gelflex (hioxifilcon B) Triton | 2008-01-15 |
GELFLEX LABORATORIES | Gelflex Gama (hioxifilcon B) | 2008-01-15 |
GELFLEX LABORATORIES | Gelflex Delta (methafilcon A) 55% | 2008-01-15 |
GELFLEX LABORATORIES | Gelflex Alpha (polymacon) 38% | 2008-01-15 |
GELFLEX LABORATORIES | GELFLEX SYNERGY SOFT LENS HIOXFILCON 49% WATER CONTENT CLEAR OR BLUE VISITINT; GELFLEX HIOXIFILCON SOFT CONTACT LENS 49% | 2003-04-01 |
GELFLEX LABORATORIES | GELFLEX ALPHA (POLYMACON) HYDROPHILIC CONTACT LENS | 1996-09-05 |
GELFLEX LABORATORIES | GELFLEX DELTA 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS | 1996-09-05 |