GELFLEX LABORATORIES
- Type
- manufacturer (our classification of the record, not a statement by the company)
- Role
- Manufacturer (official record)
- Location
- PERTH Western Australia, Australia
- Categories
- चिकित्सा एवं स्वास्थ्य देखभाल आपूर्तियाँ
Listed in a source registry
What is established and what is not
No researcher review has been written for this company yet. 5 official records from 4 official sources are on file. 2 other entries are not official records: our own technical checks and searches, open directory listings, our inferences or the company's own statements. Everything is listed below with its evidence type: each entry confirms only what it literally says; none of them is a review. The manufacturing role above rests on the official records listed below, and only as far as each literally goes: a facility registration or licence is not an observation of current production. Nothing here confirms ownership or trading status beyond what each record literally says.
Facts on file, each with its evidence type
- product-authorised-for-sale-holder (record type: product-authorised-for-sale-holder) [official record; status green] Applicant to the US FDA for 1 medical devices: Sofclear Enhance (methafilcon A) Daily Wear Contact Lens, Sofclear Colors (methafilcon A) Daily Wear Contact Lens, Sofclear Comfort (methafilcon A) Daily Wear Contact Lens (K181558, 2018). The applicant answers for the notification; the record does not say who makes the device. A national regulator lists this company as the holder of the registration of products it has authorised for sale in that country. The holder answers for the product on that market; the record does not say the holder makes it. effective since 2026-10-05. FDA premarket notifications 510(k) and De Novo (openFDA, U.S. Food and Drug Administration)
- Registry ID checks out with the state register (record type: registry-id-verified) [official record; status green] Helps confirm the company on this page is the same legal entity as in the register. checked 2026-08-16. Australian Securities and Investments Commission (ASIC) company register
- On the company register (record type: registered-since) [official record; status green] Shows how long the company has been on the state register, which is hard to fake and easy to check. checked 2026-08-16. Australian Securities and Investments Commission (ASIC) company register
- Site address listed in a government regulator's register (record type: facility-registered) [official record; status green] Shows the regulator records a site of this company at a named address. A registration is not an observation of current production. checked 2026-08-07. US FDA device establishment registration (openFDA)
- No match found on the sanctions lists we checked (record type: sanctions-clear) [our own observation, not an official record; name search, no matching candidate] We searched the public sanctions datasets and found no matching candidate. A name search is not full compliance screening. checked 2026-09-02. OpenSanctions
- No match found in the debarment registers we checked (record type: debarment-clear) [our own observation, not an official record; name search, no matching candidate] We searched the public debarment datasets and found no matching candidate. Absence from these lists is a search result, not a certificate. checked 2026-09-02. OpenSanctions
- Registered with the U.S. FDA (active, renewed for the current year) (record type: fda-registered) [official record; status green] Registered with the US food and drug regulator, renewed for the current year. checked 2026-09-02. FDA
Import rules for these goods
- Medical devices sold in the EU must carry CE marking under the Medical Device Regulation (EU) 2017/745, with a conformity assessment matched to the device risk class. European Commission (MDR)
- For the US market, the maker must have an FDA device establishment registration and product listing; most instruments also need 510(k) premarket clearance. US FDA (devices)