Data / Medical devices / Hungary / CooperVision CL KFT
CooperVision CL KFT: FDA-registered device maker in Gyal Budapest, Hungary, 5 510(k) clearances
CooperVision CL KFT is registered with the FDA (registration 3009108089) in Gyal Budapest, Hungary. It lists 2 device types. The FDA files 5 510(k) clearances under its listings, the newest dated October 20, 2020. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3009108089
- Address
- Gorcsev Ivan Street 7 Building C, Gyal Budapest, Hungary, 2360
- Owner or operator
- COOPERVISION, INC. (9929062)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- November 3, 2014
- Registered through
- 2026
- Brand names listed
- Clariti 1 Day, Clariti 1 Day Multifocal, Clariti 1 Day Toric, iWear Active
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lens, Contact, (Disposable) | MVN | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Lenses, Soft Contact, Daily Wear | LPL | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 20, 2020 | K202756 | Clariti 1 Day (somofilcon A), Clariti 1 Day Toric (somofilcon A), Clariti 1 Day Multifocal (somofilcon A), Clariti 1 Day Multifocal Toric (somofilcon A) | LPL | Substantially Equivalent | CooperVision, Inc. | accessdata.fda.gov |
| December 11, 2018 | K181920 | Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker | LPL | Substantially Equivalent | CooperVision, Inc. | accessdata.fda.gov |
| August 5, 2013 | K130342 | SAUFLON CLARITI (SOMOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER | LPL | Substantially Equivalent | Sauflon Pharmaceuticals, Ltd. | accessdata.fda.gov |
| July 26, 2013 | K130331 | SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENS WITH UV BLOCKER | MVN | Substantially Equivalent | Sauflon Pharmaceuticals, Ltd. | accessdata.fda.gov |
| December 26, 2001 | K013649 | SAUFLON 55 UV SOFT (HYDROPHILIC) CONTACT LENS | LPL | Substantially Equivalent | Sauflon Pharmaceuticals, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated October 20, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.