Data / Medical devices / Switzerland / Medicel AG
Medicel AG: FDA-registered device maker in Altenrhein Sankt Gallen, Switzerland, 4 510(k) clearances
Medicel AG is registered with the FDA (registration 9681862) in Altenrhein Sankt Gallen, Switzerland. It lists 3 device types. The FDA files 4 510(k) clearances under its listings, the newest dated September 16, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 9681862
- FEI number
- 1000581837
- Address
- Dornierstrasse 11, Altenrhein Sankt Gallen, Switzerland, CH-9423
- Owner or operator
- MEDICEL AG (9027853)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- September 16, 1996
- Registered through
- 2027
- Brand names listed
- 211026 EyeGility Inserter for Preloaded enVista IOLs (2), 211027 EyeGility Inserter for Preloaded enVista IOLs (2.4), 3032-23, ACCUJECT Injector Set 2.1-1P, ACCUJECT Injector Set 2.2-1P, BIT21A, BIT23A, BLIS-X1 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cannula, Ophthalmic | HMX | 1 | Manufacturer | accessdata.fda.gov |
| Folders And Injectors, Intraocular Lens (Iol) | MSS | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Lens, Guide, Intraocular | KYB | 1 | Contract manufacturer, 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 |
|---|---|---|---|---|---|---|
| September 16, 2025 | K252540 | ACCUJECT Injector Set 2.1-1P (LP604590) | MSS | Substantially Equivalent | Medicel AG | accessdata.fda.gov |
| September 19, 2023 | K231106 | Accuject Refra Injector AR2900 | MSS | Substantially Equivalent | Medicel AG | accessdata.fda.gov |
| July 28, 2009 | K092023 | NAVIJECT SUB2-1P, MODEL: LP604430 | MSS | Substantially Equivalent | Medicel AG | accessdata.fda.gov |
| November 1, 2007 | K070669 | IOL INJECTOR SET | KYB | Substantially Equivalent | Medicel AG | accessdata.fda.gov |
Compare with other makers
- All makers of Folders And Injectors, Intraocular Lens (Iol)
- All makers of Lens, Guide, Intraocular
- All makers of Cannula, Ophthalmic
Updated September 16, 2025. 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.