Data / Medical devices / Germany / Vitromed GMBH
Vitromed GMBH: FDA-registered device maker in Jena Thuringia, Germany, 1 510(k) clearance
Vitromed GMBH is registered with the FDA (registration 3016214552) in Jena Thuringia, Germany. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 28, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016214552
- Address
- Goschwitzer Str. 22, Jena Thuringia, Germany, 07745
- Owner or operator
- VITROMED GmbH (10062050)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- December 13, 2019
- Registered through
- 2026
- Brand names listed
- V-DENUPET, V-ICSIPET, V-OIL
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Media, Reproductive, Exempt | QKI | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Microtools, Assisted Reproduction (Pipettes) | MQH | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Microtools, Assisted Reproduction (Pipettes), Exempt | PUC | 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 |
|---|---|---|---|---|---|---|
| January 28, 2020 | K192146 | V-DENUPET | MQH | Substantially Equivalent | Vitromed GmbH | accessdata.fda.gov |
Compare with other makers
- All makers of Media, Reproductive, Exempt
- All makers of Microtools, Assisted Reproduction (Pipettes), Exempt
- All makers of Microtools, Assisted Reproduction (Pipettes)
Updated January 28, 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.