Data / Medical devices / Germany / VITROMED GmbH
VITROMED GmbH: FDA-registered device maker in Langenfeld (Rheinland) North Rhine-Westphalia, Germany, 8 510(k) clearances
VITROMED GmbH is registered with the FDA (registration 3016126174) in Langenfeld (Rheinland) North Rhine-Westphalia, Germany. It lists 4 device types. The FDA files 8 510(k) clearances under its listings, the newest dated March 21, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016126174
- Address
- Raiffeisen Str 15a, Langenfeld (Rheinland) North Rhine-Westphalia, Germany, 40764
- Owner or operator
- VITROMED GmbH (10062050)
- Roles
- Complaint file establishment, Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- December 13, 2019
- Registered through
- 2026
- Brand names listed
- V-DENUPET, V-GRAD, V-HEPES PLUS, V-HYADASE, V-ICSIPET, V-OIL, V-ONESTEP, V-PVP and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Media, Reproductive | MQL | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Media, Reproductive, Exempt | QKI | 2 | Contract manufacturer, Exporter to the US | accessdata.fda.gov |
| Microtools, Assisted Reproduction (Pipettes) | MQH | 2 | Exporter to the US | accessdata.fda.gov |
| Microtools, Assisted Reproduction (Pipettes), Exempt | PUC | 2 | Exporter to the US | 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 |
|---|---|---|---|---|---|---|
| March 21, 2025 | K241833 | V-GRAD | MQL | Substantially Equivalent | Vitromed GmbH | accessdata.fda.gov |
| September 13, 2024 | K240176 | V-VITFREEZE and V-VITWARM | MQL | Substantially Equivalent | Vitromed GmbH | accessdata.fda.gov |
| March 20, 2024 | K232125 | V-PVP | MQL | Substantially Equivalent | Vitromed GmbH | accessdata.fda.gov |
| May 26, 2023 | K222606 | V-HYADASE | MQL | Substantially Equivalent | Vitromed GmbH | accessdata.fda.gov |
| January 31, 2023 | K223117 | V-SPERM WASH | MQL | Substantially Equivalent | Vitromed GmbH | accessdata.fda.gov |
| September 14, 2022 | K213293 | V-HEPES PLUS | MQL | Substantially Equivalent | Vitromed Langenfeld | accessdata.fda.gov |
| November 20, 2020 | K193285 | V-ONESTEP | MQL | Substantially Equivalent | Vitromed GmbH | accessdata.fda.gov |
| January 28, 2020 | K192146 | V-DENUPET | MQH | Substantially Equivalent | Vitromed GmbH | accessdata.fda.gov |
Compare with other makers
- All makers of Media, Reproductive
- All makers of Media, Reproductive, Exempt
- All makers of Microtools, Assisted Reproduction (Pipettes), Exempt
- All makers of Microtools, Assisted Reproduction (Pipettes)
Updated March 21, 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.