Data / Medical devices / Netherlands / Gynotec B.V.
Gynotec B.V.: FDA-registered device maker in Malden Gelderland, Netherlands, 2 510(k) clearances
Gynotec B.V. is registered with the FDA (registration 3036725842) in Malden Gelderland, Netherlands. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated May 30, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3036725842
- Address
- Rijksweg 150, Malden Gelderland, Netherlands, 6581 ET
- Owner or operator
- Gynotec B.V. (10092680)
- Roles
- Repackager or relabeler
- First device listed
- February 5, 2025
- Registered through
- 2027
- Brand names listed
- SpermCryo All-round, SpermFilter, SpermWash USA
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Media, Reproductive | MQL | 2 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| May 30, 2025 | K242640 | FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicin | MQL | Substantially Equivalent | Fertipro NV | accessdata.fda.gov |
| March 23, 2006 | K053494 | OIL FOR TISSUE CULTURE, GRADIENT SYSTEM AND SPERMFREEZE | MQL | Substantially Equivalent | Fertipro NV | accessdata.fda.gov |
Compare with other makers
Updated May 30, 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.