Data / Medical devices / Netherlands / Synthon B.V.
Synthon B.V.: FDA-registered device maker in Nijmegen Gelderland, Netherlands, 1 510(k) clearance
Synthon B.V. is registered with the FDA (registration 3038138498) in Nijmegen Gelderland, Netherlands. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated December 2, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3038138498
- Address
- Microweg 22, Nijmegen Gelderland, Netherlands, 6545
- Owner or operator
- Synthon B.V. (10092950)
- Roles
- Exporter to the US
- First device listed
- March 10, 2025
- Registered through
- 2026
- Brand names listed
- GripMate
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Introducer, Syringe Needle | KZH | 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 |
|---|---|---|---|---|---|---|
| December 2, 2024 | K243232 | GripMate | KZH | Substantially Equivalent | Synthon Hispania S.L. | accessdata.fda.gov |
Compare with other makers
Updated December 2, 2024. 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.