Data / Medical devices / Netherlands / Koninklijke (royal) Utermohlen N.V.
Koninklijke (royal) Utermohlen N.V.: FDA-registered device maker in Wolvega Fryslan, Netherlands, 3 510(k) clearances
Koninklijke (royal) Utermohlen N.V. is registered with the FDA (registration 3010242262) in Wolvega Fryslan, Netherlands. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated November 6, 2015. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3010242262
- Address
- De Overweg 1, Wolvega Fryslan, Netherlands, 8471ZA
- Owner or operator
- Koninklijke (Royal) Utermohlen NV (10043448)
- Roles
- Manufacturer
- First device listed
- February 17, 2013
- Registered through
- 2026
- Brand names listed
- UTERMOHLEN CRYO PROFESSIONAL, WART FREEZE
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Unit, Cryosurgical, Accessories | GEH | 2 | 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 |
|---|---|---|---|---|---|---|
| November 6, 2015 | K152203 | UTERMOHLEN CRYO PROFESSIONAL | GEH | Substantially Equivalent | Koninklijke (Royal) Utermohlen | accessdata.fda.gov |
| June 5, 2013 | K130599 | WART FREEZE | GEH | Substantially Equivalent | Koninklijke Utermohlen NV | accessdata.fda.gov |
| June 23, 2011 | K101049 | WART FREEZE | GEH | Substantially Equivalent | Koninklijke Utermohlen NV | accessdata.fda.gov |
Compare with other makers
Updated November 6, 2015. 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.