← Back to catalogue
Heltiq WartFreezer
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref 140000510(k) K130599
Identity
- Trade Name
- Heltiq WartFreezer EUDAMED
- Device Name
- HeltiQ Wart Freezer EUDAMED
- Model / Reference
- 140000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-08717TD01-140000FWU9 EUDAMED
- Basic UDI-DI
- B-08717TD01-140000FWU9 EUDAMED
- EMDN Code
- Z120102 CRYOSURGERY EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Heltiq WartFreezer by Koninklijke Utermöhlen N.V. — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K130599 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K101049 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08717TD01-140000FWU9 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Koninklijke Utermöhlen N.V.
- EUDAMED SRN
- NL-MF-000004873
- FDA Applicant
- Koninklijke Utermohlen NV
Sources (2)
- EUDAMED 05e48c8b-db3c-4360-ac7e-23ee6394983b 85 fields · synced Jun 18, 2026
- FDA 510(k) K130599 1 fields · synced May 18, 2026