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ProSense Cryoablation System
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref FAS3100000-2Ref FAS3100000
Identity
- Trade Name
- ProSense Cryoablation System EUDAMED
- Device Name
- ProSense™ Straight Handle 220-240VAC EUDAMEDProSense™ System 220-240VAC EUDAMED
- Model / Reference
- FAS3100000-2 EUDAMEDFAS3100000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290015487306 EUDAMED07290015487177 EUDAMED
- Basic UDI-DI
- B-07290015487306 EUDAMEDB-07290015487177 EUDAMED
- EMDN Code
- Z120102 CRYOSURGERY EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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
ProSense Cryoablation System by Icecure Medical Ltd. — 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
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | DEN220077 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-07290015487306 | Class IIa | Active |
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Manufacturer
- Manufacturer
- IceCure Medical Ltd.
- EUDAMED SRN
- IL-MF-000026406
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (3)
- EUDAMED 91d8ae59-38f5-4963-8627-5788d1eb4a43 61 fields · synced Jul 9, 2026
- EUDAMED d4c9d487-dd49-488a-a63c-ec8b8ac3f02f 61 fields · synced May 18, 2026
- FDA 510(k) DEN220077 1 fields · synced May 18, 2026