Identity
- Trade Name
- Freezpen 35g EUDAMED
- Device Name
- CryoPen EUDAMED
- Model / Reference
- CL-FP-36 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 15407008483415 EUDAMED
- Basic UDI-DI
- 540700848SHOCPECLFP8G EUDAMED
- Direct Marketing DI
- 15407008483415 EUDAMED
- EMDN Code
- Z120102 CRYOSURGERY EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Freezpen 35g by H&O Equipments nv/sa — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 540700848SHOCPECLFP8G | Class IIa | Active |
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Manufacturer
- Manufacturer
- H&O Equipments nv/sa
- EUDAMED SRN
- BE-MF-000000992
Sources (1)
- EUDAMED 2942a585-ef94-41c0-9c7c-c1a75747ef77 61 fields · synced Jul 14, 2026