Identity
- Trade Name
- CryoPen O+ EUDAMED
- Device Name
- CryoPen EUDAMED
- Model / Reference
- S-HO-COPE-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 15407008480315 EUDAMED
- Basic UDI-DI
- 540700848SHOCPECLFP8G EUDAMED
- Direct Marketing DI
- 15407008480315 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
CryoPen O+ 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 2c2c58eb-9877-4f06-a66b-89e607c74998 61 fields · synced Jul 10, 2026