Identity
- Trade Name
- Resuscitation Mask EUDAMED
- Device Name
- Resuscitation Mask EUDAMED
- Model / Reference
- CP641000 EUDAMEDERM0101002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06946430414748 EUDAMED
- Basic UDI-DI
- 694643043606601Q2 EUDAMED
- EMDN Code
- R03010199 VENTILATION MASKS - OTHER 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
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
Resuscitation Mask by Xiamen Compower Medical Tech. Co., Ltd. — 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 | 694643043606601Q2 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Xiamen Compower Medical Tech. Co., Ltd.
- EUDAMED SRN
- CN-MF-000011703
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 1ebea353-d365-4556-8ebf-349a846ab0cb 61 fields · synced Jun 19, 2026