Identity
- Trade Name
- Safe kiss EUDAMED
- Device Name
- CPR mask EUDAMED
- Model / Reference
- SH-5500-5 EUDAMEDP265.241 EUDAMEDp265.244 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974567460758 EUDAMED06974567461502 EUDAMED
- Basic UDI-DI
- 697456746000035Y EUDAMED
- Direct Marketing DI
- 06974567460758 EUDAMED06974567461502 EUDAMED
- EMDN Code
- R03010199 VENTILATION MASKS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Safe kiss by Danyang Sunmed Healthcare Corporation — Class I — 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 | 697456746000035Y | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Danyang Sunmed Healthcare Corporation
- EUDAMED SRN
- CN-MF-000013734
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED c3f18703-5127-4100-a454-d7f4d02742e4 61 fields · synced Oct 6, 2026
- EUDAMED 31668923-c692-4167-b4a4-b7b39ee3c437 61 fields · synced May 18, 2026