Identity
- Device Name
- CPR Masks EUDAMED
- Model / Reference
- EH-001 EUDAMEDEH-002B EUDAMEDEH-002A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974737271535 EUDAMED06974737271528 EUDAMED
- Basic UDI-DI
- 697473727CPRMask001NS EUDAMED
- EMDN Code
- R03010201 AIR/OXYGEN MASKS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Norway 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
CPR Masks by Shanghai Emss Med&Tech Co., Ltd — 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 | 697473727CPRMask001NS | Class I | Active |
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Manufacturer
- Manufacturer
- Shanghai Emss Med&Tech Co., Ltd
- EUDAMED SRN
- CN-MF-000008860
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED 30d8f62b-6e1f-4ae5-85d6-9ec2f0c677c1 61 fields · synced Jul 10, 2026
- EUDAMED 81c8ee4c-b287-4fab-928c-ba25b846ac88 61 fields · synced May 18, 2026