Identity
- Trade Name
- NORSE RESCUE Oxygen Mask, Pediatric EUDAMED
- Device Name
- Oxygen mask EUDAMED
- Model / Reference
- OMPM EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970240894957 EUDAMED
- Basic UDI-DI
- 697024089OMYM-OMPM3B EUDAMED
- Direct Marketing DI
- 06970240894957 EUDAMED
- EMDN Code
- R03010201 AIR/OXYGEN MASKS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Denmark 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
NORSE RESCUE Oxygen Mask, Pediatric by Ningbo Luke Medical Devices 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 | 697024089OMYM-OMPM3B | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ningbo Luke Medical Devices Co., LTD
- EUDAMED SRN
- CN-MF-000011732
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 37a1a8c1-990b-4b57-b88b-e47cdb31ac96 61 fields · synced Oct 6, 2026