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NORSE RESCUE Oxygen Mask w/ Reservoir Pediatric
EUDAMEDClass IIa (EU MDR)
Ref OMPM
Identity
- Trade Name
- NORSE RESCUE Oxygen Mask w/ Reservoir Pediatric EUDAMED
- Device Name
- Oxygen mask EUDAMED
- Model / Reference
- OMPM EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970240894674 EUDAMED
- Basic UDI-DI
- 697024089OMYM-OMPM3B EUDAMED
- Direct Marketing DI
- 06970240894674 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 w/ Reservoir 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 |
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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 b4bc29b5-18d6-442c-acb8-69fc47074079 61 fields · synced Oct 6, 2026