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Oxygen Mask
EUDAMEDClass IIa (EU MDR)
Ref OMPXSRef OMPSRef OMPLRef OMPXSSRef OMV6XLSRef OMNMSRef OMPXLSRef OMV2LSRef OMPSSRef OMTXSSRef OMTMSRef OMTLSRef OMNSSRef OMPLS
Identity
- Trade Name
- Oxygen Mask Medium Concentration S EUDAMEDOxygen mask EUDAMED
- Device Name
- Oxygen Mask EUDAMED
- Model / Reference
- OMPXS EUDAMEDOMPS EUDAMEDOMPL EUDAMEDOMPXSS EUDAMEDOMV6XLS EUDAMEDOMNMS EUDAMEDOMPXLS EUDAMEDOMV2LS EUDAMEDOMPSS EUDAMEDOMTXSS EUDAMEDOMTMS EUDAMEDOMTLS EUDAMEDOMNSS EUDAMEDOMPLS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970240894667 EUDAMED06970240895787 EUDAMED06970240895374 EUDAMED06970240898979 EUDAMED06970240899136 EUDAMED06970240895343 EUDAMED06970240899006 EUDAMED06970240899075 EUDAMED06970240899143 EUDAMED06970240899167 EUDAMED06970240899174 EUDAMED06970240899020 EUDAMED06970240898993 EUDAMED
- Basic UDI-DI
- 697024089OMYM-PXSKB EUDAMED697024089OMYM-OMPS3P EUDAMED697024089OMYM-OMPL39 EUDAMED697024089OMSRT EUDAMED
- Direct Marketing DI
- 06970240894667 EUDAMED06970240895787 EUDAMED06970240895374 EUDAMED06970240898979 EUDAMED06970240895343 EUDAMED06970240899006 EUDAMED06970240899075 EUDAMED06970240899143 EUDAMED06970240899167 EUDAMED06970240899174 EUDAMED06970240899020 EUDAMED06970240898993 EUDAMED
- EMDN Code
- R03010201 AIR/OXYGEN MASKS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMEDHungary 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
Oxygen Mask 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-PXSKB | 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 (14)
- EUDAMED 9c6d6d72-f235-424f-b7ab-5bbeb6b7b46c 61 fields · synced Oct 7, 2026
- EUDAMED ef99c6a9-44d2-416f-bea6-9c23b874fdfd 61 fields · synced May 17, 2026
- EUDAMED 5db7966b-1a66-4c4e-833e-149d9e1a3929 61 fields · synced May 18, 2026
- EUDAMED cb1af7a1-1d42-4833-9fa2-2c733fc150c9 61 fields · synced Jun 18, 2026
- EUDAMED 3bcc5680-c73f-4059-839c-b57f15bb9f12 61 fields · synced Jul 9, 2026
- EUDAMED 2c5679af-6c45-4db4-850a-d86933b6479b 61 fields · synced Jul 9, 2026
- EUDAMED e2cc2c54-1202-4fdc-a97b-5cdb08db4905 61 fields · synced Jul 9, 2026
- EUDAMED edfc8cde-0fed-4530-b2c0-ef48777d21cc 61 fields · synced Jul 10, 2026
- EUDAMED f7280c4b-3d10-4a59-b6b6-b60f68dbe6be 61 fields · synced Jul 20, 2026
- EUDAMED aeaece04-941a-41f1-b646-f78b206ef7e0 61 fields · synced Jul 21, 2026
- EUDAMED 32230616-5ecf-4823-8bad-d6d19d352762 61 fields · synced Jul 24, 2026
- EUDAMED 1319ffcf-c3fd-4afe-a790-71e8efcdadce 61 fields · synced Jul 25, 2026
- EUDAMED eb933b92-6f05-44a2-bbf0-ec093612b281 61 fields · synced Jul 27, 2026
- EUDAMED 0d1cbc34-2018-42c0-bd93-efee7462fa07 61 fields · synced Jul 30, 2026