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oxygen masks
EUDAMEDClass IIa (EU MDR)
Ref TKJ-OM-MModel oxygen masksRef TKJ-OM-XL
Identity
- Device Name
- oxygen masks EUDAMED
- Model / Reference
- oxygen masks EUDAMEDTKJ-OM-M EUDAMEDTKJ-OM-XL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950921000938 EUDAMED06950921000914 EUDAMED
- Basic UDI-DI
- 69509210YQMZYA EUDAMED
- EMDN Code
- R03010201 AIR/OXYGEN MASKS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
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 masks by Taizhou Kangjian Medical Equipments 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 | 69509210YQMZYA | Class IIa | Active |
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Manufacturer
- Manufacturer
- Taizhou Kangjian Medical Equipments Co., Ltd.
- EUDAMED SRN
- CN-MF-000011397
- Authorised Representative
- phoenix Medtech GmbH DE-AR-000007996
Sources (2)
- EUDAMED c87ea2eb-2833-4912-ae53-f345442d10e1 61 fields · synced Oct 6, 2026
- EUDAMED ef4c6f46-e312-443f-9dca-c2cbfbbd95dc 61 fields · synced May 18, 2026