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oxygen mask
EUDAMEDClass IIa (EU MDR)
Ref WKM91-001/HSM11-EModel Disposable Oxygen Masks
Identity
- Trade Name
- oxygen mask EUDAMED
- Device Name
- Disposable Oxygen Masks EUDAMED
- Model / Reference
- Disposable Oxygen Masks EUDAMEDWKM91-001/HSM11-E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970304312700 EUDAMED
- Basic UDI-DI
- 697030431220600059G EUDAMED
- EMDN Code
- R03010201 AIR/OXYGEN MASKS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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 Jiangsu Weikang Jiejing Medical Apparatus 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 | 697030431220600059G | Class IIa | Active |
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Manufacturer
- Manufacturer
- Jiangsu Weikang Jiejing Medical Apparatus Co., Ltd.
- EUDAMED SRN
- CN-MF-000002179
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 52b7eb5c-3838-42d3-a55c-498469d23710 61 fields · synced Jun 19, 2026