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non-rebreathing mask
EUDAMEDClass IIa (EU MDR)
Ref WKM93-001/HSM11-EBModel non-Rebreathing mask
Identity
- Trade Name
- non-rebreathing mask EUDAMED
- Device Name
- Disposable Oxygen Masks EUDAMED
- Model / Reference
- non-Rebreathing mask EUDAMEDWKM93-001/HSM11-EB EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970304312717 EUDAMED
- Basic UDI-DI
- 697030431231100178W 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
non-rebreathing 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 | 697030431231100178W | 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 8639dfa4-7d1d-4dcb-be84-18f1617bca40 61 fields · synced Jun 18, 2026