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Disposable Oxygen Masks
EUDAMEDClass IIa (EU MDR)
Ref HSMV11-E-BVModel Venturi mask
Identity
- Device Name
- Disposable Oxygen Masks EUDAMED
- Model / Reference
- Venturi mask EUDAMEDHSMV11-E-BV EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970304316128 EUDAMED
- Basic UDI-DI
- 697030431231100148Q EUDAMED
- EMDN Code
- R03010202 VENTURI 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
Yes
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
Disposable Oxygen Masks 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 | 697030431231100148Q | 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 c26071c5-70e2-42cd-9d94-c0e53beda5b7 61 fields · synced Jun 18, 2026