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Hyperventilation Mask
EUDAMEDClass IIa (EU MDR)
Ref THBM06-HV2000EModel hyperventilation mask
Identity
- Trade Name
- Hyperventilation Mask EUDAMED
- Device Name
- Disposable Oxygen Masks EUDAMED
- Model / Reference
- hyperventilation mask EUDAMEDTHBM06-HV2000E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970304312434 EUDAMED
- Basic UDI-DI
- 697030431231100188Y 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Hyperventilation 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 | 697030431231100188Y | 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 4dcd436d-c9ba-446e-b5cf-223a0db3891d 61 fields · synced Jul 30, 2026