Identity
- Trade Name
- Oxygen Concentrator for Medical Use EUDAMED
- Device Name
- Oxygen Concentrator for Medical Use EUDAMED
- Model / Reference
- VH5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06953077101238 EUDAMED
- Basic UDI-DI
- 695307710050769 EUDAMED
- Direct Marketing DI
- 06953077101238 EUDAMED
- EMDN Code
- Z12159004 OXYGEN CONCENTRATORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Hungary 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 Concentrator for Medical Use by Shenyang Canta Medical Tech. Co., Ltd. — Class IIb — 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 | 695307710050769 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Shenyang Canta Medical Tech. Co., Ltd.
- EUDAMED SRN
- CN-MF-000014660
- Authorised Representative
- MedNet EC-REP C IIb GmbH DE-AR-000011194
Sources (1)
- EUDAMED 3a19e17f-0f31-47b5-ab12-b907a09270d8 61 fields · synced Jun 19, 2026