Identity
- Trade Name
- Portable Oxygen Concentrator EUDAMED
- Device Name
- Portable Oxygen Concentrator EUDAMED
- Model / Reference
- HPT-10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06953077100484 EUDAMED
- Basic UDI-DI
- 69530771004846N EUDAMED
- Direct Marketing DI
- 06953077100484 EUDAMED
- EMDN Code
- Z12159004 OXYGEN CONCENTRATORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Spain 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
Portable Oxygen Concentrator 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 | 69530771004846N | 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 13f45b55-8787-42f3-90b6-b870de1b95ea 61 fields · synced Jul 15, 2026