Identity
- Trade Name
- Portable Medical Oxygen Concentrator EUDAMED
- Device Name
- Portable Medical Oxygen Concentrator EUDAMED
- Model / Reference
- PO6 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06957469405720 EUDAMED
- Basic UDI-DI
- 6957469401008DX EUDAMED
- Direct Marketing DI
- 06957469405720 EUDAMED
- EMDN Code
- Z12159004 OXYGEN CONCENTRATORS EUDAMED
Classification
- Device Class
- Class IIb 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
Portable Medical Oxygen Concentrator by Shenyang RMS 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 | 6957469401008DX | Class IIb | Active |
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Manufacturer
- Manufacturer
- Shenyang RMS Medical Tech Co., Ltd.
- EUDAMED SRN
- CN-MF-000023286
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED 48fceeed-1657-499f-a451-ee911a0c67a2 61 fields · synced Jun 19, 2026