Identity
- Trade Name
- Sleep Apnoea Breathing Therapy Systems EUDAMED
- Device Name
- Sleep Apnoea Breathing Therapy Systems EUDAMED
- Model / Reference
- BPAP25V EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06957469403818 EUDAMED
- Basic UDI-DI
- 6957469402009E8 EUDAMED
- Direct Marketing DI
- 06957469401135 EUDAMED
- EMDN Code
- Z12030102 CONTINUOUS POSITIVE PRESSURE EQUIPMENT 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Sleep Apnoea Breathing Therapy Systems by Shenyang RMS Medical Tech 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 | 6957469402009E8 | Class IIa | 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 ed6f940a-169e-4ca9-9f6c-57595db26f1a 61 fields · synced Jun 18, 2026