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Positive Airway Pressure Device
EUDAMEDClass IIa (EU MDR)
Ref SV825WModel CA820M，CA820W，CA820，BA825M，BA825W，BA825，SV825M，SV825W，ST830M，ST830W，ST830，AU830Pro
Identity
- Trade Name
- Positive Airway Pressure Device EUDAMED
- Device Name
- Positive Airway Pressure Device EUDAMED
- Model / Reference
- CA820M，CA820W，CA820，BA825M，BA825W，BA825，SV825M，SV825W，ST830M，ST830W，ST830，AU830Pro EUDAMEDSV825W EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971914891159 EUDAMED
- Basic UDI-DI
- 697191489VEN8SU EUDAMED
- Direct Marketing DI
- 06971914891159 EUDAMED
- EMDN Code
- Z12030102 CONTINUOUS POSITIVE PRESSURE EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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
Positive Airway Pressure Device by Guangzhou Hypnus Healthcare 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 | 697191489VEN8SU | Class IIa | Active |
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Manufacturer
- Manufacturer
- Guangzhou Hypnus Healthcare Co., Ltd.
- EUDAMED SRN
- CN-MF-000035782
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED bcf4db08-d8f5-4d8b-a113-9b42a0888a6d 61 fields · synced Jun 19, 2026