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Positive Airway Pressure Device
EUDAMEDClass IIa (EU MDR)
Ref 108Model CA820MModel CA820M，CA820W，CA820，BA825M，BA825W，BA825，SV825M，SV825W，ST830M，ST830W，ST830，AU830Pro
Identity
- Trade Name
- Positive Airway Pressure Device EUDAMEDPositive Airway Pressure Device（CA820M） EUDAMED
- Device Name
- Positive Airway Pressure Device EUDAMED
- Model / Reference
- CA820M EUDAMED108 EUDAMEDCA820M，CA820W，CA820，BA825M，BA825W，BA825，SV825M，SV825W，ST830M，ST830W，ST830，AU830Pro EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971914891081 EUDAMED
- Basic UDI-DI
- B-06971914891081 EUDAMED697191489VEN8SU EUDAMED
- Direct Marketing DI
- 06971914891081 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, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06971914891081 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06971914891081 | 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 (3)
- EUDAMED ebf25bed-9936-4443-9b87-4d268708b37e 61 fields · synced Jul 11, 2026
- EUDAMED 836d71ee-00ad-465e-824d-81c2369d1428 61 fields · synced Jun 19, 2026
- EUDAMED fc84a32d-6851-46e6-b845-8f76a0c164f5 61 fields · synced Jul 11, 2026