← Back to catalogue
RESmart GII Auto CPAP System
EUDAMEDClass IIa (EU MDR)
Ref E-20A-H-ORef E-20AJ-H-O
Identity
- Trade Name
- RESmart GII Auto CPAP System EUDAMED
- Device Name
- Sleep Apnea Therapy Device EUDAMED
- Model / Reference
- E-20A-H-O EUDAMEDE-20AJ-H-O EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06948538363034 EUDAMED06948538363041 EUDAMED
- Basic UDI-DI
- 69485383ST001WK EUDAMED
- Direct Marketing DI
- 06948538363034 EUDAMED06948538363041 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
RESmart GII Auto CPAP System by BMC Medical 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 | 69485383ST001WK | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- BMC Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000010157
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 26bafdaf-0c01-4e2d-968f-02c6e4cec222 61 fields · synced Jul 22, 2026
- EUDAMED 16a6e072-16a4-42c5-bb3d-d09846c02a13 61 fields · synced May 19, 2026