Identity
- Trade Name
- CPAP System EUDAMED
- Device Name
- Sleep Apnea Therapy Device EUDAMED
- Model / Reference
- G2S C20 EUDAMEDG3 C20 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06948538363157 EUDAMED06948538363218 EUDAMED
- Basic UDI-DI
- 69485383ST001WK EUDAMED
- Direct Marketing DI
- 06948538363157 EUDAMED06948538363218 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
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 |
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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 25a90f63-1c97-4904-a6c0-1ec576e0ad35 61 fields · synced Aug 4, 2026
- EUDAMED 5da70080-5040-4538-8b90-e42a4815cec9 61 fields · synced May 18, 2026