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Auto CPAP System
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref G3 A20Ref G2S A20Ref M1 Mini
Identity
- Trade Name
- Auto CPAP System EUDAMED
- Device Name
- Sleep Apnea Therapy Device EUDAMED
- Model / Reference
- G3 A20 EUDAMEDG2S A20 EUDAMEDM1 Mini EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06948538363225 EUDAMED06948538363164 EUDAMED06948538363263 EUDAMED
- Basic UDI-DI
- 69485383ST001WK EUDAMED
- Direct Marketing DI
- 06948538363225 EUDAMED06948538363164 EUDAMED06948538363263 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
Auto CPAP System by BMC Medical Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K211155 | Class IIa | Active |
| 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 (4)
- EUDAMED a9cba61e-c9b6-4ca4-b6be-e7e03cd0adb5 61 fields · synced Jul 27, 2026
- EUDAMED fa094abc-9926-43b5-9145-d1cd73ebf589 61 fields · synced May 16, 2026
- EUDAMED 5393ffdf-6dfd-4422-9399-8dad48f2bc1a 61 fields · synced May 18, 2026
- FDA 510(k) K211155 1 fields · synced May 18, 2026