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RESmart GII BPAP System
EUDAMEDClass IIa (EU MDR)
Ref Y-20TRef Y-30TRef T-20SRef T-30TRef T-20TRef Y-25TRef T-25A
Identity
- Trade Name
- RESmart GII BPAP System EUDAMED
- Device Name
- Non-Invasive Ventilator EUDAMEDSleep Apnea Therapy Device EUDAMED
- Model / Reference
- Y-20T EUDAMEDY-30T EUDAMEDT-20S EUDAMEDT-30T EUDAMEDT-20T EUDAMEDY-25T EUDAMEDT-25A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06948538365816 EUDAMED06948538365830 EUDAMED06948538365113 EUDAMED06948538365090 EUDAMED06948538365137 EUDAMED06948538365823 EUDAMED06948538365014 EUDAMED
- Basic UDI-DI
- 69485383RIV01ZL EUDAMED69485383ST001WK EUDAMED
- Direct Marketing DI
- 06948538365816 EUDAMED06948538365830 EUDAMED06948538365113 EUDAMED06948538365090 EUDAMED06948538365137 EUDAMED06948538365823 EUDAMED06948538365014 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 BPAP 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 | 69485383RIV01ZL | 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 (7)
- EUDAMED ff99ec08-cc60-47c9-bb6e-1e7368863c7b 61 fields · synced Sep 18, 2026
- EUDAMED 38ff638b-1b3f-41de-a07c-c2bb77708025 61 fields · synced May 16, 2026
- EUDAMED 37cb2d7a-808c-4ba8-bd17-bcd62b96fe82 61 fields · synced May 17, 2026
- EUDAMED ebc33e11-3c6a-441d-a06c-a1ed05a9012c 61 fields · synced May 17, 2026
- EUDAMED 3a01cf8f-849b-46f4-b766-32d0aef9123d 61 fields · synced May 18, 2026
- EUDAMED 886b228c-8e56-4cca-813d-b0830441377a 61 fields · synced May 18, 2026
- EUDAMED 51ab683d-4d62-4755-b07a-c0878dd972d0 61 fields · synced May 19, 2026