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Silicone CPAP Mask
EUDAMEDClass IIa (EU MDR)
Ref SCM0101001Model FL-01, FM-01, FS-01Ref SCM0101002Ref SCM0102002Model NL-01, NM-01, NS-01
Identity
- Trade Name
- Silicone CPAP Mask EUDAMED
- Device Name
- Silicone CPAP Mask EUDAMED
- Model / Reference
- FL-01, FM-01, FS-01 EUDAMEDSCM0101001 EUDAMEDSCM0101002 EUDAMEDNL-01, NM-01, NS-01 EUDAMEDSCM0102002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06946430419590 EUDAMED06946430419606 EUDAMED06946430413147 EUDAMED06946430426017 EUDAMED06946430426024 EUDAMED
- Basic UDI-DI
- 694643043723402Q8 EUDAMED694643043723403QA EUDAMED
- Direct Marketing DI
- 06946430419590 EUDAMED06946430419606 EUDAMED06946430413147 EUDAMED06946430426017 EUDAMED06946430426024 EUDAMED
- EMDN Code
- R0301010201 CPAP MASKS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMEDRomania 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
Silicone CPAP Mask by Xiamen Compower Medical Tech. 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 | 694643043723402Q8 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Xiamen Compower Medical Tech. Co., Ltd.
- EUDAMED SRN
- CN-MF-000011703
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (5)
- EUDAMED 102fac3f-0258-4bca-ae66-0933d53af1f6 61 fields · synced Sep 17, 2026
- EUDAMED 30ee13cf-589a-44f4-a80a-3ac1c0865c4f 61 fields · synced May 16, 2026
- EUDAMED 173dd0c9-fc91-4313-935c-dd9d6fe8e11a 61 fields · synced May 18, 2026
- EUDAMED 81878820-e822-4f0a-a51b-cb3aa70d2a55 61 fields · synced Jul 16, 2026
- EUDAMED 2cc29bd4-51e9-45fa-9df0-30a0073182bb 61 fields · synced Jul 18, 2026