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Topsonmed, Fm60-M
EUDAMEDClass I (EU MDR)
Ref 697385583MASK01TUModel FM50,FM60,NM50,NM60,FM50-NV
Identity
- Trade Name
- TOPSONMED, FM60-M EUDAMED
- Device Name
- CPAP MASKS EUDAMED
- Model / Reference
- FM50,FM60,NM50,NM60,FM50-NV EUDAMED697385583MASK01TU EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973855830334 EUDAMED
- Basic UDI-DI
- 697385583MASK01TU EUDAMED
- EMDN Code
- R0301010201 CPAP MASKS EUDAMED
Classification
- Device Class
- Class I 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
Topsonmed, Fm60-M by Hebei Topson Medical Technology Co., Ltd. — Class I — 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 | 697385583MASK01TU | Class I | Active |
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Manufacturer
- Manufacturer
- Hebei Topson Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000024553
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (1)
- EUDAMED 3f8671cf-fbae-4ba9-a35a-48994146c3d5 61 fields · synced Jun 17, 2026