Identity
- Trade Name
- TOPSONMED, SS170 EUDAMED
- Device Name
- Continuous Positive Airway Pressure Devices EUDAMED
- Model / Reference
- BPAP EUDAMEDSS170 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973855830587 EUDAMED
- Basic UDI-DI
- 697385583BPAP01RD EUDAMED
- Direct Marketing DI
- 06973855830587 EUDAMED
- EMDN Code
- Z12030102 CONTINUOUS POSITIVE PRESSURE EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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, Ss170 by Hebei Topson Medical Technology 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 | 697385583BPAP01RD | Class IIa | 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 6e2be7ea-8457-4d49-853f-67e0ee54f024 61 fields · synced Jun 19, 2026