Identity
- Trade Name
- TOPSONMED, SS150 EUDAMED
- Device Name
- Continuous Positive Airway Pressure Devices EUDAMED
- Model / Reference
- BPAP EUDAMEDSS150 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973855830563 EUDAMED
- Basic UDI-DI
- 697385583BPAP01RD EUDAMED
- Direct Marketing DI
- 06973855830563 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, Ss150 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hebei Topson Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000024553
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (1)
- EUDAMED 29579946-bcb0-4e42-9aeb-4c215a21e6a4 61 fields · synced Aug 2, 2026