Identity
- Trade Name
- TOPSONMED, LC-BPAP-30T EUDAMED
- Device Name
- Continuous Positive Airway Pressure Devices EUDAMED
- Model / Reference
- BPAP EUDAMEDLC-BPAP-30T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973855830068 EUDAMED
- Basic UDI-DI
- 697385583BPAP01RD EUDAMEDB-06973855830068 EUDAMED
- Direct Marketing DI
- 06973855830068 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, Lc-Bpap-30t by Hebei Topson Medical Technology Co., Ltd. — Class IIa — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 697385583BPAP01RD | Class IIa | Active |
| 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 (2)
- EUDAMED 50937a94-1d62-496f-bed7-ef5dfe38074c 61 fields · synced Jul 27, 2026
- EUDAMED 90fe7972-8ebc-4f50-81e5-5939e98139ca 61 fields · synced May 17, 2026