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TOPSONMED, LC-CPAP Pro
EUDAMEDClass IIa (EU MDR)
Ref LC-CPAP ProModel LC-CPAP, LC-CPAP Pro, LC-APAP, LC-APAP Pro,SS100, SS110
Identity
- Trade Name
- TOPSONMED,LC-CPAP Pro EUDAMEDTOPSONMED, LC-CPAP Pro EUDAMED
- Device Name
- Continuous Positive Airway Pressure Devices EUDAMED
- Model / Reference
- LC-CPAP, LC-CPAP Pro, LC-APAP, LC-APAP Pro,SS100, SS110 EUDAMEDLC-CPAP Pro EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973855830129 EUDAMED
- Basic UDI-DI
- 697385583CPAP01RS EUDAMEDB-06973855830129 EUDAMED
- Direct Marketing DI
- 06973855830129 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
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, LC-CPAP Pro 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 | 697385583CPAP01RS | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 697385583CPAP01RS | 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 ff4c138d-5204-4c91-9989-c68cfc29979e 61 fields · synced Jul 29, 2026
- EUDAMED 2983218c-cd5b-4b1b-84fe-1d99d6ae3695 61 fields · synced May 17, 2026