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Topsonmed, Lc-Apap
EUDAMEDClass IIa (EU MDR)
Ref LC-APAPModel LC-CPAP, LC-CPAP Pro, LC-APAP, LC-APAP Pro,SS100, SS110
Identity
- Trade Name
- TOPSONMED,LC-APAP EUDAMEDTOPSONMED,LC- APAP EUDAMED
- Device Name
- Continuous Positive Airway Pressure Devices EUDAMED
- Model / Reference
- LC-CPAP, LC-CPAP Pro, LC-APAP, LC-APAP Pro,SS100, SS110 EUDAMEDLC-APAP EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973855830020 EUDAMED
- Basic UDI-DI
- 697385583CPAP01RS EUDAMEDB-06973855830020 EUDAMED
- Direct Marketing DI
- 06973855830020 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-Apap 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 60e3c75a-3174-44fa-95d2-aa549cc44c76 61 fields · synced Jun 18, 2026
- EUDAMED 4b3278dc-b27d-4a32-93ae-5ec8be55c10d 61 fields · synced May 19, 2026