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ResFree Series Positive Airway Pressure Devices
EUDAMEDClass IIa (EU MDR)
Ref R-20iModel R-20C; R-20A; R-20i; F-20C;F-20A; F-20i;
Identity
- Trade Name
- ResFree Series Positive Airway Pressure Devices EUDAMED
- Device Name
- Positive Airway Pressure Devices EUDAMED
- Model / Reference
- R-20C; R-20A; R-20i; F-20C;F-20A; F-20i; EUDAMEDR-20i EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06958949927312 EUDAMED
- Basic UDI-DI
- 6958949943265 EUDAMED
- Direct Marketing DI
- 06958949927312 EUDAMED
- EMDN Code
- Z12030102 CONTINUOUS POSITIVE PRESSURE EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Northern Ireland 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
ResFree Series Positive Airway Pressure Devices by Hunan Beyond Medical Technology Co., Ltd. — Class IIa — MDR — listed in EUDAMED
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 | 6958949943265 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Hunan Beyond Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000002143
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (1)
- EUDAMED bb08a16b-53e6-4460-a47e-f6a6bc2353cc 61 fields · synced Jun 19, 2026