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Positive Airway Pressure System(PAP System)
EUDAMEDClass IIa (EU MDR)
Ref RXiBreeze Ⅲ CPAPModel RXiBreeze Ⅲ CPAP, RXiBreeze Ⅲ CPAP Pro, RXiBreeze Ⅲ APAP, RXiBreeze Ⅲ APAP ProRef RXiBreeze Ⅲ APAPRef iBreeze 25STAModel iBreeze 25STA, iBreeze 30STARef iBreeze 30STRef iBreeze 30STA ProRef iBreeze 20C ProModel iBreeze 20C, iBreeze 20ARef RXiBreeze 20A PlusModel RXiBreeze 20A Plus, RXiBreeze 20C PlusRef iBreeze 25STA ProRef iBreeze 25STRef RXiBreeze 20C PlusRef iBreeze 25ARef iBreeze 20A ProRef iBreeze Tech
Identity
- Trade Name
- Positive Airway Pressure System(PAP System) EUDAMEDPositive Airway Pressure System (PAP System) EUDAMED
- Device Name
- Positive Airway Pressure System(PAP System) EUDAMEDPositive Airway Pressure System (PAP System) EUDAMED
- Model / Reference
- RXiBreeze Ⅲ CPAP, RXiBreeze Ⅲ CPAP Pro, RXiBreeze Ⅲ APAP, RXiBreeze Ⅲ APAP Pro EUDAMEDRXiBreeze Ⅲ CPAP EUDAMEDRXiBreeze Ⅲ APAP EUDAMEDiBreeze 25STA, iBreeze 30STA EUDAMEDiBreeze 25STA EUDAMEDiBreeze 30ST EUDAMEDiBreeze 30STA Pro EUDAMEDiBreeze 20C, iBreeze 20A EUDAMEDiBreeze 20C Pro EUDAMEDRXiBreeze 20A Plus, RXiBreeze 20C Plus EUDAMEDRXiBreeze 20A Plus EUDAMEDiBreeze 25STA Pro EUDAMEDiBreeze 25ST EUDAMEDRXiBreeze 20C Plus EUDAMEDiBreeze 25A EUDAMEDiBreeze 20A Pro EUDAMEDiBreeze Tech EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970819422468 EUDAMED06970819422482 EUDAMED06970819423052 EUDAMED06970819423373 EUDAMED06970819423380 EUDAMED06970819423304 EUDAMED06970819423281 EUDAMED06970819423366 EUDAMED06970819423359 EUDAMED06970819423298 EUDAMED06970819423335 EUDAMED06970819423311 EUDAMED06970819423397 EUDAMED
- Basic UDI-DI
- 697081942HR05KW EUDAMED697081942iBreeze25STAV2 EUDAMED697081942iBreeze20CZ5 EUDAMED697081942HR02KQ EUDAMED
- EMDN Code
- Z12030102 CONTINUOUS POSITIVE PRESSURE EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain EUDAMEDGermany 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
Positive Airway Pressure System(PAP System) by Resvent 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 | 697081942HR05KW | Class IIa | Active |
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Manufacturer
- Manufacturer
- Resvent Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000012608
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (13)
- EUDAMED 990601b4-6555-483b-ab62-7360d2ee758c 61 fields · synced Jul 30, 2026
- EUDAMED 498c01e1-bb06-4e68-855d-d7afd7ac7c29 61 fields · synced May 17, 2026
- EUDAMED 08490ffe-132d-43ef-bd22-382cb59fa304 61 fields · synced May 18, 2026
- EUDAMED d6907dba-d7ba-43f6-ab22-65d798339dbf 61 fields · synced Jun 18, 2026
- EUDAMED fa8de370-1ad7-4a8c-aad4-6a140d220662 61 fields · synced Jul 9, 2026
- EUDAMED 7db67591-cb08-4c16-b572-4098add10d18 61 fields · synced Jul 11, 2026
- EUDAMED 66a074b5-d7d5-4c88-ab7c-2d95414c611b 61 fields · synced Jul 11, 2026
- EUDAMED 9d3a3b18-ac41-4539-a3f9-de48cc3388e0 61 fields · synced Jul 12, 2026
- EUDAMED 297a43b6-b74a-4737-b289-c2905af2335a 61 fields · synced Jul 13, 2026
- EUDAMED 1f7239d3-b29d-4bce-947e-11c72f943578 61 fields · synced Jul 16, 2026
- EUDAMED 5dce04d3-07b8-4c5c-b6b5-3aee715eeef4 61 fields · synced Jul 24, 2026
- EUDAMED b5194ac6-e7a9-4cc0-b30c-6dbb27314997 61 fields · synced Jul 29, 2026
- EUDAMED ae4d152b-936a-44d0-b696-c3021de33fd8 61 fields · synced Jul 30, 2026