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Positive Airway Pressure System(PAP System)
EUDAMEDClass IIa (EU MDR)
Ref iBreeze 30STAModel iBreeze 25STA, iBreeze 30STA
Identity
- Trade Name
- Positive Airway Pressure System(PAP System) EUDAMED
- Device Name
- Positive Airway Pressure System(PAP System) EUDAMED
- Model / Reference
- iBreeze 25STA, iBreeze 30STA EUDAMEDiBreeze 30STA EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970819423069 EUDAMED
- Basic UDI-DI
- 697081942iBreeze25STAV2 EUDAMED
- EMDN Code
- Z12030102 CONTINUOUS POSITIVE PRESSURE EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain 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 | 697081942iBreeze25STAV2 | 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 (1)
- EUDAMED 2daf35c3-a29c-4560-bd3b-ecf04371afdb 61 fields · synced Jun 18, 2026