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BiPAP autoSV ADV, 60 Srs, 30cm, DE Rental
EUDAMEDClass IIb (EU MDR)
Ref RDE962SModel BiPAP autoSV Advanced System One
Identity
- Trade Name
- BiPAP autoSV ADV,60 Srs, 30cm, DE Rental EUDAMED
- Model / Reference
- BiPAP autoSV Advanced System One EUDAMEDRDE962S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00606959410046 EUDAMED
- Basic UDI-DI
- B-00606959410046 EUDAMED
- EMDN Code
- Z12030102 CONTINUOUS POSITIVE PRESSURE EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
BiPAP autoSV ADV, 60 Srs, 30cm, DE Rental by Respironics, Inc. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00606959410046 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Respironics Inc.
- EUDAMED SRN
- US-MF-000002301
- Authorised Representative
- Respironics Deutschland GmbH & Co.KG DE-AR-000006164
Sources (2)
- EUDAMED e003d9d4-5439-4719-bc87-44b41bc60d59 61 fields · synced Jul 10, 2026
- EUDAMED 635b10c2-9f71-4a7e-bd77-4a648ac79ff9 61 fields · synced Jul 10, 2026