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BiPAP A40 Pro Titration Rental Program IN
EUDAMEDClass IIb (EU MDR)
Ref RINX3100S19
Identity
- Trade Name
- BiPAP A40 Pro Titration Rental Program IN EUDAMED
- Device Name
- BiPAP A40 Pro Titration Rental Program IN EUDAMED
- Model / Reference
- RINX3100S19 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00606959422544 EUDAMED
- Basic UDI-DI
- B-00606959422544 EUDAMED
- EMDN Code
- Z12030103 PULMONARY VENTILATORS FOR NON–HOSPITAL USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany 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
BiPAP A40 Pro Titration Rental Program IN 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-00606959422544 | 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 (1)
- EUDAMED de43343e-109a-4d1e-a779-6c0ee397ddda 61 fields · synced Aug 1, 2026