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ALICE PDx Diagnostic System International, Rental
EUDAMEDClass IIa (EU MDR)
Ref R1043844
Identity
- Trade Name
- ALICE PDx Diagnostic System International, Rental EUDAMED
- Device Name
- Alice PDx System EUDAMED
- Model / Reference
- R1043844 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00606959406711 EUDAMED
- Basic UDI-DI
- B-00606959406711 EUDAMED
- EMDN Code
- Z12100501 POLYSOMNOGRAPHS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria 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
ALICE PDx Diagnostic System International, Rental by Respironics, Inc. — Class IIa — 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-00606959406711 | Class IIa | 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 b88974ea-590e-4b4e-b9bd-916861764563 61 fields · synced Jul 9, 2026
- EUDAMED 1d7d1429-bb17-492c-9765-6d8eec4d5537 61 fields · synced Jul 9, 2026