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ALICE PDX Portable Sleep Diagnostic System International
EUDAMEDClass IIa (EU MDR)
Ref RBR1043844
Identity
- Trade Name
- ALICE PDX Portable Sleep Diagnostic System International EUDAMED
- Device Name
- Alice PDx System EUDAMED
- Model / Reference
- RBR1043844 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00606959406810 EUDAMED
- Basic UDI-DI
- B-00606959406810 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 Portable Sleep Diagnostic System International 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-00606959406810 | 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 040fb479-9bc6-468c-85a8-9e0aed5c6bd8 61 fields · synced Jun 19, 2026
- EUDAMED 263b693f-d8bf-4ace-afb8-14aa453357f6 61 fields · synced Jun 19, 2026