Identity
- Trade Name
- Alice Night One, Wireless, Ukraine EUDAMED
- Device Name
- Alice NightOne System EUDAMED
- Model / Reference
- UA1114801 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00606959058446 EUDAMED
- Basic UDI-DI
- B-00606959058446 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 Night One, Wireless, Ukraine 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-00606959058446 | 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 ab07b48e-674f-4860-b82b-129b2ec91e37 61 fields · synced Jun 19, 2026
- EUDAMED 6af90bd9-1bb2-4fc8-a3f4-62055bfcb0e9 61 fields · synced Jun 19, 2026