← Back to catalogue
Alice NightOne System Intl, Wireless, Rental
EUDAMEDClass IIa (EU MDR)
Ref R1114801
Identity
- Trade Name
- Alice NightOne System Intl, Wireless, Rental EUDAMED
- Device Name
- Alice NightOne System EUDAMED
- Model / Reference
- R1114801 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00606959407640 EUDAMED
- Basic UDI-DI
- B-00606959407640 EUDAMED
- EMDN Code
- Z12100501 POLYSOMNOGRAPHS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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 NightOne System Intl, Wireless, 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-00606959407640 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Respironics Inc.
- EUDAMED SRN
- US-MF-000002301
- Authorised Representative
- Respironics Deutschland GmbH & Co.KG DE-AR-000006164
Sources (2)
- EUDAMED 786febbb-fe53-4887-8830-d00d349d80d6 61 fields · synced Jul 31, 2026
- EUDAMED 0bc56a34-d6da-4caa-b377-cd4234e4e43c 61 fields · synced Jul 31, 2026