Identity
- Trade Name
- Alice NightOne, Nonin SpO2 Cable EUDAMEDAlice NightOne FDA UDI
- Generic Name
- Polysomnography analyser FDA UDI
- Device Name
- Alice NightOne System EUDAMEDAlice NightOne Nonin SpO2 Cable FDA UDI
- Model / Reference
- 1119823 EUDAMEDAlice NightOne, Nonin SpO2 Cable FDA UDI
- Description
- Alice NightOne Nonin SpO2 Cable FDA UDI
Identifiers
- Catalog Number
- 1119823 FDA UDI
- Primary DI / UDI-DI
- 00606959039728 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00606959039728 EUDAMED
- 510(k) Number
- K083874 FDA UDI
- FDA Product Code
- MNR FDA UDI
- EMDN Code
- C900301,Z12100501 EUDAMED
- GMDN Term
- Polysomnography analyser FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 868.2375 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Alice NightOne, Nonin SpO2 Cable by Respironics, Inc. — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00606959039728 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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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 926af22b-74bf-487a-8a8f-400fdfc6a957 61 fields · synced Jun 18, 2026
- FDA UDI 75a332bc-ceb9-4a5f-a262-300c84e27a91 37 fields · synced May 30, 2026