← Back to catalogue
Alice LE System INTL
EUDAMEDClass IIa (EU MDR)
Ref 1002288Model Alice 5 and Alice LE Polysomnography Systems
Identity
- Trade Name
- Alice LE System INTL EUDAMED
- Model / Reference
- Alice 5 and Alice LE Polysomnography Systems EUDAMED1002288 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00606959020245 EUDAMED
- Basic UDI-DI
- B-00606959020245 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Alice LE System INTL 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-00606959020245 | 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 (1)
- EUDAMED df4344e6-edf4-447b-a960-8d4dddf91e4b 61 fields · synced Jun 17, 2026