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Cable, ExG Yoke, Alice PDx, Intl. Rental
EUDAMEDClass IIa (EU MDR)
Ref RBR1048415Model Alice PDx
Identity
- Trade Name
- Cable, ExG Yoke, Alice PDx, Intl. Rental EUDAMED
- Model / Reference
- Alice PDx EUDAMEDRBR1048415 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00606959406841 EUDAMED
- Basic UDI-DI
- B-00606959406841 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Cable, ExG Yoke, Alice PDx, Intl. 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-00606959406841 | 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 b0a17e59-3638-4ef5-8273-e2ed544ab31d 61 fields · synced Jun 20, 2026
- EUDAMED 5dd9ea62-1eb0-4d35-a5d7-11b437c62a1a 61 fields · synced Jun 20, 2026