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Alice PDx Unit Only, Warranty Exchange, INTL
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 1057624
Identity
- Trade Name
- Alice PDx Unit Only, Warranty Exchange, INTL EUDAMEDAlice PDx FDA UDI
- Generic Name
- Polysomnograph FDA UDI
- Device Name
- Alice PDx System EUDAMEDAlice PDx Unit Only, Warranty Exchange, International FDA UDI
- Model / Reference
- 1057624 EUDAMEDAlice PDx Unit Only, Warranty Exchange, INTL FDA UDI
- Description
- Alice PDx Unit Only, Warranty Exchange, International FDA UDI
Identifiers
- Catalog Number
- 1057624 FDA UDI
- Primary DI / UDI-DI
- 00606959020689 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00606959020689 EUDAMED
- 510(k) Number
- K090484 FDA UDI
- FDA Product Code
- MNR FDA UDI
- EMDN Code
- Z12100501 POLYSOMNOGRAPHS EUDAMED
- GMDN Term
- Polysomnograph FDA UDI
Classification
- Device Class
- Class IIa 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 PDx Unit Only, Warranty Exchange, INTL by Respironics, Inc. — Class IIa — 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-00606959020689 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 (3)
- EUDAMED 515b875a-46ba-483f-9a92-027b153eb9b4 61 fields · synced Jun 19, 2026
- FDA UDI ee90f0ca-ed76-415b-9eb2-dd5f19621485 37 fields · synced May 29, 2026
- EUDAMED 128f98ce-d484-405b-8c88-c870af98c428 61 fields · synced Jun 19, 2026