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Alice PDx Core System without Sensors, INTL
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 1058370
Identity
- Trade Name
- Alice PDx Core System without Sensors, INTL EUDAMEDAlice PDx FDA UDI
- Generic Name
- Polysomnograph FDA UDI
- Device Name
- Alice PDx System EUDAMEDAlice PDx Core System, without Sensors, International FDA UDI
- Model / Reference
- 1058370 EUDAMEDAlice PDx Core System without Sensors, INTL FDA UDI
- Description
- Alice PDx Core System, without Sensors, International FDA UDI
Identifiers
- Catalog Number
- 1058370 FDA UDI
- Primary DI / UDI-DI
- 00606959039025 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00606959039025 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 Core System without Sensors, 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-00606959039025 | 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 d0dee1dc-2fe2-44bc-9f6a-37e3e4528792 61 fields · synced Jun 18, 2026
- FDA UDI 5fbd4261-677a-4912-825f-32c1ff748215 37 fields · synced May 30, 2026
- EUDAMED bab5eadf-bd20-410b-8581-f82ba4a900e6 61 fields · synced Jun 18, 2026