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Thermistor, Oral, Alice PDx Recertified
EUDAMEDClass I (EU MDR)
Ref UP1379Model Thermistor Airflow Sensor
Identity
- Trade Name
- Thermistor, Oral, Alice PDx Recertified EUDAMED
- Model / Reference
- Thermistor Airflow Sensor EUDAMEDUP1379 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00606959406780 EUDAMED
- Basic UDI-DI
- B-00606959406780 EUDAMED
- EMDN Code
- Z12100580 POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I 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
Thermistor, Oral, Alice PDx Recertified by Pro-Tech Services, Inc. — Class I — 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-00606959406780 | Class I | Active |
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Manufacturer
- Manufacturer
- Pro-Tech Services, Inc.
- EUDAMED SRN
- US-MF-000002300
- Authorised Representative
- Respironics Deutschland GmbH & Co.KG DE-AR-000006164
Sources (2)
- EUDAMED b47af3c9-2ee9-4cc2-b83c-a6d14838f6d4 61 fields · synced Jul 16, 2026
- EUDAMED f34562f4-e2f2-47a0-bcab-1e43858d3738 61 fields · synced Jul 16, 2026