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Nasal/Oral Flow Sensor Thermistor
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref SEN599TModel Thermistor
Identity
- Trade Name
- Nasal/Oral Flow Sensor Thermistor EUDAMEDSOMNOscreen plus accessory FDA UDI
- Generic Name
- Polysomnograph FDA UDI
- Model / Reference
- Thermistor EUDAMEDSEN599T EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04250413400560 EUDAMEDFDA UDI
- Basic UDI-DI
- 42504134ThermistorPT EUDAMED
- 510(k) Number
- K081485 FDA UDI
- FDA Product Code
- MNR FDA UDI
- EMDN Code
- Z1203020280 MULTI-PARAMETER MONITORS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Polysomnograph FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.2375 FDA UDI
- Market of Registration
- Germany 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Nasal/Oral Flow Sensor Thermistor by SOMNOmedics AG — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 42504134ThermistorPT | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- SOMNOmedics AG
- EUDAMED SRN
- DE-MF-000006921
Sources (2)
- EUDAMED ff0ccb14-243e-48ec-bb3c-87cf25383428 61 fields · synced Jul 9, 2026
- FDA UDI dec46bf7-94a1-4bec-8142-5ab95e930f39 33 fields · synced May 30, 2026