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St-Monitor
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref ST-MONITORModel SENSITHERM MULTI MONITOR - Clinical programmable esophageal temperature monitor
by FIAB S.p.A.
Identity
- Trade Name
- SENSITHERM MULITI FDA UDI
- Generic Name
- Oesophageal temperature monitor FDA UDI
- Device Name
- ST-MONITOR is a device for monitoring of esophageal temperature on three different points; moreover it allows setting of temperature threshold alarm value between 36°C and 41°C. ST-MONITOR is equipped with three high precision thermometers to be connected, through an appropriate cable and connector, to the ST-PROBE. Using this device it is possible to follow, in immediate and precise way, the rise of the temperature inside the esophagous. The incorporated alarm system allows to the operator to set an adequate threshold temperature. A buzzer and a flashing led signal the exceeding the temperatures of the threshold value alarm, the temperature and alarm signals can be sent to an external display and recording system through output signal connector. Sensitherm Multi System is intended for continue esophageal temperature monitoring and it consists of 3 components: ST-MONITOR, Patient Cable (ST-PTCBL model number) and Probe (ST-PROBE model number). FDA UDI
- Model / Reference
- SENSITHERM MULTI MONITOR - Clinical programmable esophageal temperature monitor EUDAMEDST-MONITOR EUDAMEDFDA UDI
- Description
- ST-MONITOR is a device for monitoring of esophageal temperature on three different points; moreover it allows setting of temperature threshold alarm value between 36°C and 41°C. ST-MONITOR is equipped with three high precision thermometers to be connected, through an appropriate cable and connector, to the ST-PROBE. Using this device it is possible to follow, in immediate and precise way, the rise of the temperature inside the esophagous. The incorporated alarm system allows to the operator to set an adequate threshold temperature. A buzzer and a flashing led signal the exceeding the temperatures of the threshold value alarm, the temperature and alarm signals can be sent to an external display and recording system through output signal connector. Sensitherm Multi System is intended for continue esophageal temperature monitoring and it consists of 3 components: ST-MONITOR, Patient Cable (ST-PTCBL model number) and Probe (ST-PROBE model number). FDA UDI
Identifiers
- Catalog Number
- ST-MONITOR FDA UDI
- Primary DI / UDI-DI
- 08058480754021 EUDAMEDFDA UDI08054953340197 EUDAMED08058480757602 EUDAMED
- Basic UDI-DI
- 803300326103000003L7 EUDAMED
- Direct Marketing DI
- 08058480754021 EUDAMED08054953340197 EUDAMED08058480757602 EUDAMED
- 510(k) Number
- K192210 FDA UDI
- FDA Product Code
- FLL FDA UDI
- EMDN Code
- V030199 BODY TEMPERATURE MEASURING DEVICES - OTHER EUDAMED
- GMDN Term
- Oesophageal temperature monitor FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 880.2910 FDA UDI
- Market of Registration
- Italy 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
St-Monitor by FIAB S.p.A. — Class IIb — 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 | 803300326103000003L7 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- FIAB S.p.A.
- EUDAMED SRN
- IT-MF-000005988
Sources (4)
- EUDAMED fcaaefa9-ee84-4dab-b522-415692f89850 61 fields · synced Oct 6, 2026
- EUDAMED d0c3d485-497b-4c7d-9d37-a8ec73cdcfb2 61 fields · synced May 16, 2026
- EUDAMED db6669a1-4e62-4ea5-b9d2-6b90a22d5fbc 61 fields · synced May 17, 2026
- FDA UDI 21d244fb-9c1e-46e9-9beb-73ae8d7f246e 37 fields · synced May 30, 2026