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St-Probe-7
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref ST-PROBE-7Model SENSITHERM MULTI PROBE - Esophageal temperature probe
by FIAB S.p.A.
Identity
- Trade Name
- SENSITHERM MULTI FDA UDI
- Generic Name
- Oesophageal temperature monitor probe FDA UDI
- Device Name
- ST-PROBE-7 is an esophageal lead made of an external isolating cover in medical polyurethane with a diameter of 7 French (2.3mm) and a total length of 83 cm (usable length 75 cm) that is used for monitoring the internal temperature of the esophagus. The probe is equipped with 7 steel rounded electrodes. Each electrode contains a thermocouple for the independent detection of the esophageal temperature. FDA UDI
- Model / Reference
- SENSITHERM MULTI PROBE - Esophageal temperature probe EUDAMEDST-PROBE-7 EUDAMEDFDA UDI
- Description
- ST-PROBE-7 is an esophageal lead made of an external isolating cover in medical polyurethane with a diameter of 7 French (2.3mm) and a total length of 83 cm (usable length 75 cm) that is used for monitoring the internal temperature of the esophagus. The probe is equipped with 7 steel rounded electrodes. Each electrode contains a thermocouple for the independent detection of the esophageal temperature. FDA UDI
Identifiers
- Catalog Number
- ST-PROBE-7 FDA UDI
- Primary DI / UDI-DI
- 08058480753994 EUDAMEDFDA UDI
- Basic UDI-DI
- 803300326103000007LF EUDAMED
- 510(k) Number
- K192210 FDA UDI
- FDA Product Code
- FLL FDA UDI
- EMDN Code
- V03010299 BODY TEMPERATURE MONITORING PROBES - OTHER EUDAMED
- GMDN Term
- Oesophageal temperature monitor probe 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
Yes
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
St-Probe-7 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 | 803300326103000007LF | 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 (2)
- EUDAMED c71b327c-063b-42f7-8077-3b1b81308f45 61 fields · synced Jun 20, 2026
- FDA UDI e69d4c9b-29e5-4e43-b47a-4ae442515d96 37 fields · synced May 30, 2026