Identity
- Trade Name
- Tecnimed - Handi-Craft Company FDA UDI
- Generic Name
- Infrared patient thermometer, skin FDA UDI
- Device Name
- Infrared thermometer intended for intermittent measurement of human body temperature in people of all ages. Measurement site: forehead (without contact). FDA UDI
- Model / Reference
- VisioFocus SMART FDA UDI
- Description
- Infrared thermometer intended for intermittent measurement of human body temperature in people of all ages. Measurement site: forehead (without contact). FDA UDI
Identifiers
- Catalog Number
- 06470 FDA UDI
- Primary DI / UDI-DI
- 00182097000238 FDA UDI
- FDA Product Code
- FLL FDA UDI
- GMDN Term
- Infrared patient thermometer, skin FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.2910 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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
Yes
FDA UDI
Tecnimed - Handi-Craft Company by Tecnimed Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Tecnimed Srl
Sources (1)
- FDA UDI 9721f8bf-7192-4645-ba04-16b0efffbc7d 36 fields · synced May 30, 2026