Infrared Forehead Thermometer FT-100A
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Device Name
- Infrared Thermometer EUDAMED
- Model / Reference
- FT-100C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06949395046177 EUDAMED
- Basic UDI-DI
- B-06949395046177 EUDAMED
- 510(k) Number
- K160802 FDA 510(k)
- FDA Product Code
- FLL FDA 510(k)
- EMDN Code
- V0301010202 NON-CONTACT DIGITAL THERMOMETERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.2910 FDA 510(k)
- Regulation Number
- 880.2910 FDA 510(k)
- Market of Registration
- Türkiye EUDAMED
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
The Infrared Forehead Thermometer FT-100A is a non-contact, infrared thermometer designed to measure core body temperature via the forehead. It utilises thermal imaging technology to provide rapid, accurate readings without physical contact, making it suitable for clinical and home use in assessing fever or hypothermia in patients of all ages.
This device is intended for single-use or reusable applications in general hospital settings, depending on manufacturer guidelines. Supplied sterile or non-sterile as specified, it adheres to FDA 510(k) clearance (K160802) and EU regulatory standards (MDD, MDR). The FT-100A is classified under product code FLL and must be stored according to manufacturer instructions to maintain accuracy and functionality.
Frequently asked questions
Can this thermometer be used on patients of all ages, including newborns and infants?
Yes, the FT-100A is designed for measuring core body temperature in patients of all ages, including newborns and infants. Its non-contact infrared technology allows for quick and accurate readings without physical contact, which is particularly useful for vulnerable populations where traditional methods may be impractical or uncomfortable.
How is the FT-100A supplied, and can it be reused?
The FT-100A is supplied either sterile or non-sterile, depending on the specific order or manufacturer guidelines. It is intended for single-use or reusable applications in clinical settings, so whether reuse is permitted depends on adherence to the manufacturer’s cleaning and sterilization protocols. Always follow the manufacturer’s instructions to ensure accuracy and safety.
What storage conditions are required to maintain the device’s accuracy and functionality?
The FT-100A must be stored according to the manufacturer’s instructions to preserve its performance. While the exact conditions aren’t detailed here, typical infrared thermometers require protection from extreme temperatures, humidity, and physical damage. Avoid exposure to direct sunlight or moisture, and store in a clean, dry environment as recommended by Hangzhou Universal Electronic Co., Ltd.
Is this device approved for use in both clinical and home settings?
Yes, the FT-100A is designed for clinical and home use to assess fever or hypothermia. Its non-contact design makes it practical for quick temperature checks in both environments. However, for clinical use, adherence to sterile or non-sterile specifications (as specified by the manufacturer) is critical, especially in hospital settings.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K160802 | Class II | Active |
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Manufacturer
- Manufacturer
- Hangzhou Universal Electronic Co., Ltd.
Sources (2)
- FDA 510(k) K160802 24 fields · synced Sep 18, 2026
- EUDAMED ab34232b-9467-4430-9cd0-8c3b4d9aef30 61 fields · synced Jul 9, 2026