Identity
- Trade Name
- THERMOFINDER FDA UDI
- Generic Name
- Infrared patient thermometer, skin FDA UDI
- Device Name
- The Non-Contact Infrared Thermometer is an electronic thermometer using an infrared sensor (thermopile) to measure forehead temperature. Its operation is based on measuring the natural thermal radiation emanating from the forehead and the adjacent surfaces. Its software performs a calculation that factors in room temperature, and then a calculated temperature is displayed on the LCD. FDA UDI
- Model / Reference
- FS-300 FDA UDI
- Description
- The Non-Contact Infrared Thermometer is an electronic thermometer using an infrared sensor (thermopile) to measure forehead temperature. Its operation is based on measuring the natural thermal radiation emanating from the forehead and the adjacent surfaces. Its software performs a calculation that factors in room temperature, and then a calculated temperature is displayed on the LCD. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800132200161 FDA UDI
- 510(k) Number
- K130361 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
- 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Infrared patient thermometer, skin
Thermofinder by HuBDIC Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Infrared patient thermometer, skin.
- TytoHome — TYTO CARE LTD · Class II
- ALPHAMED — Shenzhen Urion Technology Co., Ltd. · Class II
- Diagnostix™ — American Diagnostic Corporation · Class II
- Famidoc — FAMIDOC USA, INC. · Class II
- Sinocare Non-contact Infrared Thermometer — Alicn Medical Shenzhen, Inc. · Class II
- Famidoc — Famidoc Technology Company Limited · Class II
- DR.TALBOT'S Non-contact Infrared Thermometer — Alicn Medical Shenzhen, Inc. · Class II
- Berrcom — Guangzhou Berrcom Medical Device Co., Ltd · Class II
Cleared under the same submission
K130361 also covers:
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
- HuBDIC Co., Ltd.
Sources (1)
- FDA UDI 3f1baeec-66e3-4514-afae-930772aee329 35 fields · synced May 30, 2026