Identity
- Trade Name
- UNI-T FDA UDI
- Generic Name
- Infrared patient thermometer, ear/skin FDA UDI
- Model / Reference
- UT30H FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06935750543153 FDA UDI
- 510(k) Number
- K203656 FDA UDI
- FDA Product Code
- FLL FDA UDI
- GMDN Term
- Infrared patient thermometer, ear/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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Infrared patient thermometer, ear/skin
Uni-T by Uni-Trend Technology (china) Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Infrared patient thermometer, ear/skin.
- CHOSEN Infrared Forehead Thermometer — ABOUND Diagnostics, Inc · Class II
- huangirl Infrared Thermometer — Alicn Medical Shenzhen, Inc. · Class II
- FIGHTECH — Shenzhen Urion Technology Co., Ltd. · Class II
- Infrared Thermometer — Shenzhen Pacom Medical Instruments Co., Ltd. · Class II
- Infrared Thermometer — Shenzhen Jumper Medical Equipment Co., Ltd. · Class II
- MOBI — MOBI TECHNOLOGIES, INC. · Class II
- CONAIR CORPORATION — CONAIR LLC. · Class II
- AlphaMed — Shenzhen Urion Technology Co., Ltd. · Class II
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
- Uni-Trend Technology (china) Co., Ltd.
Sources (1)
- FDA UDI abab8301-26ce-4b63-8bb9-507074995810 33 fields · synced May 31, 2026