Identity
- Trade Name
- FDK FDA UDI
- Generic Name
- Infrared patient thermometer, skin FDA UDI
- Device Name
- FDK NON-CONTACT INFRARED THERMOMETER FDA UDI
- Model / Reference
- FT-F31 FDA UDI
- Description
- FDK NON-CONTACT INFRARED THERMOMETER FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00859020006062 FDA UDI
- 510(k) Number
- K111703 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
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Infrared patient thermometer, skin
Fdk by Fudakang Industrial 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
K111703 also covers:
- Advocate Non-Contact Infra-red thermometer — DIABETIC SUPPLY OF SUNCOAST, INC.
- AUPO — Fudakang Industrial Co., Ltd.
- FDK — Fudakang Industrial Co., Ltd.
- FDK — Fudakang Industrial Co., Ltd.
- FDK — Fudakang Industrial Co., Ltd.
- FDK — Fudakang Industrial Co., Ltd.
- FDK — Fudakang Industrial Co., Ltd.
- FDK — Fudakang Industrial Co., Ltd.
- FDK — Fudakang Industrial Co., Ltd.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Fudakang Industrial Co., Ltd.
Sources (1)
- FDA UDI 68172c79-30df-42e8-abca-a70d524c3db0 34 fields · synced Jun 1, 2026