Identity
- Trade Name
- Non-contact Infrared Thermometer DT-100 FDA UDI
- Generic Name
- Infrared patient thermometer, skin FDA UDI
- Device Name
- The DT-100 non-contact infrared thermometer is intended to be used to measure temperature for consumers including adult, pediatric and neonatal using infrared sensors. It can detect the body temperature from human's face. The DT-100 infrared thermometer can be used by consumers in household environment. FDA UDI
- Model / Reference
- DT-100 FDA UDI
- Description
- The DT-100 non-contact infrared thermometer is intended to be used to measure temperature for consumers including adult, pediatric and neonatal using infrared sensors. It can detect the body temperature from human's face. The DT-100 infrared thermometer can be used by consumers in household environment. FDA UDI
Identifiers
- Catalog Number
- 00885 FDA UDI
- Primary DI / UDI-DI
- 18800003445537 FDA UDI
- 510(k) Number
- K160358 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Infrared patient thermometer, skin
Non-contact Infrared Thermometer DT-100 by Mediana.CO.LTD — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Mediana.CO.LTD
Sources (1)
- FDA UDI 47d050f2-5fc7-4bdb-b730-f7412a2e9421 35 fields · synced Jun 6, 2026