TekCare Non-Contact Infrared Thermometer
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Non-Contact Infrared Thermometer EUDAMEDTekCare Non-Contact Infrared Thermometer FDA UDI
- Generic Name
- Infrared patient thermometer, ear FDA UDI
- Device Name
- Touch Free Infrared Thermometer EUDAMEDThe NT19 thermometer is designed for the intermittent measurement of the human body's temperature in the domestic environment and can be used upon people of all ages FDA UDI
- Model / Reference
- NT19 EUDAMEDFDA UDI3106445000 EUDAMEDNon-Contact Infrared Thermometer EUDAMED
- Description
- The NT19 thermometer is designed for the intermittent measurement of the human body's temperature in the domestic environment and can be used upon people of all ages FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04710953426371 EUDAMED04710953426395 EUDAMED04710953421598 FDA UDI
- Basic UDI-DI
- 471095342TCF03NTXM2 EUDAMED
- Direct Marketing DI
- 04710953426371 EUDAMED04710953426395 EUDAMED
- FDA Product Code
- FLL FDA UDI
- EMDN Code
- V0301010202 NON-CONTACT DIGITAL THERMOMETERS EUDAMED
- GMDN Term
- Infrared patient thermometer, ear FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.2910 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
Yes
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Infrared patient thermometer, ear
TekCare Non-Contact Infrared Thermometer by Avita Corporation — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Infrared patient thermometer, ear.
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Avita Corporation
Sources (3)
- FDA UDI 9b5b2682-d74c-41d0-b41c-9eea079d12ef 34 fields · synced Jul 15, 2026
- EUDAMED a53cea49-79c8-4873-b5f3-8faf1f8a65b0 61 fields · synced Jul 10, 2026
- EUDAMED 1ac41c19-1a86-46cb-9d79-8f3d490184fb 61 fields · synced Jul 15, 2026