Identity
- Trade Name
- AViTA EUDAMEDTekCare Touch Free Infrared Thermometer FDA UDI
- Generic Name
- Infrared patient thermometer, ear FDA UDI
- Device Name
- TOUCH FREE Infrared Thermometer EUDAMEDThe NT17 THERMO DISTANCE 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
- NT17 EUDAMEDFDA UDI
- Description
- The NT17 THERMO DISTANCE 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
- 04710953422588 EUDAMED04710953421512 FDA UDI
- Basic UDI-DI
- B-04710953422588 EUDAMED
- FDA Product Code
- FLL FDA UDI
- EMDN Code
- V03010201 TEMPERATURE MONITORING CUTANEOUS PROBES 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
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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: General-purpose patient temperature probe, reusable
AViTA by Avita Corporation — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04710953422588 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- AViTA Corporation
- EUDAMED SRN
- TW-MF-000010455
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED be0febee-c3d6-4c16-91fc-017c050c8f77 61 fields · synced Jun 8, 2026
- FDA UDI 60d81bed-6d15-463d-938b-a9050186608e 34 fields · synced May 25, 2026