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TOUCH FREE Infrared Thermometer
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref NT16BModel 02009197100000Model 00009222000000Ref NT1BRef NT19Ref NT17Ref NT16Model 3106445000
Identity
- Trade Name
- Touch Free Infrared Thermometer EUDAMEDAdtemp™ FDA UDI
- Generic Name
- Infrared patient thermometer, skin FDA UDI
- Device Name
- TOUCH FREE Infrared Thermometer EUDAMEDADTEMP 429 Non-Contact Thermometer, 1 second FDA UDI
- Model / Reference
- 02009197100000 EUDAMEDNT16B EUDAMED00009222000000 EUDAMEDNT1B EUDAMEDNT19 EUDAMEDNT17 EUDAMED3106445000 EUDAMEDNT16 EUDAMED429 FDA UDI
- Description
- ADTEMP 429 Non-Contact Thermometer, 1 second FDA UDI
Identifiers
- Catalog Number
- 429 FDA UDI
- Primary DI / UDI-DI
- 04710953422564 EUDAMED04710953422571 EUDAMED04710953422656 EUDAMED04710953423998 EUDAMED00634782083472 EUDAMEDFDA UDI04710953425503 EUDAMED
- Basic UDI-DI
- B-04710953422564 EUDAMEDB-04710953422571 EUDAMEDB-04710953422656 EUDAMEDB-04710953423998 EUDAMEDB-04710953425503 EUDAMED471095342TCF03NTXM2 EUDAMED
- Direct Marketing DI
- 00634782083472 EUDAMED
- 510(k) Number
- K081160 FDA UDI
- FDA Product Code
- FLL FDA UDI
- EMDN Code
- V03010201 TEMPERATURE MONITORING CUTANEOUS PROBES EUDAMEDV0301010202 NON-CONTACT DIGITAL THERMOMETERS EUDAMED
- GMDN Term
- Infrared patient thermometer, skin FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.2910 FDA UDI
- Market of Registration
- Italy EUDAMEDRomania EUDAMEDFrance EUDAMEDIreland 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
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
Yes
EUDAMEDEUDAMED
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: General-purpose patient temperature probe, reusable
TOUCH FREE Infrared Thermometer by Avita Corporation — Class IIa — MDR, 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/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-04710953422564 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-04710953422564 | 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 (7)
- EUDAMED 2267d54d-9f08-49c7-8498-016d0cbd77c6 61 fields · synced Aug 3, 2026
- EUDAMED 9614aadb-97cd-445f-a389-5de015f37cec 61 fields · synced May 17, 2026
- EUDAMED 2d049c41-d4ac-4412-8462-f685da1e665f 61 fields · synced May 17, 2026
- EUDAMED aadbfe43-deb5-4987-b77a-5efca712ef03 61 fields · synced May 18, 2026
- FDA UDI c25dbeaf-be7a-4227-beb1-6c13b683969f 37 fields · synced May 29, 2026
- EUDAMED aa1f89c3-e467-4eac-a635-178403aa2bfd 61 fields · synced Jul 16, 2026
- EUDAMED ba97649d-9060-4a02-884d-6ce37aa6181d 61 fields · synced Jul 19, 2026