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Infrared Thermometer
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref YK-IRT3Ref YK-IRT4
Identity
- Trade Name
- Infrared Thermometer EUDAMED
- Device Name
- Infrared Thermometer EUDAMED
- Model / Reference
- YK-IRT3 EUDAMEDYK-IRT4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06921745203034 EUDAMED06921745200415 EUDAMED06921745203041 EUDAMED
- Basic UDI-DI
- B-06921745203034 EUDAMED69217452IRTFUJ EUDAMEDB-06921745203041 EUDAMED
- Direct Marketing DI
- 06921745200415 EUDAMED
- EMDN Code
- V0301010202 NON-CONTACT DIGITAL THERMOMETERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Infrared Thermometer by Xuzhou Yongkang Electronic Science Technology Co., Ltd — Class IIa — FDA_510K, MDR, MDD — listed in EUDAMED, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K180314 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | B-06921745203034 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06921745203034 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000018890
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (4)
- EUDAMED f1916f06-522a-494f-bc67-9d7374bcb60b 61 fields · synced Oct 6, 2026
- EUDAMED b814ca29-3738-44e4-aa44-a60dd232675e 61 fields · synced May 18, 2026
- EUDAMED 7b121601-3ecb-4c9f-a577-0d3414b55e5e 61 fields · synced May 19, 2026
- FDA 510(k) K180314 1 fields · synced May 18, 2026