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Infrared Forehead Thermometer
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref TL20230804Model JA-11C
Identity
- Trade Name
- Infrared Forehead Thermometer EUDAMEDYASEE FDA UDI
- Generic Name
- Infrared patient thermometer, skin FDA UDI
- Device Name
- Infrared Forehead Thermometer EUDAMEDInfrared Forehead Thermometer is hand-held, battery powered, Infrared Forehead Thermometers that covert a user’s forehead temperature, using the infrared energy emitted in the area around the user’s forehead to an equivalent temperature when measuring from 1-3 cm of the subject’s forehead with no contact. FDA UDI
- Model / Reference
- JA-11C EUDAMEDFDA UDITL20230804 EUDAMED
- Description
- Infrared Forehead Thermometer is hand-held, battery powered, Infrared Forehead Thermometers that covert a user’s forehead temperature, using the infrared energy emitted in the area around the user’s forehead to an equivalent temperature when measuring from 1-3 cm of the subject’s forehead with no contact. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06972359493113 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06972359493113 EUDAMED
- 510(k) Number
- K220084 FDA UDI
- FDA Product Code
- FLL FDA UDI
- EMDN Code
- V0301010202 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 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
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Infrared Forehead Thermometer by Qingdao Yasee Medical Device Co., Ltd — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K220084 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06972359493113 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Qingdao Yasee Medical Device Co., Ltd.
- EUDAMED SRN
- CN-MF-000037591
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (3)
- EUDAMED e60da512-7756-4ed3-899a-40094f4aba0f 61 fields · synced Jun 18, 2026
- FDA UDI 615297e5-3e06-4031-a320-dac898f53bb6 34 fields · synced May 30, 2026
- FDA 510(k) K220084 1 fields · synced May 18, 2026