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Forehead Infrared Thermometer
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref IRT-40V3510(k) K191251
Identity
- Trade Name
- Forehead Infrared Thermometer EUDAMED
- Device Name
- Forehead Infrared Thermometer EUDAMED
- Model / Reference
- IRT-40V3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-CNMF000025924IRT-40V3Q7 EUDAMED
- Basic UDI-DI
- B-CNMF000025924IRT-40V3Q7 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
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
Forehead Infrared Thermometer by Shenzhen Calibeur Industries Co., Ltd. — Class IIa — FDA_510K, MDD — listed in EUDAMED, 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 | K191251 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-CNMF000025924IRT-40V3Q7 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen Calibeur Industries Co., Ltd.
- EUDAMED SRN
- CN-MF-000025924
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (2)
- EUDAMED 4e0ce64a-7a0e-433a-bb2d-6d9704f12225 85 fields · synced Jun 19, 2026
- FDA 510(k) K191251 1 fields · synced May 18, 2026