Identity
- Trade Name
- Infrared Forehead Thermometer EUDAMED
- Device Name
- Infrared Forehead Thermometer EUDAMED
- Model / Reference
- DET-306 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970392219486 EUDAMED
- Basic UDI-DI
- B-06970392219486 EUDAMED6970392211ET000635 EUDAMED
- Direct Marketing DI
- 06970392219486 EUDAMED
- EMDN Code
- V0301010202 NON-CONTACT DIGITAL THERMOMETERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMEDFrance 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 Forehead Thermometer is a Class IIa medical device designed for non-invasive temperature measurement. It provides accurate and reliable readings, making it an ideal tool for healthcare professionals. With its compact size and user-friendly interface, this device is perfect for a wide range of applications.
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06970392219486 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06970392219486 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- JOYTECH Healthcare Co., Ltd.
- EUDAMED SRN
- CN-MF-000006020
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 8f062fbc-01a2-452c-b17c-cddb774ae7d4 61 fields · synced Jul 29, 2026
- EUDAMED e39664d7-f438-4189-aa0c-8d387c4c3a9c 61 fields · synced May 19, 2026