Identity
- Trade Name
- Infrared Ear Thermometer EUDAMED
- Device Name
- Infrared Ear Thermometer EUDAMED
- Model / Reference
- DET EUDAMEDDET-101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942284605424 EUDAMED
- Basic UDI-DI
- 6970392211ET00012T EUDAMEDB-06942284605424 EUDAMED
- Direct Marketing DI
- 06942284605424 EUDAMED
- EMDN Code
- V0301010201 CONTACT DIGITAL THERMOMETERS (INCLUDING PROBES) EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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 Ear Thermometer by Joytech Healthcare Co., Ltd. — Class IIa — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 6970392211ET00012T | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 6970392211ET00012T | Class IIa | Active |
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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 1179a595-7fca-4f77-9dd2-ebc1195b6352 61 fields · synced Jun 18, 2026
- EUDAMED b9d4dd18-b260-437a-b29f-2350018af301 61 fields · synced May 19, 2026