Identity
- Trade Name
- Infrared Ear thermometer EUDAMED
- Device Name
- Infrared Ear thermometer EUDAMED
- Model / Reference
- IRT10A EUDAMEDIRT10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945429020892 EUDAMED06945429020885 EUDAMED
- Basic UDI-DI
- B-06945429020892 EUDAMEDB-06945429020885 EUDAMED
- EMDN Code
- V0301010201 CONTACT DIGITAL THERMOMETERS (INCLUDING PROBES) EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Belgium 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
Infrared Ear thermometer by Shenzhen Comen Medical Instruments Co., LTD. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06945429020892 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen Comen Medical Instruments Co., LTD.
- EUDAMED SRN
- CN-MF-000002236
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED 0d0a637c-7a79-43ec-830e-aa92a0a00dc2 61 fields · synced Oct 6, 2026
- EUDAMED 7d9f4847-ec33-433f-afa4-a9d377300b63 61 fields · synced May 18, 2026