Identity
- Trade Name
- Infrared Thermometer EUDAMED
- Device Name
- Infrared Thermometer EUDAMED
- Model / Reference
- FC-IR200 EUDAMEDFC-IR2000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971522820046 EUDAMED
- Basic UDI-DI
- B-06971522820046 EUDAMED697152282IR002D5 EUDAMED
- EMDN Code
- V0301010202 NON-CONTACT DIGITAL THERMOMETERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Ireland 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 Thermometer by Shenzhen Finicare Co., Ltd. — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
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-06971522820046 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06971522820046 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen Finicare Co., Ltd.
- EUDAMED SRN
- CN-MF-000024364
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (2)
- EUDAMED 3041d9d4-821f-4be5-8d78-cef3ed9a0bd0 61 fields · synced Jun 19, 2026
- EUDAMED 7344b2ff-728a-48ba-9b5d-d5b17ea32d4b 61 fields · synced May 19, 2026