Identity
- Trade Name
- OffiSoins Infrared Thermometer EUDAMED
- Device Name
- Infrared Thermometer EUDAMED
- Model / Reference
- FC-IR100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971522821395 EUDAMED
- Basic UDI-DI
- 697152282IR001D3 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
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
OffiSoins Infrared Thermometer by Shenzhen Finicare Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697152282IR001D3 | 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 (1)
- EUDAMED 231588f9-2fce-41d4-86bf-577e35b475b7 61 fields · synced Jun 18, 2026