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Infrared Thermometer
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref FC-IR3010Model FC-IR100
Identity
- Trade Name
- Infrared Thermometer EUDAMEDFinicare FDA UDI
- Generic Name
- Infrared patient thermometer, ear/skin FDA UDI
- Device Name
- Infrared Thermometer EUDAMED
- Model / Reference
- FC-IR100 EUDAMEDFC-IR3010 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971522820114 EUDAMEDFDA UDI
- Basic UDI-DI
- 697152282IR001D3 EUDAMEDB-06971522820114 EUDAMED
- 510(k) Number
- K181215 FDA UDI
- FDA Product Code
- FLL FDA UDI
- EMDN Code
- V0301010202 NON-CONTACT DIGITAL THERMOMETERS EUDAMED
- GMDN Term
- Infrared patient thermometer, ear/skin FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.2910 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Infrared Thermometer by Shenzhen Finicare Co., Ltd. — Class IIa — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 697152282IR001D3 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 697152282IR001D3 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Shenzhen Finicare Co., Ltd.
- EUDAMED SRN
- CN-MF-000024364
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (3)
- EUDAMED 84c22597-57db-459b-8dad-fe67b15bba95 61 fields · synced Jun 19, 2026
- EUDAMED a42b879b-c47e-48a8-bfb0-073ec5bfe99a 61 fields · synced May 17, 2026
- FDA UDI 49414da5-a198-4444-9954-d0a1abf3843c 33 fields · synced May 30, 2026