Identity
- Trade Name
- Infrared thermometer EUDAMED
- Device Name
- Infrared Thermometer EUDAMED
- Model / Reference
- FDIR-V1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970389632267 EUDAMED
- Basic UDI-DI
- 697038963FDIRNZ EUDAMED
- Direct Marketing DI
- 06970389632267 EUDAMED
- EMDN Code
- V0301010201 CONTACT DIGITAL THERMOMETERS (INCLUDING PROBES) EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Northern 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 Famidoc Technology Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K052849 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 697038963FDIRNZ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Famidoc Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000016603
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 8a936d83-07ba-4a13-a5d7-7a78f5c9d1f4 61 fields · synced Jun 19, 2026
- FDA 510(k) K052849 1 fields · synced May 18, 2026