Identity
- Trade Name
- Infrared thermometer EUDAMEDFamidoc FDA UDI
- Generic Name
- Infrared patient thermometer, skin FDA UDI
- Device Name
- Infrared Thermometer EUDAMED
- Model / Reference
- FDIR-V10 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970389631109 EUDAMEDFDA UDI
- Basic UDI-DI
- 697038963FDIRNZ EUDAMED
- Direct Marketing DI
- 06970389631109 EUDAMED
- 510(k) Number
- K113761 FDA UDI
- FDA Product Code
- FLL FDA UDI
- EMDN Code
- V0301010201 CONTACT DIGITAL THERMOMETERS (INCLUDING PROBES) EUDAMED
- GMDN Term
- Infrared patient thermometer, skin FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.2910 FDA UDI
- Market of Registration
- Northern Ireland EUDAMED
- 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
Yes
FDA UDI
Infrared thermometer by Famidoc Technology Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, 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 | K113761 | 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 (3)
- EUDAMED 4398c8be-67f3-4d36-99d0-904288796c8a 61 fields · synced Aug 4, 2026
- FDA UDI 8f9a7de3-463f-4edd-a9f6-b6b7d87964b6 33 fields · synced May 29, 2026
- FDA 510(k) K113761 1 fields · synced May 18, 2026