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Infrared thermometer
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref FDIR-V7Ref FDIR-V12Ref FDIR-V22Ref FDIR-V13Ref FDIR-V5Ref FDIR-V9
Identity
- Trade Name
- Infrared thermometer EUDAMEDFamidoc FDA UDI
- Generic Name
- Infrared patient thermometer, skin FDA UDI
- Device Name
- Infrared Thermometer EUDAMED
- Model / Reference
- FDIR-V7 EUDAMEDFDIR-V12 EUDAMEDFDIR-V22 EUDAMEDFDIR-V13 EUDAMEDFDIR-V5 EUDAMEDFDA UDIFDIR-V9 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970389631246 EUDAMED06970389631000 EUDAMED06970389631512 EUDAMED06970389631147 EUDAMED06970389631055 EUDAMEDFDA UDI06970389632274 EUDAMED
- Basic UDI-DI
- 697038963FDIRNZ EUDAMED
- Direct Marketing DI
- 06970389631246 EUDAMED06970389631147 EUDAMED06970389631055 EUDAMED06970389632274 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 EUDAMEDCzechia 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 — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697038963FDIRNZ | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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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 (7)
- EUDAMED 6baf2a25-c9c5-4148-99d2-80e35a3386b4 61 fields · synced Aug 1, 2026
- EUDAMED 0c0b8afb-b7f8-463d-8764-90304277cddd 61 fields · synced May 17, 2026
- EUDAMED 66ebbb95-3273-4751-982a-1a8da81c5f0c 61 fields · synced May 17, 2026
- EUDAMED 4ca3de79-7522-4aca-a9b8-b849dfbb5dbf 61 fields · synced May 18, 2026
- EUDAMED 21b5b5da-4fad-4d63-9c16-cacd271c0efb 61 fields · synced May 18, 2026
- EUDAMED e4b283fe-f18a-42d0-b84b-ef0a7b19c7a1 61 fields · synced May 19, 2026
- FDA UDI f948ca3c-bacb-4dca-8988-689bde43e96f 33 fields · synced May 29, 2026