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Non-contact thermometer
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref MDA 0203Model FR830
Identity
- Trade Name
- Non-contact thermometer EUDAMEDInfrared Thermometer FDA UDI
- Generic Name
- Infrared patient thermometer, skin FDA UDI
- Device Name
- Non-contact thermometer EUDAMED
- Model / Reference
- FR830 EUDAMEDFDA UDIMDA 0203 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06953205900825 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06953205900825 EUDAMED
- 510(k) Number
- K172874 FDA UDI
- FDA Product Code
- FLL FDA UDI
- EMDN Code
- V0301010202 NON-CONTACT DIGITAL THERMOMETERS 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
- Germany 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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
Non-contact thermometer by Shenzhen Jiacom Technology Co., Ltd — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06953205900825 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Shenzhen Jiacom Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000030041
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED f796b153-926a-4bc8-8973-368321cdbccd 61 fields · synced Jun 20, 2026
- FDA UDI f4114201-7d0d-435c-8278-0687d59cda7e 33 fields · synced May 30, 2026