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Infrared Thermometer
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref CFT-308CModel CFT-308,CFT-308C510(k) K211752Ref CFT-308
Identity
- Trade Name
- Infrared Thermometer EUDAMEDChoicemmed FDA UDI
- Generic Name
- Infrared patient thermometer, skin FDA UDI
- Device Name
- Infrared Thermometer EUDAMEDChoicemmed Infrared Thermometer CFT-308C FDA UDI
- Model / Reference
- CFT-308,CFT-308C EUDAMEDCFT-308C EUDAMEDFDA UDICFT-308 EUDAMED
- Description
- Choicemmed Infrared Thermometer CFT-308C FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06942820422188 EUDAMED06942820421907 EUDAMED06942820462177 FDA UDI
- Basic UDI-DI
- 69428204TEMBUQ EUDAMEDB-06942820421907 EUDAMED
- 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Infrared Thermometer by Beijing Choice Electronic Technology Co., Ltd. — Class IIa — MDD, FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 69428204TEMBUQ | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K211752 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 69428204TEMBUQ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Beijing Choice Electronic Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000005776
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (4)
- EUDAMED 525d6036-4c4c-4a42-adca-21466b315145 85 fields · synced Jul 12, 2026
- FDA UDI 1df54708-6c29-4e8a-b6b8-abd20f2a7ce3 33 fields · synced May 30, 2026
- EUDAMED a456054d-5576-41d3-9e42-5129188d4a2a 61 fields · synced Jul 12, 2026
- FDA 510(k) K211752 1 fields · synced May 18, 2026