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Non-contact thermometer
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 69532059Model FR800，FR840，FR870，FR880Ref FR800Ref MDA 0203
Identity
- Trade Name
- Non-contact thermometer EUDAMEDNon-contact digital thermometers EUDAMEDInfrared Thermometer FDA UDI
- Generic Name
- Infrared patient thermometer, skin FDA UDI
- Device Name
- Non-contact thermometer EUDAMED
- Model / Reference
- FR800，FR840，FR870，FR880 EUDAMED69532059 EUDAMEDFR800 EUDAMEDFDA UDIMDA 0203 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06953205900818 EUDAMEDFDA UDI06953205995043 EUDAMED
- Basic UDI-DI
- 6953205903AL EUDAMEDB-06953205900818 EUDAMED
- Direct Marketing DI
- 06953205900818 EUDAMED06953205995043 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
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
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, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 6953205903AL | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 6953205903AL | 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
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (4)
- EUDAMED 1191bcc5-817e-42f0-9c1c-83f7fca2a792 61 fields · synced Oct 6, 2026
- EUDAMED 12ac86df-86c8-4dc4-bf14-eb073be67164 61 fields · synced May 11, 2026
- EUDAMED a0886ba8-85de-4244-ad80-aab9b8675607 61 fields · synced May 19, 2026
- FDA UDI 2945ea0c-bf60-481b-80ff-bbd658ef62dc 33 fields · synced May 30, 2026