← Back to catalogue
Non-contact thermometer
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref MDA 0203Model FR880Model FR800，FR840，FR870，FR880
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
- FR880 EUDAMEDFDA UDIMDA 0203 EUDAMEDFR800，FR840，FR870，FR880 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06953205900863 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06953205900863 EUDAMED6953205903AL EUDAMED
- Direct Marketing DI
- 06953205900863 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 — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06953205900863 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06953205900863 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen Jiacom Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000030041
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (3)
- EUDAMED 9d791714-7d89-4ae2-9c55-e1139be13ca0 61 fields · synced Jun 19, 2026
- EUDAMED d7fe2b9d-fda4-4bb9-bdd3-ce9f33ef9f31 61 fields · synced May 18, 2026
- FDA UDI 110115c5-9ce4-4b04-85da-c9ab13c2246d 33 fields · synced May 30, 2026