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Infrared Thermometer
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref A200Model A200, A201, A202, A201F, A201W, A202W, A202C, A202D, A202E, A202F
Identity
- Trade Name
- Infrared Thermometer EUDAMEDAEON FDA UDI
- Generic Name
- Infrared patient thermometer, ear FDA UDI
- Device Name
- Infrared Thermometer EUDAMED
- Model / Reference
- A200, A201, A202, A201F, A201W, A202W, A202C, A202D, A202E, A202F EUDAMEDA200 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06947832550423 EUDAMED06947832500282 FDA UDI
- Basic UDI-DI
- 69478325ITXX202401080063 EUDAMEDB-06947832550423 EUDAMED
- Direct Marketing DI
- 06947832550423 EUDAMED
- 510(k) Number
- K171578 FDA UDI
- FDA Product Code
- FLL FDA UDI
- EMDN Code
- V03010199 THERMOMETERS - OTHER EUDAMED
- GMDN Term
- Infrared patient thermometer, ear FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.2910 FDA UDI
- Market of Registration
- Netherlands EUDAMEDPoland 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
No
FDA UDI
MR Unsafe FDA UDI
Infrared Thermometer by Shenzhen Aeon 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 | 69478325ITXX202401080063 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 69478325ITXX202401080063 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Shenzhen Aeon Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000012690
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (3)
- EUDAMED bca7885e-f89c-4b6d-a416-0f33d4f774ba 61 fields · synced Jul 9, 2026
- EUDAMED 2378182d-002c-421b-881a-2fe2c97f88f5 61 fields · synced May 19, 2026
- FDA UDI dac0b4d3-afdf-47bd-b9e0-1218830863c2 33 fields · synced May 29, 2026