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Infrared Thermometer
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref A202WModel A200, A201, A202, A201F, A201W, A202W, A202C, A202D, A202E, A202FRef A202CRef A201FRef A201W
Identity
- Trade Name
- Infrared Thermometer EUDAMEDAEON FDA UDI
- Generic Name
- Pulse oximeter FDA UDI
- Device Name
- Infrared Thermometer EUDAMED
- Model / Reference
- A200, A201, A202, A201F, A201W, A202W, A202C, A202D, A202E, A202F EUDAMEDA202W EUDAMEDA202C EUDAMEDA201F EUDAMEDA201W EUDAMEDA340 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06947832500596 EUDAMED06947832500381 EUDAMEDFDA UDI06947832500589 EUDAMED06947832500572 EUDAMED
- Basic UDI-DI
- 69478325ITXX202401080063 EUDAMED
- Direct Marketing DI
- 06947832500596 EUDAMED06947832500381 EUDAMED06947832500589 EUDAMED06947832500572 EUDAMED
- 510(k) Number
- K190869 FDA UDI
- FDA Product Code
- DQA FDA UDI
- EMDN Code
- V03010199 THERMOMETERS - OTHER EUDAMED
- GMDN Term
- Pulse oximeter FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2700 FDA UDI
- Market of Registration
- Italy EUDAMEDPoland EUDAMED
- Commercial Distribution
- Not 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 — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K171578 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 69478325ITXX202401080063 | Class IIa | Active |
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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 (7)
- EUDAMED 3d56d3a2-8d25-400b-a81e-9e2c00ee68f3 61 fields · synced Sep 18, 2026
- EUDAMED e34ad761-c1de-4075-9938-60c639785633 61 fields · synced May 16, 2026
- EUDAMED fba5030a-09b0-468f-a1dc-01052cd87a30 61 fields · synced May 18, 2026
- EUDAMED 3d04647b-0d33-4707-ad82-7539977668fa 61 fields · synced May 18, 2026
- FDA UDI fedc298a-f2b8-4b5c-8e44-08a2b29fae3b 34 fields · synced May 30, 2026
- EUDAMED 5e0f714a-6ff8-4b1e-b0a6-749cf5faf726 61 fields · synced Jul 8, 2026
- FDA 510(k) K171578 1 fields · synced May 18, 2026