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Infrared Thermometer
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref A202Model A200, A201, A202, A201F, A201W, A202W, A202C, A202D, A202E, A202F
Identity
- Trade Name
- Infrared Thermometer EUDAMEDAEON FDA UDI
- Generic Name
- Pulse oximeter FDA UDI
- Device Name
- Infrared Thermometer EUDAMED
- Model / Reference
- A202 EUDAMEDA200, A201, A202, A201F, A201W, A202W, A202C, A202D, A202E, A202F EUDAMEDA310 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06947832500039 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06947832500039 EUDAMED69478325ITXX202401080063 EUDAMED
- Direct Marketing DI
- 06947832500039 EUDAMED
- 510(k) Number
- K153021 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
- Poland EUDAMEDGermany 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 — 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-06947832500039 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06947832500039 | 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 f68983eb-50cb-4411-ba98-4fa6f3eb0771 61 fields · synced Jul 30, 2026
- EUDAMED 047e6b5d-5d7c-4ee2-9c09-b3d84fcef3ed 61 fields · synced May 19, 2026
- FDA UDI 179fa82a-a492-4625-9e66-53e169689569 33 fields · synced May 30, 2026