Infrared Thermometer
by Shenzhen Aeon Technology Co., Ltd. China EUDAMEDGUDID
Ref A202CModel A200, A201, A202, A201F, A201W, A202W, A202C, A202D, A202E, A202F
Product code DQAEMDN V03010199
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number69478325ITXX202401080063 | Date27 Jan 2026 | StatusActive |
| United States | GUDID listing GUDID | Number06947832500381 | Date16 Apr 2020 | StatusListed |
Coverage
- Active
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Infrared Thermometer EUDAMEDAeon GUDID
- Generic Name
- Pulse oximeter
- Model / Reference
- A200 EUDAMEDA201 EUDAMEDA202 EUDAMEDA201F EUDAMEDA201W EUDAMEDA202W EUDAMEDA202C EUDAMEDA202D EUDAMEDA202E EUDAMEDA202F EUDAMEDA340 GUDID
- Primary DI / UDI-DI
- 06947832500381
- Basic UDI-DI
- 69478325ITXX202401080063
- Direct Marketing DI
- 06947832500381
- 510(k) Number
- FDA Product Code
- DQA
- EMDN Code
- V03010199 Thermometers - other
- GMDN Term
- Pulse oximeter
- Device Class
- Class IIa EUDAMEDClass II GUDID
- Regulation Number
- 870.2700
- Market of Registration
- Poland
- Commercial Distribution
- Not in Commercial Distribution
- MRI Safety
- MR Unsafe
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | A200, A201, A202, A201F, A201W, A202W, A202C, A202D, A202E, A202F A202C | A340 |
| Device Class | Class IIa | Class II |
Manufacturer details
- EUDAMED SRN
- CN-MF-000012690
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Shenzhen Aeon Technology Co., Ltd.
Properties & raw data
Show properties, registry sources and raw records
Other properties (22)
- Sterile: No
- Single Use: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Incorporates Medicinal Product: No
- Prescription Use: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Lot / Batch Number: No
- Expiration Date: No
- Manufacturing Date: No
Sources (2)
- EUDAMED e34ad761-c1de-4075-9938-60c639785633
- FDA UDI fedc298a-f2b8-4b5c-8e44-08a2b29fae3b