Identity
- Trade Name
- AILIFEE EUDAMEDFDA UDI
- Generic Name
- Continuous electronic patient thermometer, battery-powered FDA UDI
- Device Name
- Electronic Thermometer EUDAMED
- Model / Reference
- AET-F355 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06953775661638 EUDAMEDFDA UDI
- Basic UDI-DI
- 69537756F3XXXT EUDAMED
- 510(k) Number
- K232338 FDA UDI
- FDA Product Code
- FLL FDA UDI
- EMDN Code
- V0301010201 CONTACT DIGITAL THERMOMETERS (INCLUDING PROBES) EUDAMED
- GMDN Term
- Continuous electronic patient thermometer, battery-powered FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.2910 FDA UDI
- Market of Registration
- Ireland 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Ailifee by Alicn Medical Shenzhen, Inc — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69537756F3XXXT | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Alicn Medical Shenzhen, Inc
- EUDAMED SRN
- CN-MF-000001920
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED f0bd419d-bfdc-4d21-b10f-d7ae2beba469 61 fields · synced Jul 14, 2026
- FDA UDI 54391a7f-595c-471d-8a55-37d08e80c107 33 fields · synced May 30, 2026