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ELYSIUM Electronic Thermometer
EUDAMEDClass IIa (EU MDR)
Ref AET-F346Ref AET-F344
Identity
- Trade Name
- ELYSIUM Electronic Thermometer EUDAMED
- Device Name
- Electronic Thermometer EUDAMED
- Model / Reference
- AET-F346 EUDAMEDAET-F344 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06953775660969 EUDAMED06953775660945 EUDAMED
- Basic UDI-DI
- 69537756F3XXXT EUDAMED
- EMDN Code
- V0301010201 CONTACT DIGITAL THERMOMETERS (INCLUDING PROBES) EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Hungary EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
ELYSIUM Electronic Thermometer by Alicn Medical Shenzhen, Inc — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69537756F3XXXT | Class IIa | Active |
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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 edcf90bb-6a5b-4752-a6f8-d31d1ecdf2e1 61 fields · synced Jul 11, 2026
- EUDAMED 5b5a0ba6-1761-4742-8ef2-b66d5344b110 61 fields · synced May 18, 2026