Identity
- Trade Name
- ALPHAMED EUDAMED
- Device Name
- Infrared Thermometer EUDAMED
- Model / Reference
- UFR201 EUDAMED06953825909253 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06953825909253 EUDAMED
- Basic UDI-DI
- B-06953825909253 EUDAMED
- EMDN Code
- V0301010299 DIGITAL THERMOMETERS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Northern Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Alphamed by Shenzhen Urion Technology Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06953825909253 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen Urion Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000018740
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (1)
- EUDAMED 59bd4c0d-93d8-4df3-9ea1-7084f60b8021 61 fields · synced May 22, 2026