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Infrared Thermometer - EUDAMED Registration 06953825901073

Access comprehensive regulatory information for Infrared Thermometer in the European Union medical device market through Pure Global AI's free database. This Class IIa device is registered with EU EUDAMED under Primary DI 06953825901073 and manufactured by Shenzhen Urion Technology Co., Ltd. in China.

This page provides complete registration details including trade name (ALphaMed), manufacturer information, authorized representative details, competent authority (DE/CA05 - Behorde fur Justiz und Verbraucherschutz), and regulatory compliance data from the official EU EUDAMED medical device database. Pure Global AI offers free access to the European Union's complete medical device registry, helping global MedTech companies navigate EU MDR regulations efficiently.

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EUDAMED Official Data
Class IIa
06953825901073
Yes
Infrared Thermometer
Trade Name: ALphaMed
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Device Description (EMDN)

DIGITAL THERMOMETERS - OTHER

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
V0301010299
Trade Name
ALphaMed
Implantable
No
Reusable
No
Measuring Function
Yes
Registration Information
Primary DI
06953825901073
Basic UDI
B-06953825901073
Version Date
March 10, 2025
Manufacturer Last Update
March 20, 2024
Active Status
Yes
Manufacturer
Country
China
Country Type
NON_EU
Address
No.3 Floor 4-6th of Building D, Jiale Science&Technology Industrial Zone, No.3, ChuangWei Road, Heshuikou Community, MaTian Street, GuangMing New District Shenzhen
Email
urion@urion.com.cn
Authorized Representative
SRN
XI-AR-000001836
Country
United Kingdom (Northern Ireland only)
Address
Enterprise Hub, NW Business Complex, Derry
Email
AuthRep@CE-marking.eu
Telephone
+44(33)33031126
Regulatory Information
Competent Authority
DE/CA05 - Behorde fur Justiz und Verbraucherschutz
Applicable Legislation
MDD (Directive 93/42/EEC on Medical Devices)
Placed On The Market
Italy
Market Available
Italy:2025-03-10~2028-12-31
Device Characteristics
Human Tissues
No
Animal Tissues
No