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Infrared Thermometer - EUDAMED Registration 06953775660754

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 06953775660754 and manufactured by Alicn Medical Shenzhen, Inc in China.

This page provides complete registration details including trade name (4FIZJO Infrared Thermometer), manufacturer information, authorized representative details, competent authority (Agencia Espaรฑola de Medicamentos y Productos Sanitarios), 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
06953775660754
Yes
Infrared Thermometer
Trade Name: 4FIZJO Infrared Thermometer
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Device Description (EMDN)

NON-CONTACT DIGITAL THERMOMETERS

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
V0301010202
Trade Name
4FIZJO Infrared Thermometer
Implantable
No
Reusable
No
Measuring Function
Yes
Registration Information
Primary DI
06953775660754
Basic UDI
69537756R1B1VP
Version Date
February 13, 2025
Manufacturer Last Update
June 20, 2024
Active Status
Yes
Manufacturer
Country
China
Country Type
NON_EU
Address
Room 4C, Building 1, Zhongcheng Biomedical Industrial Park, No. 21 Linhui Road, Jinsha Community, Kengzi Street, Pingshan District Shenzhen, Guangdong
Email
huangrenxiong@alicn-med.com
Authorized Representative
SRN
ES-AR-000000293
Country
Spain
Address
C/ Horacio Lengo N18 Mรกlaga
Email
info@cmcmedicaldevices.com
Telephone
+34951214054
Regulatory Information
Competent Authority
Agencia Espaรฑola de Medicamentos y Productos Sanitarios
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Poland
Market Available
Poland:None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No