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Non-contact Infrared Thermometer - EUDAMED Registration 05055382309284

Access comprehensive regulatory information for Non-contact 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 05055382309284 and manufactured by Guangzhou Berrcom Medical Device Co., Ltd. in China.

This page provides complete registration details including trade name (Alvita), 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
05055382309284
Yes
Non-contact Infrared Thermometer
Trade Name: Alvita
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Device Description (EMDN)

NON-CONTACT DIGITAL THERMOMETERS

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
V0301010202
Trade Name
Alvita
Implantable
No
Reusable
No
Measuring Function
Yes
Registration Information
Primary DI
05055382309284
Basic UDI
69476561JXB-XXX7T
Active Status
Yes
Manufacturer
Country
China
Country Type
NON_EU
Address
No.38 No.38, Huanzhen Xi Road, Dagang Town, Nansha Guangzhou, Guangdong
Email
info@berrcom.com
Authorized Representative
SRN
DE-AR-000000001
Country
Germany
Address
80 EiffestraรŸe Hamburg
Email
shholding@hotmail.com
Telephone
+49 40 2513175
Regulatory Information
Competent Authority
DE/CA05 - Behorde fur Justiz und Verbraucherschutz
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
France
Market Available
France:None~None, Portugal:None~None, Spain:None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No