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COVID-19 Antigen Rapid Test Kit(Colloidal Gold) -for self-testing - EUDAMED Registration 06934822526018

Access comprehensive regulatory information for COVID-19 Antigen Rapid Test Kit(Colloidal Gold) -for self-testing in the European Union medical device market through Pure Global AI's free database. This IVD devices for self-testing device is registered with EU EUDAMED under Primary DI 06934822526018 and manufactured by Jiangsu Konsung Bio-Medical Science And Technology Co.,Ltd. in China.

This page provides complete registration details including 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
IVD devices for self-testing
06934822526018
No
COVID-19 Antigen Rapid Test Kit(Colloidal Gold) -for self-testing
EU EUDAMED Registered Medical Device
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Device Description (EMDN)

VIROLOGY - RT & POC - OTHER

Device Classification
Risk Class
IVD devices for self-testing
CND Nomenclatures Code
W0105099099
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06934822526018
Basic UDI
B-06934822526018
Version Date
November 18, 2022
Manufacturer Last Update
November 19, 2021
Active Status
No
Manufacturer
Country
China
Country Type
NON_EU
Address
NO. 8 Shengchang West Road, Danyang Development Zone Danyang Development Zone, Jiangsu Province
Email
libaohong@konsung.com
Authorized Representative
SRN
DE-AR-000000001
Country
Germany
Address
80 Eiffestraße Hamburg
Email
shholding@hotmail.com
Telephone
+49 40 2513175
Regulatory Information
Competent Authority
DE/CA05 - Behorde fur Justiz und Verbraucherschutz
Applicable Legislation
IVDD (Directive 98/79/EC on in vitro Diagnostic Medical Devices)
Placed On The Market
Germany
Device Characteristics
Human Tissues
No
Animal Tissues
Yes