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EUDAMED registration 06974677690298No

Novel Coronavirus (SARS-CoV-2) Nucleic Acid Detection Kit (Fluorescent RT-MIRA)

Shanghai BioGerm Medical Technology Co., Ltd.IVD GeneralEU EUDAMEDTrade name: Novel Coronavirus (SARS-CoV-2) Nucleic Acid Detection Kit (Fluorescent RT-MIRA)
VerifiedEUDAMED · official EU database
Device classification
Risk class
IVD General
CND nomenclatures code
W0105900102
Trade name
Novel Coronavirus (SARS-CoV-2) Nucleic Acid Detection Kit (Fluorescent RT-MIRA)
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
06974677690298
Basic UDI
B-06974677690298
Version date
September 21, 2023
Manufacturer last update
June 16, 2023
Active status
No
Manufacturer
Manufacturer name
Shanghai BioGerm Medical Technology Co., Ltd.
Country
China
Country type
NON_EU
Address
Room 1302,1303,1304,1305,1306,1307,1309, Building 3, No. 1588 Huhang Road, Fengxian District, Shanghai, China Shanghai
Email
bojiezhuce@bio-germ.com
Authorized representative
Name
PureMDR GmbH
SRN
DE-AR-000007923
Country
Germany
Address
42 Eschersheimer Landstraße 60322 Frankfurt am Main
Email
ear@puremdr.com
Regulatory information
Competent authority
DE/CA24 - Regierungspräsidium Darmstadt Abteilung Arbeitsschutz und Umwelt
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
No
Device description (EMDN)

REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS

About this record

Access comprehensive regulatory information for Novel Coronavirus (SARS-CoV-2) Nucleic Acid Detection Kit (Fluorescent RT-MIRA) in the European Union medical device market through Pure Global AI's free database. This IVD General device is registered with EU EUDAMED under Primary DI 06974677690298 and manufactured by Shanghai BioGerm Medical Technology Co., Ltd. in China.

This page provides complete registration details including trade name (Novel Coronavirus (SARS-CoV-2) Nucleic Acid Detection Kit (Fluorescent RT-MIRA)), manufacturer information, authorized representative details, competent authority (DE/CA24 - Regierungspräsidium Darmstadt Abteilung Arbeitsschutz und Umwelt), 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.