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EUDAMED registration 06974901970028No

Nucleic Acid Extractor

Shandong Bohong Gene Technology Co., Ltd.Class AEU EUDAMEDTrade name: Nucleic Acid Extractor
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class A
CND nomenclatures code
W02050116
Trade name
Nucleic Acid Extractor
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
06974901970028
Basic UDI
6974901BH003U2
Version date
November 14, 2022
Manufacturer last update
July 12, 2022
Active status
No
Manufacturer
Manufacturer name
Shandong Bohong Gene Technology Co., Ltd.
Country
China
Country type
NON_EU
Address
1st Floor of Building 2, BIOBASE Headquarters, north of Gangyuan 7th Road and west of Gangxingyuan Road, Pilot Free Trade Zone of Jinan 250101 Jinan
Email
base@biobase.cn
Authorized representative
Name
Luxus Lebenswelt GmbH
SRN
DE-AR-000005110
Country
Germany
Address
1 Kochstr Willich
Email
info.m@luxuslw.de
Telephone
+49 1715605732
Regulatory information
Competent authority
DE/CA20, Bezirksregierung Düsseldorf Dezernat 24
Applicable legislation
IVDR (REGULATION (EU) 2017/746 on in vitro diagnostic medical devices)
Placed on the market
Germany
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS

About this record

Access comprehensive regulatory information for Nucleic Acid Extractor in the European Union medical device market through Pure Global AI's free database. This Class A device is registered with EU EUDAMED under Primary DI 06974901970028 and manufactured by Shandong Bohong Gene Technology Co., Ltd. in China.

This page provides complete registration details including trade name (Nucleic Acid Extractor), manufacturer information, authorized representative details, competent authority (DE/CA20, Bezirksregierung Düsseldorf Dezernat 24), 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.