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EUDAMED registration 06974677691158No

Automatic Nucleic Acid Purification Instrument

Shanghai BioGerm Medical Technology Co., Ltd.Class AEU EUDAMEDTrade name: Automatic Nucleic Acid Purification Instrument
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class A
CND nomenclatures code
W02060201
Trade name
Automatic Nucleic Acid Purification Instrument
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
06974677691158
Basic UDI
6974677691158JN
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
PureCE B.V.
SRN
NL-AR-000006069
Country
Netherlands
Address
13 Distriebutieweg Waddinxveen
Email
info@purece.nl
Telephone
+31 10 899 0449
Regulatory information
Competent authority
DE/CA24 - Regierungspräsidium Darmstadt Abteilung Arbeitsschutz und Umwelt
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)

POST-ANALYSIS SAMPLE ARCHIVING SYSTEMS - INSTRUMENTS

About this record

Access comprehensive regulatory information for Automatic Nucleic Acid Purification Instrument 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 06974677691158 and manufactured by Shanghai BioGerm Medical Technology Co., Ltd. in China.

This page provides complete registration details including trade name (Automatic Nucleic Acid Purification Instrument), 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.