Pure Global
04719880128785

TANBead Nucleic Acid Extractor

Taiwan Advanced Nanotech Inc.·Class A·EU EUDAMEDNo
Device classification
Risk class
Class A
CND nomenclatures code
W02050116
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
04719880128785
Basic UDI
471988012S04LG
Version date
April 27, 2023
Manufacturer last update
October 12, 2022
Active status
No
Manufacturer
Manufacturer name
Taiwan Advanced Nanotech Inc.
Country
Taiwan
Country type
NON_EU
Address
6F., No.188 Wenhe Rd., Guishan Dist., Taoyuan City
Email
lesley.lin@tanbead.com
Authorized representative
Name
mdi Europa GmbH
SRN
DE-AR-000006218
Country
Germany
Address
71 Langenhagener Straße Langenhagen
Email
info@mdi-europa.com
Regulatory information
Competent authority
DE/CA09 - Staatliches Gewerbeaufsichtsamt Hannover
Applicable legislation
IVDR (REGULATION (EU) 2017/746 on in vitro diagnostic medical devices)
Placed on the market
Germany
Market available
Austria:2023-02-15~2028-02-15, Belgium:2023-02-15~2028-02-15, Czechia:2023-02-15~2028-02-15, France:2023-02-15~2028-02-15, Germany:2023-02-15~2028-02-15, Greece:2023-02-15~2028-02-15, Italy:2023-02-15~2028-02-15, Poland:2023-02-15~2028-02-15, Slovakia:2023-02-15~2028-02-15, Spain:2023-02-15~2028-02-15, Sweden:2023-02-15~2028-02-15
Device characteristics
Human tissues
Yes
Animal tissues
No
Device description (EMDN)

NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS

About this record

Access comprehensive regulatory information for TANBead 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 04719880128785 and manufactured by Taiwan Advanced Nanotech Inc. in Taiwan.

This page provides complete registration details including manufacturer information, authorized representative details, competent authority (DE/CA09 - Staatliches Gewerbeaufsichtsamt Hannover), 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.