Pure Global
04719880124121

TANBead Nucleic Acid Extraction Kit

Taiwan Advanced Nanotech Inc.·Class A·EU EUDAMEDNo
Device classification
Risk class
Class A
CND nomenclatures code
W0105900101
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
04719880124121
Basic UDI
47198801261CH3
Version date
February 24, 2025
Manufacturer last update
April 25, 2024
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
sam.yu@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
Austria
Market available
Austria:2024-12-09~2029-12-09, Belgium:2024-12-09~2029-12-09, Czechia:2024-12-09~2029-12-09, France:2024-12-09~2029-12-09, Germany:2024-12-09~2029-12-09, Greece:2024-12-09~2029-12-09, Italy:2024-12-09~2029-12-09, Poland:2024-12-09~2029-12-09, Slovenia:2024-12-09~2029-12-09, Spain:2024-12-09~2029-12-09, Sweden:2024-12-09~2029-12-09
Device characteristics
Human tissues
Yes
Animal tissues
No
Device description (EMDN)

REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS

About this record

Access comprehensive regulatory information for TANBead Nucleic Acid Extraction Kit 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 04719880124121 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.