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TANBead Nucleic Acid Extraction Kit - EUDAMED Registration 04719880122721

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 04719880122721 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.

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EUDAMED Official Data
Class A
04719880122721
No
TANBead Nucleic Acid Extraction Kit
EU EUDAMED Registered Medical Device
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Device Description (EMDN)

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

Device Classification
Risk Class
Class A
CND Nomenclatures Code
W0105900101
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
04719880122721
Basic UDI
4719880126T2K9
Version Date
April 26, 2023
Manufacturer Last Update
October 12, 2022
Active Status
No
Manufacturer
Country
Taiwan
Country Type
NON_EU
Address
6F., No.188 Wenhe Rd., Guishan Dist., Taoyuan City
Email
lesley.lin@tanbead.com
Authorized Representative
SRN
DE-AR-000006218
Country
Germany
Address
71 Langenhagener StraรŸe 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:2022-05-26~2027-05-26, Belgium:2022-05-26~2027-05-26, Czechia:2022-05-26~2027-05-26, France:2022-05-26~2027-05-26, Germany:2022-05-26~2027-05-26, Greece:2022-05-26~2027-05-26, Italy:2022-05-26~2027-05-26, Poland:2022-05-26~2027-05-26, Slovakia:2022-05-26~2027-05-26, Spain:2022-07-15~2027-07-15, Sweden:2022-06-02~2027-06-02
Device Characteristics
Human Tissues
Yes
Animal Tissues
No