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EUDAMED registration 06975489971162No

TGuide S96 Magnetic Viral DNA/RNA Kit

Tiangen Biotech (Beijing) Co., Ltd.Class AEU EUDAMEDTrade name: TGuide S96 Magnetic Viral DNA/RNA Kit
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class A
CND nomenclatures code
W010699
Trade name
TGuide S96 Magnetic Viral DNA/RNA Kit
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
06975489971162
Basic UDI
697548997CDP804UA
Version date
September 21, 2022
Manufacturer last update
July 28, 2022
Active status
No
Manufacturer
Manufacturer name
Tiangen Biotech (Beijing) Co., Ltd.
Country
China
Country type
NON_EU
Address
Building 5, No. 86 Yard Shuangying West Road Beijing
Email
ran.zhang@tiangen.com
Authorized representative
Name
Humiss International B.V.
SRN
NL-AR-000001490
Country
Netherlands
Address
701 Joop Geesinkweg Amsterdam-Duivendrech
Email
ce-tech@humiss.com
Telephone
+31 (0)20 369 8116
Regulatory information
Competent authority
Ministerie van Volksgezondheid, Welzijn en Sport
Applicable legislation
IVDR (REGULATION (EU) 2017/746 on in vitro diagnostic medical devices)
Placed on the market
France
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

GENETIC TESTS - OTHER

About this record

Access comprehensive regulatory information for TGuide S96 Magnetic Viral DNA/RNA 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 06975489971162 and manufactured by Tiangen Biotech (Beijing) Co., Ltd. in China.

This page provides complete registration details including trade name (TGuide S96 Magnetic Viral DNA/RNA Kit), manufacturer information, authorized representative details, competent authority (Ministerie van Volksgezondheid, Welzijn en Sport), 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.