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EUDAMED registration 06975489970028No

TGuide S16 Nucleic Acid Extractor

Tiangen Biotech (Beijing) Co., Ltd.Class AEU EUDAMEDTrade name: TGuide S16 Nucleic Acid Extractor
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class A
CND nomenclatures code
W02060199
Trade name
TGuide S16 Nucleic Acid Extractor
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
06975489970028
Basic UDI
697548997OSES168A
Version date
December 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
SUNGO Europe B.V.
SRN
NL-AR-000000247
Country
Netherlands
Address
Fascinatio Boulevard 522, Unit 1.7, Capelle aan den IJssel
Email
ec.rep@sungoglobal.com
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)

ROBOTIC SAMPLE PROCESSING SYSTEMS - OTHER

About this record

Access comprehensive regulatory information for TGuide S16 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 06975489970028 and manufactured by Tiangen Biotech (Beijing) Co., Ltd. in China.

This page provides complete registration details including trade name (TGuide S16 Nucleic Acid Extractor), 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.