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Automated Nucleic Acid Extraction Instrument(EX1600) - EUDAMED Registration 06974613762027

Access comprehensive regulatory information for Automated Nucleic Acid Extraction Instrument(EX1600) 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 06974613762027 and manufactured by Shanghai ZJ Bio-Tech Co., Ltd. in China.

This page provides complete registration details including 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.

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EUDAMED Official Data
Class A
06974613762027
No
Automated Nucleic Acid Extraction Instrument(EX1600)
EU EUDAMED Registered Medical Device
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Device Description (EMDN)

IVD INSTRUMENTS - OTHER

Device Classification
Risk Class
Class A
CND Nomenclatures Code
W0299
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06974613762027
Basic UDI
697461376010001SV
Version Date
August 19, 2022
Manufacturer Last Update
September 02, 2022
Active Status
No
Manufacturer
Country
China
Country Type
NON_EU
Address
188 Xinjunhuan Road Suite 201, Building #15, 188 Xinjunhuan Road, Minhang District Shanghai
Email
registration@liferiver.com.cn
Authorized Representative
SRN
NL-AR-000000121
Country
Netherlands
Address
Koningin Julianaplein 10, 1e Verd The Hague
Email
peter@lotusnl.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
Austria
Device Characteristics
Human Tissues
Yes
Animal Tissues
No