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Real-time PCR Detection System - EUDAMED Registration 06928103081204

Access comprehensive regulatory information for Real-time PCR Detection System 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 06928103081204 and manufactured by Daan Gene Co., Ltd. in China.

This page provides complete registration details including trade name (Real-time PCR Detection System), 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
06928103081204
No
Real-time PCR Detection System
Trade Name: Real-time PCR Detection System
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Device Description (EMDN)

NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS

Device Classification
Risk Class
Class A
CND Nomenclatures Code
W02050116
Trade Name
Real-time PCR Detection System
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06928103081204
Basic UDI
69281030812XFW
Version Date
August 31, 2023
Manufacturer Last Update
July 07, 2022
Active Status
No
Manufacturer
Manufacturer Name
Daan Gene Co., Ltd.
Country
China
Country Type
NON_EU
Address
No. 19 Xiangshan Road, Science Park, High & New Technology Development District Guangzhou
Email
hj@daangene.com
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
Netherlands
Device Characteristics
Human Tissues
No
Animal Tissues
No