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Fully-Automatic PCR detector - EUDAMED Registration 16974900600169

Access comprehensive regulatory information for Fully-Automatic PCR detector 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 16974900600169 and manufactured by Zhuhai Shineway Biotech Co.,Ltd in China.

This page provides complete registration details including trade name (Fully-Automatic PCR detector), manufacturer information, authorized representative details, competent authority (DE/CA23 - Regierungsprรคsidium Darmstadt Dezernat IV/Da 45.2), 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
16974900600169
No
Fully-Automatic PCR detector
Trade Name: Fully-Automatic PCR detector
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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
Fully-Automatic PCR detector
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
16974900600169
Basic UDI
697490060AutoPocMDx2S
Version Date
September 27, 2024
Manufacturer Last Update
August 10, 2022
Active Status
No
Manufacturer
Country
China
Country Type
NON_EU
Address
No.16 Room 106, 303 and 306, building 5, No.16,Jinxing Road,Tangjiawan Town,High-tech District Zhuhai
Email
E-shineway@swtech.me
Authorized Representative
SRN
DE-AR-000007996
Country
Germany
Address
11 Koenigsberger Strasse Muenster Hessen
Email
contact@glgi.de
Telephone
004960714977513
Regulatory Information
Competent Authority
DE/CA23 - Regierungsprรคsidium Darmstadt Dezernat IV/Da 45.2
Applicable Legislation
IVDR (REGULATION (EU) 2017/746 on in vitro diagnostic medical devices)
Placed On The Market
Italy
Device Characteristics
Human Tissues
No
Animal Tissues
No