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Elisa Plate Reader - EUDAMED Registration 06936895302438

Access comprehensive regulatory information for Elisa Plate Reader 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 06936895302438 and manufactured by Biobase Biodustry(Shandong) Co.,Ltd. in China.

This page provides complete registration details including trade name (Elisa Plate Reader), manufacturer information, authorized representative details, competent authority (DE/CA20, Bezirksregierung Düsseldorf Dezernat 24), 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
06936895302438
No
Elisa Plate Reader
Trade Name: Elisa Plate Reader
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Device Description (EMDN)

IMMUNOCHEMISTRY READERS

Device Classification
Risk Class
Class A
CND Nomenclatures Code
W0201020201
Trade Name
Elisa Plate Reader
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06936895302438
Basic UDI
6936895BS0182K
Version Date
January 05, 2024
Manufacturer Last Update
June 13, 2022
Active Status
No
Manufacturer
Country
China
Country Type
NON_EU
Address
Mingshui Economic Devlopment Zone, Zhangqiu Dsitrict Jinan City
Email
rd2@biobase.cn
Authorized Representative
SRN
DE-AR-000005110
Country
Germany
Address
1 Kochstr Willich
Email
info.m@luxuslw.de
Telephone
+49 1715605732
Regulatory Information
Competent Authority
DE/CA20, Bezirksregierung Düsseldorf Dezernat 24
Applicable Legislation
IVDR (REGULATION (EU) 2017/746 on in vitro diagnostic medical devices)
Placed On The Market
Germany
Device Characteristics
Human Tissues
No
Animal Tissues
Yes