Pure Global

Fully Atomated CLIA Analyzer - EUDAMED Registration 06975070765477

Access comprehensive regulatory information for Fully Atomated CLIA Analyzer 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 06975070765477 and manufactured by C-Luminary Biotechnology Co., Ltd. in China.

This page provides complete registration details including trade name (Fully Automated CLIA Analyzer), manufacturer information, authorized representative details, competent authority (DE/CA20, Bezirksregierung Dรผsseldorf 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
06975070765477
No
Fully Atomated CLIA Analyzer
Trade Name: Fully Automated CLIA Analyzer
Pure Global
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DJ Fang

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Device Description (EMDN)

RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER

Device Classification
Risk Class
Class A
CND Nomenclatures Code
W02020699
Trade Name
Fully Automated CLIA Analyzer
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06975070765477
Basic UDI
697507076CLSharay8000GV
Version Date
August 27, 2024
Manufacturer Last Update
April 25, 2023
Active Status
No
Manufacturer
Country
China
Country Type
NON_EU
Address
Building #3, No. 6, Xixin Avenue, High-tech zone, Chengdu, Sichuan
Email
xianjing@c-luminary.com
Authorized Representative
SRN
DE-AR-000010869
Country
Germany
Address
47 Harffstr. Dรผsseldorf
Email
de.rep@sungoglobal.com
Regulatory Information
Competent Authority
DE/CA20, Bezirksregierung Dรผsseldorf 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
No