EUDAMED registration 06975070765477NoFully Atomated CLIA Analyzer
- Risk class
- Class A
- CND nomenclatures code
- W02020699
- Trade name
- Fully Automated CLIA Analyzer
- Implantable
- No
- Reusable
- No
- Measuring function
- No
- Primary DI
- 06975070765477
- Basic UDI
- 697507076CLSharay8000GV
- Version date
- August 27, 2024
- Manufacturer last update
- April 25, 2023
- Active status
- No
- Manufacturer name
- C-Luminary Biotechnology Co., Ltd.
- Country
- China
- Country type
- NON_EU
- Address
- Building #3, No. 6, Xixin Avenue, High-tech zone, Chengdu, Sichuan
- xianjing@c-luminary.com
- Name
- Sungo Cert GmbH
- SRN
- DE-AR-000010869
- Country
- Germany
- Address
- 47 Harffstr. Düsseldorf
- de.rep@sungoglobal.com
- 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
- Human tissues
- No
- Animal tissues
- No
RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER
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 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.