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Chemiluminescence Analyzer Reaction Cuvettes - EUDAMED Registration 06950617423454

Access comprehensive regulatory information for Chemiluminescence Analyzer Reaction Cuvettes 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 06950617423454 and manufactured by Maccura Biotechnology Co., Ltd. in China.

This page provides complete registration details including trade name (Chemiluminescence Analyzer Reaction Cuvettes), 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
06950617423454
No
Chemiluminescence Analyzer Reaction Cuvettes
Trade Name: Chemiluminescence Analyzer Reaction Cuvettes
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Device Description (EMDN)

SAMPLES ANALYSES, PLASTIC CUVETTES

Device Classification
Risk Class
Class A
CND Nomenclatures Code
W0503010203
Trade Name
Chemiluminescence Analyzer Reaction Cuvettes
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06950617423454
Basic UDI
69506174IM440465E4
Version Date
February 14, 2025
Manufacturer Last Update
November 23, 2023
Active Status
No
Manufacturer
Country
China
Country Type
NON_EU
Address
16#, Baichuan Road, Hi-tech Zone, Chengdu
Email
maccura@maccura.com
Authorized Representative
SRN
NL-AR-000001490
Country
Netherlands
Address
701 Joop Geesinkweg Amsterdam-Duivendrech
Email
ce-tech@humiss.com
Telephone
+31 (0)20 369 8116
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
Türkiye
Market Available
Austria:None~None, Belgium:None~None, Bulgaria:None~None, Croatia:None~None, Cyprus:None~None, Czechia:None~None, Denmark:None~None, Estonia:None~None, Finland:None~None, France:None~None, Germany:None~None, Greece:None~None, Hungary:None~None, Iceland:None~None, Ireland:None~None, Italy:None~None, Latvia:None~None, Liechtenstein:None~None, Lithuania:None~None, Luxembourg:None~None, Malta:None~None, Netherlands:None~None, Norway:None~None, Poland:None~None, Portugal:None~None, Romania:None~None, Slovakia:None~None, Slovenia:None~None, Spain:None~None, Sweden:None~None, Türkiye:None~None, United Kingdom (Northern Ireland only):None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No