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Automatic Chemiluminescence Analyzer - EUDAMED Registration 06972168350140

Access comprehensive regulatory information for Automatic Chemiluminescence 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 06972168350140 and manufactured by Maccura Medical Instrument Co., Ltd. in China.

This page provides complete registration details including trade name (Automatic Chemiluminescence Analyzer), 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
06972168350140
No
Automatic Chemiluminescence Analyzer
Trade Name: Automatic Chemiluminescence Analyzer
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Device Description (EMDN)

AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)

Device Classification
Risk Class
Class A
CND Nomenclatures Code
W0201020102
Trade Name
Automatic Chemiluminescence Analyzer
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06972168350140
Basic UDI
69721683511029R
Version Date
February 21, 2025
Manufacturer Last Update
September 05, 2022
Active Status
No
Manufacturer
Country
China
Country Type
NON_EU
Address
Building 4, 8#, 2nd Anhe Roda, Hi-tech Zone, 611731, Chengdu 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