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Microbiology Platform Product Family - EUDAMED Registration 15099590792930

Access comprehensive regulatory information for Microbiology Platform Product Family 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 15099590792930 and manufactured by Beckman Coulter Inc. in United States.

This page provides complete registration details including trade name (MicroScan LabPro V4_V5 Maintenance Update 05 DVD Kit), manufacturer information, authorized representative details, competent authority (Health Products Regulatory Authority, Medical Devices Department), 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
15099590792930
No
Microbiology Platform Product Family
Trade Name: MicroScan LabPro V4_V5 Maintenance Update 05 DVD Kit
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Device Description (EMDN)

ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - SOFTWARE ACCESSORIES

Device Classification
Risk Class
Class A
CND Nomenclatures Code
W0203010182
Trade Name
MicroScan LabPro V4_V5 Maintenance Update 05 DVD Kit
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
15099590792930
Basic UDI
15099501MCSWMN
Version Date
March 20, 2024
Manufacturer Last Update
July 21, 2021
Active Status
No
Manufacturer
Manufacturer Name
Beckman Coulter Inc.
Country
United States
Country Type
NON_EU
Address
250 S Kraemer Blvd Brea, CA
Email
BECFA@beckman.com
Authorized Representative
SRN
IE-AR-000000886
Country
Ireland
Address
Lismeehan Clare
Email
ra.clare@beckman.com
Telephone
+353 65 6831100
Regulatory Information
Competent Authority
Health Products Regulatory Authority, Medical Devices Department
Applicable Legislation
IVDR (REGULATION (EU) 2017/746 on in vitro diagnostic medical devices)
Placed On The Market
Ireland
Market Available
Belgium:None~None, Bulgaria:None~None, Czechia:None~None, France:None~None, Germany:None~None, Greece:None~None, Ireland:None~None, Italy:None~None, Netherlands:None~None, Norway:None~None, Poland:None~None, Portugal:None~None, Romania:None~None, Spain:None~None, United Kingdom (Northern Ireland only):None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No