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Beckman Coulter Inc. - Manufacturer Profile

Explore comprehensive manufacturer profile for Beckman Coulter Inc. through Pure Global AI's free EU medical device database. This company manufactures 1143 medical devices registered with EUDAMED across 6 risk classes based in United States.

This page provides detailed insights including recent registrations, risk class distribution (Class C: 100, Class A: 192, IVD General: 520, IVD Annex II List B: 38, IVD Annex II List A: 13, ...), and complete regulatory information from the official EU EUDAMED medical device database. Pure Global AI offers free access to the European Union's complete medical device registry.

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1143 Devices
6 Risk Classes
Beckman Coulter Inc.
Manufacturer - United States
1143
Total Devices
6
Risk Classes
2022
Earliest Version
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Recent Products (Latest 10)
Most recently updated devices in the database
Device NameRisk ClassDetail
Microbiology Platform Product Family
Class A
IMMAGE Immunochemistry Systems PAB Prealbumin Reagent
Class B
IMMAGE Immunochemistry Systems CSF-CAL Cerebrospinal Fluid Protein Calibrator
Class B
Immunochemistry Systems CAL 2 Calibrator 2
Class B
Access Free T4
Class B
Microbiology Platform Product Family
Class A
Microbiology Platform Product Family
Class A
Vigil Serology Control Level 1
Class C
Vigil Serology Control Level C
Class C
Vigil Serology Control Level 3
Class C
Risk Class Distribution
Breakdown by risk classification
IVD General
520(45.5%)
Class B
280(24.5%)
Class A
192(16.8%)
Class C
100(8.7%)
IVD Annex II List B
38(3.3%)
IVD Annex II List A
13(1.1%)
Top Authorized Representatives
Most common authorized representatives for this manufacturer
Authorized RepresentativeDevice CountPercentageView
Beckman Coulter Ireland Inc.
1143100.0%