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Emdyca

Manufacturer

Beckman Coulter

China, Germany, Ireland, Japan, United StatesLegal entities : Beckman Coulter Biomedical GmbH, Beckman Coulter Biotechnology Co., Ltd., Beckman Coulter Inc.

First countries of placing on the market declared in EUDAMED : Austria, Belgium, Germany, Ireland, Netherlands, Northern Ireland, Spain

Public contracts won : France 23, Italy 20, Croatia 11, Germany 4, Sweden 3, Poland 1

EU representative : Beckman Coulter Ireland Inc. (Ireland)

Website ra.clare@beckman.com

70 categories, 356 models including 355 on the market, 5 countries

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CategoryEMDN codeRegistered modelsClassContact
Antibiotic susceptibility analysers - consumables W0203010185
70 others
A, B IVDR, 98/79 EUDAMED record Report an error
Monoclonal antibodies for cell surface antigens - other W0103080199
30 others
– 98/79 EUDAMED record Report an error
Flow cytometry controls - other W0103080499
14 others
C IVDR, 98/79 EUDAMED record Report an error
Samples transport, containers - accessories W05020180
10 others
A IVDR EUDAMED record Report an error
Antibodies for b and t-cell subtyping W0103080101
9 others
C IVDR, 98/79 EUDAMED record Report an error
Haematology controls - other W0103010599
8 others
– 98/79 EUDAMED record Report an error
Automated whole blood hematology analysers - low routine (throughput <= 100 samples/hr) W0202010101
4 others
– 98/79 EUDAMED record Report an error
Automated whole blood hematology analysers - consumables W0202010185
3 others
A IVDR EUDAMED record Report an error
Reagents for flow cytometry - other W0103080699
3 others
A IVDR EUDAMED record Report an error
Setup beads W0103080401
3 others
A, C IVDR, 98/79 EUDAMED record Report an error
Urinalysis (ur) - laboratory analysers- instruments W02010701
3 others
– 98/79 EUDAMED record Report an error
Antibiotic susceptibility analysers - IVD medical device software W0203010192
2 others
B IVDR, 98/79 EUDAMED record Report an error
Antibiotic susceptibility analysers - software accessories W0203010182
2 others
A IVDR, 98/79 EUDAMED record Report an error
Lymphocyte subtyping controls W0103080403
2 others
C IVDR, 98/79 EUDAMED record Report an error
Antibodies for lymphocyte subtyping W0103080106
1 other
C IVDR, 98/79 EUDAMED record Report an error
Auxiliary & supplemental reagents for flow cytometry - other W0103080599
1 other
C IVDR, 98/79 EUDAMED record Report an error
Centrifuges W02069003
1 other
A IVDR EUDAMED record Report an error
Blood grouping analysers - consumables W0202030185 A IVDR EUDAMED record Report an error
Chemistry analysers - hardware accessories W0201010180 B IVDR EUDAMED record Report an error
Controls - inf. immunology - other W0105080899 – 98/79 EUDAMED record Report an error
Various microbiology instruments - consumables W02039085 A IVDR EUDAMED record Report an error
Whole blood calibrators W0103010507 C IVDR, 98/79 EUDAMED record Report an error
Multilevel blood controls W0103010503 C IVDR, 98/79 EUDAMED record Report an error
Other virology standards and calibrators - inf.imm. W0105080904 – 98/79 EUDAMED record Report an error
Antibiotic susceptibility analysers - hardware accessories W0203010180 A IVDR EUDAMED record Report an error
Automated immunochemistry analysers - moderate to high routine (throughput > 250 and <= 700 test/h) W0201020103 A IVDR EUDAMED record Report an error
Automated systems for the management of pre and post-analysis W02060101 A IVDR EUDAMED record Report an error
Chemistry analysers - consumables W0201010185 A IVDR, 98/79 EUDAMED record Report an error
Chemistry analysers - low routine (random access without ise mode test/h <= 400) W0201010101 A IVDR EUDAMED record Report an error
Chemistry analysers - moderate to high routine (random access without ise mode test/h > 800 and <= 1.200) W0201010103 A IVDR EUDAMED record Report an error
Cytoflowmeters - software accessories W0202040182 A IVDR EUDAMED record Report an error
Hav antibody (total) W0105020102 B IVDR, 98/79 EUDAMED record Report an error
Hepatitis virus standards and calibrators - inf.imm. W0105080902 B IVDR, 98/79 EUDAMED record Report an error
Samples analyses, plastic tubes - accessories W050301020180 A IVDR EUDAMED record Report an error
Automated immunochemistry analysers - moderate routine (throughput > 100 and <= 250 test/h) W0201020102 A IVDR EUDAMED record Report an error
Autosamplers W02069001 A IVDR EUDAMED record Report an error
Hepatitis b surface antigen - confirmatory W0105020202 – 98/79 EUDAMED record Report an error
Hepatitis virus controls - inf.imm. W0105080802 B IVDR EUDAMED record Report an error
Interleukin 6 (il-6) W01030609 C IVDR EUDAMED record Report an error
Various general purpose IVD instruments - consumables W02079085 A IVDR EUDAMED record Report an error
Abnormal blood controls W0103010502 – 98/79 EUDAMED record Report an error
Antibiotic susceptibility analysers - other W02030199 A IVDR EUDAMED record Report an error
Automated immunochemistry analysers - low routine (throughput <= 100 test/h) W0201020101 A IVDR EUDAMED record Report an error
Automated sample transport systems W02060102 A IVDR EUDAMED record Report an error
Automated whole blood hematology analysers - hardware accessories W0202010180 A IVDR EUDAMED record Report an error
Automated whole blood hematology analysers - IVD medical device software W0202010192 – 98/79 EUDAMED record Report an error
Blood grouping instruments - other W02020399 A IVDR EUDAMED record Report an error
Chemistry analysers - high routine (with ise mode test/h > 1.200) W0201010108 A IVDR EUDAMED record Report an error
Chemistry analysers - moderate to high routine (with ise mode test/h > 800 and <= 1.200) W0201010107 A IVDR EUDAMED record Report an error
Cmv igg W0105040203 – 98/79 EUDAMED record Report an error
Cmv igm W0105040204 – 98/79 EUDAMED record Report an error
Cytoflowmeters - hardware accessories W0202040180 A IVDR EUDAMED record Report an error
Cytoflowmeters - moderate routine W0202040102 A IVDR EUDAMED record Report an error
Haemoglobin controls W0103010504 – 98/79 EUDAMED record Report an error
Hav antibody igm W0105020104 – 98/79 EUDAMED record Report an error
Hepatitis b surface antibody igg W0105020204 – 98/79 EUDAMED record Report an error
Hepatitis b surface antigen W0105020201 – 98/79 EUDAMED record Report an error
Microscope slides W0503900201 A IVDR EUDAMED record Report an error
Nucleic acid testing instruments except micro-arrays - consumables W02050185 – 98/79 EUDAMED record Report an error
Reagents for (automated) haematology analyzer - other W0103010199 – 98/79 EUDAMED record Report an error
Reticulocyte controls W0103010506 – 98/79 EUDAMED record Report an error
Robotic sample processing systems - consumables W02060185 A IVDR EUDAMED record Report an error
Robotic sample processing systems - software accessories W02060182 A IVDR EUDAMED record Report an error
Rubella virus igg W0105040102 – 98/79 EUDAMED record Report an error
Rubella virus igm W0105040103 – 98/79 EUDAMED record Report an error
Samples analyses, containers - other W05030199 A IVDR EUDAMED record Report an error
Samples analyses, plastic tubes without additives W050301020102 A IVDR EUDAMED record Report an error
Toxoplasma antibody igg W0105050102 – 98/79 EUDAMED record Report an error
Toxoplasma antibody igm W0105050103 – 98/79 EUDAMED record Report an error
Urinalysis (ur) - laboratory analysers - software accessories W02010782 – 98/79 EUDAMED record Report an error

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

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