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Emdyca

Manufacturer

Diatron

HungaryLegal entities : Diatron Medicinai Instrumentumok Laboratóriumi Diagnosztikai Fejlesztő-Gyártó Zártkörűen Működő Részvénytársaság

Markets : Hungary · United States

Approvals : EU – class A · United States (FDA) – 510(k) : 6 · class II · latest in 2020 · see on the FDA website

Website

10 categories, 27 models including 27 on the market, 1 country

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CategoryEMDN codeRegistered modelsClassContact
Cbc-reagents (cleaning-/diluting-/lysing-/sheath-fluids) W0103010105
4 others
 A IVDR, 98/79 EUDAMED record Report an error
Abnormal blood controls W0103010502 – 98/79 EUDAMED record Report an error
Automated 3 part hematology analysers W0202010201 A IVDR EUDAMED record Report an error
IVD general use consumable devices - other W0599 A IVDR EUDAMED record Report an error
Multilevel blood controls W0103010503 – 98/79 EUDAMED record Report an error
Normal blood controls W0103010501 – 98/79 EUDAMED record Report an error
Automated whole blood hematology analysers - low routine (throughput <= 100 samples/hr) W0202010101 A IVDR 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 routine (with ise mode test/h > 400 and <= 800) W0201010106 A IVDR EUDAMED record Report an error
Whole blood calibrators W0103010507 – 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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