Manufacturer

NORMA Instruments Zártkörűen Működő Részvénytársaság

Hungary

Markets : Germany · Hungary

Approvals : EU – class A

6 categories, 20 models including 20 on the market, 1 country

On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
Cbc-reagents (cleaning-/diluting-/lysing-/sheath-fluids)	W0103010105	H3-Compact 100 Norma-iRP313 refs H3/5-Hypoclean2 refs H5-Compact 100 Norma-iRP513 refs H5-Compact 100-O Norma-iRP51 OP3 refs H5-Opticlean2 refs 7 others Norma-iClean5 Norma-iDil3 Norma-iDil5 Norma-iLyse3 Norma-iLyse5 Norma-iRP20 Norma-iRP212 refs Norma-iSol32 refs	A IVDR	EUDAMED record Report an error
Automated 3 part hematology analysers	W0202010201	Hemolyzer® 3 NG automated 3-part differential hematology analyzer Norma Icon-33 refs Norma i3LAB automated 3-part differential hematology analyzer2 refs	A IVDR	EUDAMED record Report an error
Automated whole blood hematology analysers - low routine (throughput <= 100 samples/hr)	W0202010101	Hemolyzer® 5 NG automated 5-part differential hematology analyzer with closed sampling method Norma Icon-53 refs Hemolyzer® 5 NG Open automated 5-part differential hematology analyzer with open sampling method Norma Icon-5 OP3 refs	A IVDR	EUDAMED record Report an error
Normal blood controls	W0103010501	H3-Check Complete control blood set for 3-part differential Hemolyzer® hematology analyzers - 2 low, 2 normal and 2 high vials NormaCont3+ KIT K13 refs H5-Check Complete control blood set for 5-part differential Hemolyzer® hematology analyzers - 2 low, 2 normal and 2 high vials NormaCont5+ control blood set for 5-part differential hematology analyzers3 refs	A IVDR	EUDAMED record Report an error
Automated sample transport systems	W02060102	Autosampler NG accessory unit for automated sample vial loading3 refs	A IVDR	EUDAMED record Report an error
Whole blood calibrators	W0103010507	H3/5-CAL calibrator for Hemolyzer® hematology analyzers NormaCal3 calibrator2 refs	A IVDR	EUDAMED record Report an error

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