NORMA Instruments Zártkörűen Működő Részvénytársaság

SRN: HU-MF-000014244 · Papírgyár 58., 1038 Budapest, Hungary

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Basic UDI-DIs

Total Devices

On Market

Off Market

Certificates

Valid

Expiring < 6mo

Countries

Basic Information

Address: Papírgyár 58., 1038 Budapest, Hungary
Email: [email protected]

Regulatory Overview

Regulation

Eu Ivdr 9

Classification

Eu Ivd Class A 9

Device Types

Certificate Health

No certificates registered for this manufacturer.

Device Portfolio

Name	Regulation	Classification	Market Status
AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)	EU IVDR	Eu Ivd Class A	Not EU
AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)	EU IVDR	Eu Ivd Class A	Not EU
Autosampler NG accessory unit for automated sample vial loading	EU IVDR	Eu Ivd Class A	On Market
H3-Check Complete control blood set for 3-part differential Hemolyzer® hematology analyzers - 2 low, 2 normal and 2 high vials	EU IVDR	Eu Ivd Class A	On Market
H3-Check Normal control blood set for 3-part differential Hemolyzer® hematology analyzers - 6 normal vials	EU IVDR	Eu Ivd Class A	On Market
H3/5-CAL calibrator for Hemolyzer® hematology analyzers	EU IVDR	Eu Ivd Class A	On Market
H5-Check Complete control blood set for 5-part differential Hemolyzer® hematology analyzers - 2 low, 2 normal and 2 high vials	EU IVDR	Eu Ivd Class A	On Market
H5-Check Normal control blood set for 5-part differential Hemolyzer® hematology analyzers - 6 normal vials	EU IVDR	Eu Ivd Class A	On Market
Hemolyzer® 3 NG automated 3-part differential hematology analyzer	EU IVDR	Eu Ivd Class A	On Market
Hemolyzer® 5 NG Open automated 5-part differential hematology analyzer with open sampling method	EU IVDR	Eu Ivd Class A	On Market
Hemolyzer® 5 NG automated 5-part differential hematology analyzer with closed sampling method	EU IVDR	Eu Ivd Class A	On Market
Norma Autoloader accessory unit for automated sample vial loading	EU IVDR	Eu Ivd Class A	On Market
Norma Autoloader demo accessory unit for automated sample vial loading	EU IVDR	Eu Ivd Class A	Not EU
Norma Icon-3 automated 3-part differential hematology analyzer	EU IVDR	Eu Ivd Class A	On Market
Norma Icon-3 demo automated 3-part differential hematology analyzer	EU IVDR	Eu Ivd Class A	Not EU
Norma Icon-5 OP automated 5-part differential hematology analyzer with open sampling method	EU IVDR	Eu Ivd Class A	On Market
Norma Icon-5 automated 5-part differential hematology analyzer with closed sampling method	EU IVDR	Eu Ivd Class A	On Market
Norma i3LAB automated 3-part differential hematology analyzer	EU IVDR	Eu Ivd Class A	On Market
Norma i3LAB demo automated 3-part differential hematology analyzer	EU IVDR	Eu Ivd Class A	Not EU
Norma-iDil5	EU IVDR	Eu Ivd Class A	On Market
NormaCal3 calibrator for Norma hematology analyzers	EU IVDR	Eu Ivd Class A	On Market
NormaCont3+ KIT K1 control blood set for 3-part differential Norma hematology analyzers - 2 low, 2 normal and 2 high vials	EU IVDR	Eu Ivd Class A	On Market
NormaCont3+ KIT KH control blood set for 3-part differential Norma hematology analyzers - 6 high vials	EU IVDR	Eu Ivd Class A	On Market
NormaCont3+ KIT KL control blood set for 3-part differential Norma hematology analyzers - 6 low vials	EU IVDR	Eu Ivd Class A	On Market
NormaCont3+ KIT KN control blood set for 3-part differential Norma hematology analyzers - 6 normal vials	EU IVDR	Eu Ivd Class A	On Market
NormaCont5+ KIT K1 control blood set for 5-part differential Norma hematology analyzers - 2 low, 2 normal and 2 high vials	EU IVDR	Eu Ivd Class A	On Market
NormaCont5+ KIT KH control blood set for 5-part differential Norma hematology analyzers - 6 high vials	EU IVDR	Eu Ivd Class A	On Market
NormaCont5+ KIT KL control blood set for 5-part differential Norma hematology analyzers - 6 low vials	EU IVDR	Eu Ivd Class A	On Market
NormaCont5+ KIT KN control blood set for 5-part differential Norma hematology analyzers - 6 normal vials	EU IVDR	Eu Ivd Class A	On Market