EUDAMED update: Jan 28, 2025

NORMA Instruments Zártkörűen Működő Részvénytársaság

HU-MF-000014244

Active56 devices

Address: Papírgyár, 58. 1038 Budapest
Role: Manufacturer
Date of registration: Oct 11, 2021
Country: Hungary

NORMA Instruments Zártkörűen Működő Részvénytársaság is a medical device manufacturer registered in EUDAMED. The company has 56 devices on the EU market across 2 countries. Headquartered in Budapest, Hungary. Explore the regulatory profile, devices and certificates on MD Atlas.

About NORMA Instruments Zrt.

: HU-MF-000014244
Role: Manufacturer
Country: Hungary
Organization name: NORMA Instruments Zártkörűen Működő Részvénytársaság
EU VAT number: HU24742159
EORI: HU0025664669
Trade register: 01 10 140339
Date of registration: Oct 11, 2021

Contact details for NORMA Instruments Zrt.

Email: arpad.gyetvai@normadiagnostika.com
Address: 58., PAPÍRGYÁR 1038 BUDAPEST HUNGARY

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Competent authority

Name: Nemzeti Népegészségügyi és Gyógyszerészeti Központ

Phone: +36 1 886 9300
Email: amd@nngyk.gov.hu

Officers and regulatory representatives of NORMA Instruments Zrt.

GYETVAI Árpád
PRRC feladatkör ellátása, tehát a szabályoknak való megfelelés biztosításáért felelős személyként felel az IVDR 15. cikkben meghatározott követelményeknek: az eszközök megfelelőségét az eszközök gyártása során alkalmazott minőségirányítási rendszer keretében szabályszerűen ellenőrizték az eszközök szabad forgalomba bocsátását megelőzően. A PRRC feladatkörét lásd a csatolt "Munkaköri leírás" dokumentumban.
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Product	Trade name	Reference / catalog number	Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →	Quantity	Status
Autosampler NG accessory unit for automated sample vial loading	Autosampler NG accessory unit for automated sample vial loading	`HE0350`	`05999106200443`	1	On the market
H3-Check Complete control blood set for 3-part differential Hemolyzer® hematology analyzers - 2 low, 2 normal and 2 high vials	H3-Check Complete control blood set for 3-part differential Hemolyzer® hematology analyzers - 2 low, 2 normal and 2 high vials	`HE3504`	`05999106200535`	1	On the market
H3-Check Normal control blood set for 3-part differential Hemolyzer® hematology analyzers - 6 normal vials	H3-Check Normal control blood set for 3-part differential Hemolyzer® hematology analyzers - 6 normal vials	`HE3505`	`05999106200542`	1	On the market
H3-Compact 100	H3-Compact 100	`HE3701`	`05999106200450`	1	On the market
H3-Compact 500	H3-Compact 500	`HE3705`	`05999106200467`	1	On the market
H3/5-CAL calibrator for Hemolyzer® hematology analyzers	H3/5-CAL calibrator for Hemolyzer® hematology analyzers	`HE3611`	`05999106200573`	1	On the market
H3/5-Hypoclean	H3/5-Hypoclean	`HE3413`	`05999106200511`	1	On the market
H3/5-Hypoclean	H3/5-Hypoclean	`HE3413`	`05999106200849`	1	On the market
H5-Check Complete control blood set for 5-part differential Hemolyzer® hematology analyzers - 2 low, 2 normal and 2 high vials	H5-Check Complete control blood set for 5-part differential Hemolyzer® hematology analyzers - 2 low, 2 normal and 2 high vials	`HE5504`	`05999106200559`	1	On the market
H5-Check Normal control blood set for 5-part differential Hemolyzer® hematology analyzers - 6 normal vials	H5-Check Normal control blood set for 5-part differential Hemolyzer® hematology analyzers - 6 normal vials	`HE5505`	`05999106200566`	1	On the market
H5-Compact 100	H5-Compact 100	`HE5701`	`05999106200474`	1	On the market
H5-Compact 100-O	H5-Compact 100-O	`HE5707`	`05999106200498`	1	On the market
H5-Compact 250-O	H5-Compact 250-O	`HE5709`	`05999106200504`	1	On the market
H5-Compact 400	H5-Compact 400	`HE5704`	`05999106200481`	1	On the market
H5-Opticlean	H5-Opticlean	`HE3422`	`05999106200856`	1	On the market
H5-Opticlean	H5-Opticlean	`HE3422`	`05999106200528`	1	On the market
Hemolyzer® 3 NG automated 3-part differential hematology analyzer	Hemolyzer® 3 NG automated 3-part differential hematology analyzer	`HE3100`	`05999106200412`	1	On the market
Hemolyzer® 5 NG automated 5-part differential hematology analyzer with closed sampling method	Hemolyzer® 5 NG automated 5-part differential hematology analyzer with closed sampling method	`HE5100`	`05999106200429`	1	On the market
Hemolyzer® 5 NG Open automated 5-part differential hematology analyzer with open sampling method	Hemolyzer® 5 NG Open automated 5-part differential hematology analyzer with open sampling method	`HE5200`	`05999106200436`	1	On the market
Norma Autoloader accessory unit for automated sample vial loading	Norma Autoloader accessory unit for automated sample vial loading	`NICA-AL50`	`05999106200047`	1	On the market
Norma i3LAB automated 3-part differential hematology analyzer	Norma i3LAB automated 3-part differential hematology analyzer	`NI31H`	`05999106200351`	1	On the market
Norma Icon-3 automated 3-part differential hematology analyzer	Norma Icon-3 automated 3-part differential hematology analyzer	`NI30H`	`05999106200009`	1	On the market
Norma Icon-5 automated 5-part differential hematology analyzer with closed sampling method	Norma Icon-5 automated 5-part differential hematology analyzer with closed sampling method	`NI50H`	`05999106200016`	1	On the market
Norma Icon-5 OP automated 5-part differential hematology analyzer with open sampling method	Norma Icon-5 OP automated 5-part differential hematology analyzer with open sampling method	`NO50H`	`05999106200023`	1	On the market
Norma-iClean5	Norma-iClean5	`IC-51755`	`05999106200337`	1	On the market

Product	Trade name	Reference / catalog number	Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →	Quantity	Status
Autosampler NG accessory unit for automated sample vial loading	Autosampler NG accessory unit for automated sample vial loading	`HE0350`	`05999106200443`	1	On the market
H3-Check Complete control blood set for 3-part differential Hemolyzer® hematology analyzers - 2 low, 2 normal and 2 high vials	H3-Check Complete control blood set for 3-part differential Hemolyzer® hematology analyzers - 2 low, 2 normal and 2 high vials	`HE3504`	`05999106200535`	1	On the market
H3-Check Normal control blood set for 3-part differential Hemolyzer® hematology analyzers - 6 normal vials	H3-Check Normal control blood set for 3-part differential Hemolyzer® hematology analyzers - 6 normal vials	`HE3505`	`05999106200542`	1	On the market
H3-Compact 100	H3-Compact 100	`HE3701`	`05999106200450`	1	On the market
H3-Compact 500	H3-Compact 500	`HE3705`	`05999106200467`	1	On the market
H3/5-CAL calibrator for Hemolyzer® hematology analyzers	H3/5-CAL calibrator for Hemolyzer® hematology analyzers	`HE3611`	`05999106200573`	1	On the market
H3/5-Hypoclean	H3/5-Hypoclean	`HE3413`	`05999106200511`	1	On the market
H3/5-Hypoclean	H3/5-Hypoclean	`HE3413`	`05999106200849`	1	On the market
H5-Check Complete control blood set for 5-part differential Hemolyzer® hematology analyzers - 2 low, 2 normal and 2 high vials	H5-Check Complete control blood set for 5-part differential Hemolyzer® hematology analyzers - 2 low, 2 normal and 2 high vials	`HE5504`	`05999106200559`	1	On the market
H5-Check Normal control blood set for 5-part differential Hemolyzer® hematology analyzers - 6 normal vials	H5-Check Normal control blood set for 5-part differential Hemolyzer® hematology analyzers - 6 normal vials	`HE5505`	`05999106200566`	1	On the market
H5-Compact 100	H5-Compact 100	`HE5701`	`05999106200474`	1	On the market
H5-Compact 100-O	H5-Compact 100-O	`HE5707`	`05999106200498`	1	On the market
H5-Compact 250-O	H5-Compact 250-O	`HE5709`	`05999106200504`	1	On the market
H5-Compact 400	H5-Compact 400	`HE5704`	`05999106200481`	1	On the market
H5-Opticlean	H5-Opticlean	`HE3422`	`05999106200856`	1	On the market
H5-Opticlean	H5-Opticlean	`HE3422`	`05999106200528`	1	On the market
Hemolyzer® 3 NG automated 3-part differential hematology analyzer	Hemolyzer® 3 NG automated 3-part differential hematology analyzer	`HE3100`	`05999106200412`	1	On the market
Hemolyzer® 5 NG automated 5-part differential hematology analyzer with closed sampling method	Hemolyzer® 5 NG automated 5-part differential hematology analyzer with closed sampling method	`HE5100`	`05999106200429`	1	On the market
Hemolyzer® 5 NG Open automated 5-part differential hematology analyzer with open sampling method	Hemolyzer® 5 NG Open automated 5-part differential hematology analyzer with open sampling method	`HE5200`	`05999106200436`	1	On the market
Norma Autoloader accessory unit for automated sample vial loading	Norma Autoloader accessory unit for automated sample vial loading	`NICA-AL50`	`05999106200047`	1	On the market
Norma i3LAB automated 3-part differential hematology analyzer	Norma i3LAB automated 3-part differential hematology analyzer	`NI31H`	`05999106200351`	1	On the market
Norma Icon-3 automated 3-part differential hematology analyzer	Norma Icon-3 automated 3-part differential hematology analyzer	`NI30H`	`05999106200009`	1	On the market
Norma Icon-5 automated 5-part differential hematology analyzer with closed sampling method	Norma Icon-5 automated 5-part differential hematology analyzer with closed sampling method	`NI50H`	`05999106200016`	1	On the market
Norma Icon-5 OP automated 5-part differential hematology analyzer with open sampling method	Norma Icon-5 OP automated 5-part differential hematology analyzer with open sampling method	`NO50H`	`05999106200023`	1	On the market
Norma-iClean5	Norma-iClean5	`IC-51755`	`05999106200337`	1	On the market

NORMA Instruments Zártkörűen Működő Részvénytársaság

About NORMA Instruments Zrt.

Contact details for NORMA Instruments Zrt.

Export the 56 devices of NORMA Instruments Zrt.

Competent authority

Officers and regulatory representatives of NORMA Instruments Zrt.

Related searches

About NORMA Instruments Zrt.

Contact details for NORMA Instruments Zrt.

Export the 56 devices of NORMA Instruments Zrt.

Competent authority

Officers and regulatory representatives of NORMA Instruments Zrt.

Statistics for NORMA Instruments Zrt.

Certificate health for NORMA Instruments Zrt.

Devices by risk class

Market presence of NORMA Instruments Zrt.

Device catalog for NORMA Instruments Zrt.

Device families (Basic UDI-DI) of NORMA Instruments Zrt.

Related searches

Certificate health for NORMA Instruments Zrt.

Statistics for NORMA Instruments Zrt.

Market presence of NORMA Instruments Zrt.

Devices by risk class

Device families (Basic UDI-DI) of NORMA Instruments Zrt.

Device catalog for NORMA Instruments Zrt.