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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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NormaCal3 calibrator for Norma… — 2 UDI-DI variants, IVDR

MD Atlas
NORMA Instruments Zártkörűen Működő Részvénytársaság

Data from EUDAMED, last updated May 24, 2026

NormaCal3 calibrator for Norma hematology analyzers

59991062NormaCalZ8

2 UDI-DI variants

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]IVDR Class A

Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class A
Manufacturer: NORMA Instruments Zártkörűen Működő Részvénytársaság

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Device characteristics

ReagentProfessional testingHuman tissues / cellsAnimal tissues / cells

Identity & classification

Basic UDI-DI: 59991062NormaCalZ8
Device name: NormaCal3 calibrator for Norma hematology analyzers
Device model: NormaCal3 calibrator
Issuing agency: GS1
Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class A
Version date: Feb 24, 2025

Manufacturer & authorised representative

Manufacturer

Name: NORMA Instruments Zártkörűen Működő Részvénytársaság
SRN: HU-MF-000014244
Country: Hungary
Email: arpad.gyetvai@normadiagnostika.com

Variants by status

UDI-DI variants

2 UDI-DI variants

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basicUdiUlid01HNZ9ZBF0SNGB57BFNQQP8PYK

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Summary

29 columns included

Trade name
Basic UDI-DI
UDI-DI code
Risk category
Applicable legislation
Status
Organization name
SRN
Reference / catalog number
Additional product description
Intended medical purpose
Placed on the market (country)
Market info update date
Sterile
Single use
Contains latex
Reprocessed single-use
Direct marking
CMR substance
Endocrine disruptor
Annex XVI applicable
Sterilization
OEM applicable
EMDN codes
Last updated
Basic UDI-DI device name
Basic UDI-DI device model
Basic UDI-DI implantable
Basic UDI-DI reagent

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NormaCal3 calibrator for Norma hematology analyzers05999106200207