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Organization name
UDI-DI code
Reference / catalog number

NormaCal3 calibrator for Norma… — IVDR Class A IVDR

MD Atlas
NORMA Instruments Zártkörűen Működő Részvénytársaság

EUDAMED last updated this device on Feb 6, 2024

NormaCal3 calibrator for Norma hematology analyzers

59991062NormaCalZ8

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: NORMA Instruments Zártkörűen Működő Részvénytársaság
UDI-DI code: 05999106200207
Reference / catalog number: NIC-CAL32

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Manufacturer information

Organization name: NORMA Instruments Zártkörűen Működő Részvénytársaság
SRN: HU-MF-000014244
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW008
POTENTIAL BIOHAZARDOUS MATERIAL.

Market distribution

Primary placement in Hungary; available across 1 country total.

Placed on the market in Hungary; per-country availability dates not published.

Device identification

Trade name: NormaCal3 calibrator for Norma hematology analyzers
UDI-DI code: 05999106200207
Basic UDI-DI: 59991062NormaCalZ8
Reference / catalog number: NIC-CAL32
Issuing entity: GS1

Classification

Risk category: IVDR Class A
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: NormaCal3 is designed for use in the calibration of Norma hematology analyzers. Please refer to the assay table for specific instrument models.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0103010507WHOLE BLOOD CALIBRATORS

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
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Software identification

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Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.