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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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Organization name
UDI-DI code
Reference / catalog number

Norma Icon-5 automated 5-part… — IVDR Class A IVDR

MD Atlas
NORMA Instruments Zártkörűen Működő Részvénytársaság

EUDAMED last updated this device on Feb 6, 2024

Norma Icon-5 automated 5-part differential hematology analyzer with closed sampling method

59991062Icon5A6

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: 05999106200016
Reference / catalog number: NI50H

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Manufacturer information

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

Critical warnings

3 warnings recorded — scroll inside the panel to see all entries.

CW013
LASER RADIATION Class 1 laser product
CW008
BIOHAZARD Risk of biological infection, contamination
CW999
WARNING Risk of personal injury

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: Norma Icon-5 automated 5-part differential hematology analyzer with closed sampling method
UDI-DI code: 05999106200016
Basic UDI-DI: 59991062Icon5A6
Reference / catalog number: NI50H
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: Icon-5 is a 60 tests/hour laser scattering and impedance-based IVD hematology analyzer for laboratory use, using specific reagents, performing 5-part differential analysis of 27 hematology parameters of anti-coagulated human whole blood samples introduced in closed vials.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0202010101AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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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.