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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

Hemolyzer® 5 NG Open automated… — IVDR Class A IVDR

MD Atlas
NORMA Instruments Zártkörűen Működő Részvénytársaság

EUDAMED last updated this device on Feb 6, 2024

Hemolyzer® 5 NG Open automated 5-part differential hematology analyzer with open sampling method

59991062Icon5OPU7

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: 05999106200436
Reference / catalog number: HE5200

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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.

CW008
BIOHAZARD Risk of biological infection, contamination
CW013
LASER RADIATION Risk of exposure to laser radiation
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: Hemolyzer® 5 NG Open automated 5-part differential hematology analyzer with open sampling method
UDI-DI code: 05999106200436
Basic UDI-DI: 59991062Icon5OPU7
Reference / catalog number: HE5200
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: Hemolyzer 5 NG is a 57 tests/hour laser and impedance based IVD hematology analyzer for laboratory use, using specific reagents, performing 5-part differential analysis of 27 parameters of anti-coagulated human whole blood samples introduced in open 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

Batch number
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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.