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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 Autoloader accessory unit… — IVDR Class A IVDR

MD Atlas
NORMA Instruments Zártkörűen Működő Részvénytársaság

EUDAMED last updated this device on Feb 6, 2024

Norma Autoloader accessory unit for automated sample vial loading

59991062AutoloaderGH

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: 05999106200047
Reference / catalog number: NICA-AL50

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Manufacturer information

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

Critical warnings

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

CW008
BIOHAZARD Risk of biological infection, contamination
CW011
WARNING – Risk of personal injury AUTOMATIC START-UP – Unexpectedly moving parts

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 Autoloader accessory unit for automated sample vial loading
UDI-DI code: 05999106200047
Basic UDI-DI: 59991062AutoloaderGH
Reference / catalog number: NICA-AL50
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: Norma Autoloader can be used with a Norma Icon-5 and i3LAB automated hematology analyzers with closed sample vial opening. The Autoloader is designed to further automate the operation of the analyzer by allowing the processing of up to 50 sample vials without operator interaction.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W02060102AUTOMATED SAMPLE TRANSPORT SYSTEMS

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.