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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

5 Hematology Scope — IVDR Class A IVDR by Diatron Medicinai…

MD Atlas
Diatron Medicinai Instrumentumok Laboratóriumi Diagnosztikai Fejlesztő-Gyártó Zártkörűen Működő Részvénytársaság

EUDAMED last updated this device on Oct 9, 2024

5 Hematology Scope

5999883586A5XW

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Diatron Medicinai Instrumentumok Laboratóriumi Diagnosztikai Fejlesztő-Gyártó Zártkörűen Működő Részvénytársaság
UDI-DI code: 65999883586015
Reference / catalog number: DATR5PA5-AV

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Manufacturer information

Organization name: Diatron Medicinai Instrumentumok Laboratóriumi Diagnosztikai Fejlesztő-Gyártó Zártkörűen Működő Részvénytársaság
SRN: HU-MF-000020416
Manufacturer status: Active

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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.

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.

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: 5 Hematology Scope
UDI-DI code: 65999883586015
Basic UDI-DI: 5999883586A5XW
Reference / catalog number: DATR5PA5-AV
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: 5 Hematology Scope automated hematology analyzer for in vitro determinations
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

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