DX-MIDI3-B0500CCAA

Organization name

3DHISTECH Kft.

SRN

HU-MF-000014337

Manufacturer status

Active

Primary placement in Hungary; available across 32 countries total.

Trade name

not provided

UDI-DI code

05999571470273

Basic UDI-DI

599957147MID3UX

Reference / catalog number

DX-MIDI3-B0500CCAA

Issuing entity

GS1

Risk category

IVDR Class A

Applicable legislation

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

The scanner is a diagnostic purpose in vitro medical device, a digital slide microscope that automatically creates a digital image of the inserted glass slides (such as surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue, cytology smear/specimen, peripheral blood smear, HE (hematoxylin-eosin-stained) tissue, IHC labeled tissue, or frozen section) used by a qualified health professional (pathologist). The scanner digitalises biological samples which are prepared to standard 25 mm wide slide. The dimension standard of the slide is ISO 8037-1. The digital microscope can be part of the diagnostic Pathology Management System, used by a trained healthcare professional (qualified pathologist), for qualitative, visual evaluation or quantitative analysis of digitised pathological specimens. It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images obtained using the system.

Additional information URL

https://www.3dhistech.com/

Clinical sizes

No clinical sizes registered for this device.

• W0202050304DIGITAL LABORATORY MICROSCOPES

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