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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

PANNORAMIC 480 DX Digital Scanner — IVDR Class A IVDR

MD Atlas
3DHISTECH Kft.

EUDAMED last updated this device on Mar 9, 2023

PANNORAMIC 480 DX Digital Scanner

599957147036S5

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: 3DHISTECH Kft.
UDI-DI code: 05999571470365
Reference / catalog number: DX-04801-B1200AAAA

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Manufacturer information

Organization name: 3DHISTECH Kft.
SRN: HU-MF-000014337
Manufacturer status: Active

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: PANNORAMIC 480 DX Digital Scanner
UDI-DI code: 05999571470365
Basic UDI-DI: 599957147036S5
Reference / catalog number: DX-04801-B1200AAAA
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: The scanner is a digital slide microscope that automatically creates a digital image of the inserted glass slides. The digital microscope can be part of the diagnostic Pathology Management System, it uses barcode-based slide recognition and communication to identify the slides (with the CaseManager DX report inventory system). The Pathology Management System is intended to be used to analyze and evaluate pathological specimens, and this product assists the pathologist in reviewing and interpreting digital images of a surgical pathology (histology) study that includes PANNORAMIC® 480 DX Digital Scanner. Digital slides can be displayed, reviewed and analyzed using the slide viewer and image analysis module of CaseManager DX. 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.

EMDN nomenclature code(s)

W0202050304DIGITAL LABORATORY MICROSCOPES

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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Manufacturing date
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Software identification

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On the market

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.