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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

Case Manager DX — IVDR Class A IVDR by 3DHISTECH Kft.

MD Atlas
3DHISTECH Kft.

EUDAMED last updated this device on Jul 13, 2023

Case Manager DX

599957147155SE

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: 05999571470150
Reference / catalog number: DX-CASEM-0

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Manufacturer information

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

Related devices

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Market distribution

Primary placement in Germany; available across 1 country total.

Placed on the market in Germany; per-country availability dates not published.

Device identification

Trade name: Case Manager DX
UDI-DI code: 05999571470150
Basic UDI-DI: 599957147155SE
Reference / catalog number: DX-CASEM-0
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 CaseManager™ DX Software application, developed by 3DHISTECH, is an in vitro diagnostic (IVD) medical device designed to exchange, identify, store and manage electronic health records, to receive, identify and manage digital images of surgical pathology and cytology slides – digital sections primarily obtained from formalin-fixed paraffin-embedded (FFPE) tissue specimens and cytology samples (vaginal smears) – produced by 3DHISTECH's PANNORAMIC® Diagnostic Scanner Software with one of the four Whole Slide Imaging (WSI) scanners (PANNORAMIC® 1000 DX Digital Scanner; PANNORAMIC® 480 DX Digital Scanner; PANNORAMIC® 250 Flash III DX Digital Scanner; PANNORAMIC® Flash DESK DX Digital Scanner) – and store those in the SlideStorageDX™ module. It links electronic health records and medical images to cases for pathologists in a centralized database. It is intended for use by healthcare professionals (e.g.: qualified pathologists) in clinical laboratory and hospital settings on all individuals without population restrictions. The software provides tools for pathologists to manage the cases, view, interpret and analyze the linked electronic health records and the medical images in the ClinicalViewer™ module, and to write reports, while ensuring that only the relevant electronic health records and digital images can be accessed and utilized for diagnostic purposes. Pathologists using the CaseManager™ DX Software and its modules are responsible for following appropriate procedures and safeguards to ensure the validity of image interpretation. While the software assists in the diagnostic process in conjunction with other clinical and laboratory information, it should not be used as a substitution for the professional judgment of a qualified pathologist.
Additional information URL: https://www.3dhistech.com/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0202050392LABORATORY INSTRUMENTS FOR MICROSCOPIC INVESTIGATIONS - IVD MEDICAL DEVICE SOFTWARE

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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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.