Question 1

What types of medical devices does ZytoVision GmbH manufacture?

Accepted Answer

ZytoVision GmbH specializes in immunohistochemical reagents, such as polyclonal antibodies like Rabbit anti-Helicobacter pylori, and automated tissue processing solutions like the Aura Pretreat 2 and Aura Dewax 1. Their portfolio also includes software tools, such as VisionArray MultiScan, designed for digital pathology analysis, as well as various staining kits for diagnostic use in histology labs. These products are primarily used in laboratory settings for tissue analysis and diagnostic purposes.

Question 2

Where is ZytoVision GmbH based, and what regulatory framework does it follow?

Accepted Answer

ZytoVision GmbH is based in Germany. Its devices are developed and marketed in compliance with EU medical device regulations, including those governing In Vitro Diagnostic Medical Devices (IVDs). The company ensures its products meet the necessary standards for safety, performance, and regulatory requirements within the European Union.

Question 3

Which regulatory registries list ZytoVision GmbH’s devices?

Accepted Answer

ZytoVision GmbH’s devices are registered in the eudamed database, which is the official EU registry for medical devices and IVDs. This platform is used to track and verify compliance with EU regulatory requirements, ensuring transparency and traceability of devices authorized for use within the European market.

Question 4

How are ZytoVision GmbH’s devices classified under EU regulations?

Accepted Answer

ZytoVision GmbH’s devices fall under multiple classification categories in the EU: Class A (typically low-risk devices), Class C (moderate-risk devices, often involving surgical implants or significant patient risk), and IVD General (in vitro diagnostic medical devices used for testing human specimens). Classification is determined based on factors like intended use, risk to patients, and the nature of the device, as defined by EU Medical Device Regulations (MDR) and IVDR.

Question 5

What is the primary purpose of ZytoVision GmbH’s software tools, like VisionArray MultiScan?

Accepted Answer

Software tools like VisionArray MultiScan are designed for digital pathology analysis, enabling laboratories to automate and streamline the evaluation of stained tissue samples. These tools assist pathologists in identifying and quantifying diagnostic markers, improving efficiency, reducing human error, and enhancing the accuracy of histological assessments in clinical diagnostics.

ZytoVision GmbH

Catalogue475

ZUC028-500 Ref ZUC028-500

C-3001-400 Ref C-3001-400

Z-2124-200 Ref Z-2124-200

Z-2199-50 Ref Z-2199-50

Wb-0008-500 Ref WB-0008-500

Z-2093-50 Ref Z-2093-50

Z-2189-200 Ref Z-2189-200

Wb-0005-50 Ref WB-0005-50

Z-2215-50 Ref Z-2215-50

Z-2099-20 Ref Z-2099-20

Z-2015-200 Ref Z-2015-200

ZUC025-500 Ref ZUC025-500

Noa-205 Ref NOA-205

Z-2115-200 Ref Z-2115-200

C-3022-40 Ref C-3022-40

ZytoMation BCL6 Dual Color Break Apart FISH Probe Ref Z-2313-5.1ML

Aura Pretreat 3 Ref NOA-115

Z-2078-50 Ref Z-2078-50

Cytology Pepsin Solution Ref ES-0002-16

C-3055-400 Ref C-3055-400

Wb-0010-150 Ref WB-0010-150

ZytoMation MYC Dual Color Break Apart FISH Probe Ref Z-2312-5.1ML

ZytoDot CISH Implementation Kit Ref C-3018-40

Z-2207-50 Ref Z-2207-50

Z-2176-200 Ref Z-2176-200

What ZytoVision GmbH makes

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