ZytoVision GmbH
Germany DE-MF-000024390 Last updated 23 Oct 2026
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- Devices
- 475
- Registries
- EUDAMEDFDA
- FDA recalls
- 0
Catalogue
Rabbit anti-Helicobacter pylori [polyclonal] Ref RBK012
Rabbit anti-Helicobacter pylori [polyclonal] Ref RBK012-05
Z-2168-200 Ref Z-2168-200
VisionArray MultiScan Software Ref E-4302
Nuclear Blue Solution Ref CS-0002-20
T-1114-400 Ref T-1114-400
Z-2175-50 Ref Z-2175-50
Aura Pretreat 2 Ref NOA-104
ZUC029-500 Ref ZUC029-500
HRP/AP-Polymer-Mix Ref AB-0013-1
Z-2108-50 Ref Z-2108-50
Z-2114-50 Ref Z-2114-50
Aura Dewax 1 Ref NOA-101
Aura Wash 1 Ref NOA-602
Z-2109-50 Ref Z-2109-50
C-3064-100 Ref C-3064-100
Formaldehyde Dilution Buffer Set Ref PT-0006-100
AP-Red Solution B Ref SB-0006b-4
Z-2274-50 Ref Z-2274-50
ZUC052-500 Ref ZUC052-500
ZytoLight SPEC SS18/SSX1 TriCheck Probe Ref Z-2184-50
ZUC007-006 Ref ZUC007-006
HRP/AP-Polymer-Mix Ref AB-0013-16
Z-2074-200 Ref Z-2074-200
Z-2167-200 Ref Z-2167-200
Z-2082-200 Ref Z-2082-200
Z-2162-50 Ref Z-2162-50
ZytoLight Aneuploidy Panel X/Y and 13/18/21 Ref Z-2104-20
HRP-Green Solution A Ref SB-0007a-0.2
Z-2018-50 Ref Z-2018-50
C-3063-400 Ref C-3063-400
ZUC029-100 Ref ZUC029-100
ZUC008-500 Ref ZUC008-500
AP-Red Solution A Ref SB-0006a-0.1
Z-2286-50 Ref Z-2286-50
ZytoLight SPEC PML/RARA Dual Color Dual Fusion Probe Ref Z-2113-50
DAPI/DuraTect-Solution Ref MT-0007-0.2
Z-2285-50 Ref Z-2285-50
ZytoLight SPEC Angelman Dual Color Probe Ref Z-2319-50
Z-2096-200 Ref Z-2096-200
T-1063-40 Ref T-1063-40
Z-2193-50 Ref Z-2193-50
ZytoLight SPEC 18/CEN X/Y Triple Color Probe Ref Z-2163-200
ZUC007-125 Ref ZUC007-125
ZUC050-100 Ref ZUC050-100
ZUC037-008 Ref ZUC037-008
ZytoDot 2C SPEC ERBB2/CEN 17 Probe Ref C-3032-100
Z-2269-200 Ref Z-2269-200
Aura Dewax 2 Ref NOA-102
ZytoLight SPEC ETV6/RUNX1 Dual Color Dual Fusion Probe Ref Z-2157-50
Showing 1-50 of 475
What ZytoVision GmbH makes
ZytoVision GmbH produces immunohistochemical reagents, including polyclonal antibodies such as Rabbit anti-Helicobacter pylori, and automated tissue processing solutions like the Aura Pretreat 2 and Aura Dewax 1. Their portfolio also includes software tools like VisionArray MultiScan for digital pathology analysis and various staining kits for diagnostic use in histology labs.
The company’s devices are classified under EU regulations as Class A, Class C, and In Vitro Diagnostic Medical Devices (IVD General), with relevant products registered in the EU’s eudamed database. ZytoVision GmbH is based in Germany and adheres to EU regulatory requirements for medical device compliance.
Frequently asked questions
What types of medical devices does ZytoVision GmbH manufacture?
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.
Where is ZytoVision GmbH based, and what regulatory framework does it follow?
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.
Which regulatory registries list ZytoVision GmbH’s devices?
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.
How are ZytoVision GmbH’s devices classified under EU regulations?
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.
What is the primary purpose of ZytoVision GmbH’s software tools, like VisionArray MultiScan?
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.
Information
- Country
- Germany
- Address
- 1, Fischkai, Bremerhaven, Germany
- Website
- www.zytovision.com/
- [email protected]
- Phone
- +49 (0)471 4832300
- PRRC contact
- Carl Christian Cordshagen
- EUDAMED SRN
- DE-MF-000024390
- FDA FEI number
- 3005704042