EU → North America Device Access

ZytoVision GmbH

DE-MF-000024390 · Germany · Bremerhaven

ZytoVision GmbH is registered in the European database on medical devices as a manufacturer, with 486 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Most frequent device types declared: ZytoChem Plus biotinylated secondary antibody, broad spectrum, ZytoDot 2C SPEC IGH Break Apart Probe, ZytoDot 2C SPEC ROS1 Break Apart Probe, ZytoLight SPEC ALK/EML4 TriCheck Probe, ZytoLight SPEC BCL2/IGH Dual Color Dual Fusion Probe.

Devices declared under this manufacturer

Showing 12 of 486 declared devices.

Catalogue references include C-3063-100, Z-2114-200, Z-2140-200, Z-2160-50, Z-2197-50, Z-2306-5.1ML.

European nomenclature codes declared: W01030703, W01030799, W0580, W01030709, W02079082.

United States market access

FDA establishment registerRegistered with FDA
Matched entryZYTOVISION GMBH (DE) · FDA 3005704042
Devices in EUDAMED486
Country of registrationGermany

Device-level evidence

Devices with a numeric GTIN486
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryZYTOVISION GMBH

What it holds in Canada

Licences on record18
Currently active0
Class 2 devices18
First licensed2026-03-18

Licence types: Device Family (17), Single Device (1).

Licensed under: ZYTOLIGHT FISH-TISSUE IMPLEMENTATION KIT, ZYTOLIGHT SPEC MAML2 DUAL COLOR BREAK APART PR, ZYTOLIGHT SPEC ALK DUAL COLOR BREAK APART PROB, ZYTOLIGHT SPEC NTRK2 DUAL COLOR BREAK APART PR, ZYTOLIGHT SPEC BCL2 DUAL COLOR BREAK APART PRO, ZYTOLIGHT SPEC NTRK1 DUAL COLOR BREAK APART PR.

North American profile: Both markets. ZytoVision GmbH is registered in both the United States and Canada.

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