Cellbytes Ltd
Finland FI-MF-000050442 Last updated 21 Oct 2026
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- Devices
- 1
- Registries
- EUDAMED
- FDA recalls
- 0
Catalogue
Cellbytes Ref CB
About
Cellbytes is a digital hematology system designed to augment hematopathologists, not replace them. Standardized, real-time digital assessment can enhance human performance and decrease subjectivity. Trained on millions of cells across diverse hematologic conditions, Cellbytes provides consistent, high-quality outputs. Every model prediction comes with clear visualizations and quantifiable data, ensuring transparency and supporting users to review what the software has identified.
What Cellbytes Ltd makes
Cellbytes Ltd produces a digital hematology system called Cellbytes, which analyzes and assesses hematologic conditions using standardized, real-time imaging and AI-driven analysis. The system generates consistent, quantifiable outputs and visualizations to support hematopathologists in their evaluations, reducing subjectivity in diagnostic workflows.
The Cellbytes system is classified as a Class A medical device and is registered in the EU’s eudamed database. The company is based in Finland.
Frequently asked questions
What types of medical devices does Cellbytes Ltd manufacture?
Cellbytes Ltd specializes in digital hematology systems. Their primary product, called Cellbytes, is designed to assist hematopathologists by providing standardized, real-time digital assessments of hematologic conditions. The system uses AI-driven analysis to generate consistent, quantifiable outputs and visualizations, helping to reduce subjectivity in diagnostic workflows.
Where is Cellbytes Ltd based?
Cellbytes Ltd is based in Finland. The company’s headquarters and operations are located within the country, which aligns with its regulatory obligations and market focus.
Which regulatory registries list Cellbytes Ltd’s devices?
Cellbytes Ltd’s devices are listed in the EU’s eudamed database. This registry is part of the European Union’s medical device regulatory framework, ensuring transparency and traceability of devices authorized for use within the EU market.
How are Cellbytes Ltd’s devices classified under medical device regulations?
Cellbytes Ltd’s devices are classified as Class A medical devices. This classification is determined based on the risk associated with the device, with Class A representing the lowest risk category. The classification influences the regulatory requirements and oversight needed for market authorization.
Information
- Country
- Finland
- Address
- 8, Tukholmankatu, HUS, Finland
- Website
- www.cellbytes.io
- linkedin.com/company/cellbytes
- [email protected]
- PRRC contact
- Mikko Purhonen
- EUDAMED SRN
- FI-MF-000050442