Aiforia Technologies Plc
Finland FI-MF-000008986 Last updated 21 Oct 2026
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- Devices
- 14
- Registries
- EUDAMED
- FDA recalls
- 0
Catalogue
Aiforia® Prostate Cancer Cribriform Ref Aiforia® Prostate Cancer Cribriform
Aiforia® Clinical AI Model for Lung Cancer; PD-L1 Ref Aiforia® Clinical AI Model for Lung Cancer; PD-L1
Aiforia® Clinical AI Model for Breast Cancer; Ki67 Ref Aiforia® Clinical AI Model for Breast Cancer; Ki67
Aiforia® Breast Cancer Grading Ref Aiforia® Breast Cancer Grading
Aiforia® Prostate Cancer Biopsy Ref Aiforia® Prostate Cancer Biopsy
Aiforia® Clinical AI Model for Prostate Cancer; Gleason Grade Groups Ref Aiforia® Clinical AI Model for Prostate Cancer; Gleason Grade Groups
Aiforia® Clinical AI Model for Breast Cancer; PR Ref Aiforia® Clinical AI Model for Breast Cancer; PR
Aiforia® Prostate Cancer G4 Cribriform Ref Aiforia® Prostate Cancer G4 Cribriform
Aiforia® Clinical AI Model for Breast Cancer - HER2 Ref Aiforia® Clinical AI Model for Breast Cancer - HER2
Aiforia® Clinical AI Model for Breast Cancer; ER Ref Aiforia® Clinical AI Model for Breast Cancer; ER
Aiforia® Prostate Cancer PNI Ref Aiforia® Prostate Cancer PNI
Aiforia® Clinical Suite Viewer Ref Aiforia® Clinical Suite Viewer
Aiforia® Gastric Cancer Ref Aiforia® Gastric Cancer
Aiforia® Lymph Node Metastasis Ref Aiforia® Lymph Node Metastasis
EUDAMED certificates
Notified body 2797 1 certificate
- IVDR 798482 Issued
Quality management system EU IVDR
- Issued
- 18 Feb 2025
- Expires
- 17 Feb 2030
Related companies
Notified bodies
- Notified body 2797
About
Aiforia provides software and services for pathologists, scientists and healthcare professionals to use artificial intelligence for image analysis.
What Aiforia Technologies Plc makes
The company develops AI-powered clinical models for digital pathology, including automated analysis tools for lung cancer (PD-L1), breast cancer (Ki67, HER2, PR, ER), and prostate cancer (Gleason grading, biopsy assessment, and specific histological patterns like cribriform structures and perineural invasion). It also offers software suites for viewing and managing pathology image data, designed to assist in diagnostic workflows.
These products fall under Class C medical devices and in vitro diagnostic (IVD) general categories, with listings maintained in the EU’s eudamed registry. The company is based in Finland.
Frequently asked questions
What types of medical devices does Aiforia Technologies Plc manufacture?
Aiforia Technologies Plc specializes in AI-powered software solutions for digital pathology. Its devices include automated clinical AI models for analyzing pathology images, such as those used for diagnosing lung cancer (PD-L1), breast cancer (Ki67, HER2, PR, ER), and prostate cancer (Gleason grading, biopsy assessment, and specific patterns like cribriform structures and perineural invasion). The company also provides software suites for viewing and managing pathology image data, supporting diagnostic workflows.
Where is Aiforia Technologies Plc based?
Aiforia Technologies Plc is based in Finland. The company’s headquarters and operations are located within the country, aligning with its focus on developing AI-driven pathology tools for global healthcare professionals.
Which regulatory registries list Aiforia Technologies Plc’s devices?
Aiforia Technologies Plc’s devices are listed in the EU’s eudamed registry. This platform is the official database for medical device information within the European Union, ensuring transparency and traceability of authorized products under its regulatory framework.
How are Aiforia Technologies Plc’s devices classified under medical device regulations?
Aiforia Technologies Plc’s devices fall under Class C medical device classifications and in vitro diagnostic (IVD) general categories. This classification is determined by factors like the intended use, risk level, and potential impact on patient health, guiding regulatory oversight and compliance requirements.
Information
- Country
- Finland
- Address
- 29-31 D, Pursimiehenkatu , Helsinki, Finland
- Website
- www.aiforia.com/
- facebook.com/aiforiatech
- [email protected]
- PRRC contact
- Mikael Lundin
- EUDAMED SRN
- FI-MF-000008986