Agendia N.V
NL-MF-000011684 · Netherlands · Amsterdam
Agendia N.V is registered in the European database on medical devices as a manufacturer, with 8 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
Most frequent device types declared: Agendia DUS FFPE W/Slides, Agendia ES FFPE W/Slides, Agendia NL FFPE W/Slides, Agendia ROW FFPE W/Slides.
Devices declared under this manufacturer
- BluePrint FFPE microarray
- MammaPrint BluePrint Breast Cancer Recurrence and Molecular Subtyping
- MammaPrint FFPE microarray
- Specimen Collection Kit
Catalogue references include 931280, DNS109.01, DUS108.01, ESM107.01, NA (Centralized Lab Product), NLT105.01.
European nomenclature codes declared: W05020102, W05039099.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 8 |
| Country of registration | Netherlands |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 8 |
|---|---|
| Found in the U.S. device database | 1 |
| Share | 12.5 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: Neither register. Agendia N.V was not found in either the U.S. or the Canadian register.