CYTOGNOS, S.L
ES-MF-000000318 · Spain · Santa Marta de Tormes
CYTOGNOS, S.L is registered in the European database on medical devices as a manufacturer, with 42 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
Most frequent device types declared: CYT-16PE7+56PE, CYT-8F8, CYT-INF-BASIC, CYT-KAPPF2, CYT-KAPPPE.
Devices declared under this manufacturer
- B-cell precursor Acute Lymphoblastic Leukemia Minimal Residual Disease
- Bulklysis™
- CD10-APC-C750
- CD16-PE+CD56-PE
- CD45-APC-C750
- CD8-FITC
- Infinicyt Basic CE-IVD
- KAPPA-PE
- Kappa-FITC
- Kappa-FITC/Lambda-PE
- LAMBDA-APC-C750
- Lambda-FITC/Kappa-PE
Showing 12 of 42 declared devices.
Catalogue references include CYT-16PE7+56PE, CYT-8F8, CYT-KAPPF2, CYT-KAPPPE, CYT-KF2-LPE-100, CYT-LF-KPE-100.
European nomenclature codes declared: W0103080699, W0103080599, W0202040182.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | CYTOGNOS, S.L. (ES) · FDA 3009869675 |
| Devices in EUDAMED | 42 |
| Country of registration | Spain |
Device-level evidence
| Devices with a numeric GTIN | 42 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
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: United States only. CYTOGNOS, S.L is registered in the United States but was not found in the Canadian register.