ORTEC B.V.
NL-MF-000036789 · Netherlands · Zoetermeer
ORTEC B.V. is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 5 |
|---|
Among these devices, 5 are declared active.
Catalogue references include Acute Care Triage, Stroke Triage App, U-Prevent.
European nomenclature codes declared: V92, Z129092.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 5 |
| 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 | 5 |
|---|---|
| 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: Neither register. ORTEC B.V. was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
P000535115CRT01 | issued | 2031-06-15 |