Quantib BV
NL-MF-000027601 · Netherlands · Rotterdam
Quantib BV is registered in the European database on medical devices as a manufacturer, with 12 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIb | 8 |
|---|---|
| Class IIa | 4 |
Most frequent device types declared: 2.5, QPR.
Among these devices, 12 are declared active, 8 with a measuring function.
No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 12 |
| Country of registration | Netherlands |
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
SCAR-13.2.2.1 | amended | 2030-08-01 |