OrbusNeich Medical, B.V.
NL-MF-000010907 · Netherlands · Hoevelaken
OrbusNeich Medical, B.V. is registered in the European database on medical devices as a manufacturer, with 511 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class I | 329 |
|---|---|
| Class IIa | 182 |
Most frequent device types declared: Ø 4.0 x 20 mm, Ø 3.0 x 20 mm, Ø 2.5 x 20 mm, Ø 3.5 x 20 mm, Ø 2.0 x 20 mm.
Among these devices, 510 are declared sterile, 38 implantable.
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 | 511 |
| 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.