Phibio GmbH
DE-MF-000045435 · Germany · Frankfurt am Main
Phibio GmbH is registered in the European database on medical devices as a manufacturer, with 33 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class I | 21 |
|---|---|
| Class IIb | 12 |
Most frequent device types declared: Opthalmic Viscosurgical Device, 0.5ml - 1.0ml - 1.5ml - 2.0ml - 2.5ml - 3.0ml - 4.0ml - 5.0ml, 0.5ml - 1ml - 1.5ml - 2ml - 2.5ml - 3ml - 4ml - 5ml.
Among these devices, 33 are declared sterile, 21 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 | 33 |
| Country of registration | Germany |
⚠️ 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 |
|---|---|---|
6QMS-MDR-0076/06/2025 | issued | 2030-06-11 |
2QMS-MDR-0076/10/2025 | issued | 2028-10-01 |
1TD-MDR-0076/10/2025 | withdrawn | 2028-10-01 |
1TD-MDR-0076/10/2025 | issued | 2028-10-01 |