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: 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, Opthalmic Viscosurgical Device.
Among these devices, 33 are declared sterile, 21 implantable.
Devices declared under this manufacturer
- Algyl Coll
- Artro DC 2.2%
- GenPlus 3.0%
- Ortholand Cross 2.5%
- VisOcu
- ViscOge
- ViscoPhi %2.2
- ViscoPhi 1.5%
- ViscoPhi 1.6%
- ViscoPhi 2.0%
- ViscoPhi 2.5%
- ViscoPhi Cross 2.0%
Showing 12 of 33 declared devices.
Catalogue references include PHI202DE-VSPT, PHI203DE-VSP, PHI203DE-VSPC, PHI222DE-ART, PHI2548DE-VSP, PHI254DE-VSPC.
European nomenclature codes declared: P900402, Q02030301.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 33 |
| Country of registration | Germany |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 33 |
|---|---|
| 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. Phibio GmbH was not found in either the U.S. or the Canadian register.
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1TD-MDR-0076/10/2025 | withdrawn | 2028-10-01 |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 |