Plusoptix GmbH
DE-MF-000006138 · Germany · Nürnberg
Plusoptix GmbH is registered in the European database on medical devices as a manufacturer, with 8 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 8 |
|---|
Most frequent device types declared: A12C, A12R, S12C, S12R, S16, A16, S20, A20.
Among these devices, 8 are declared active, 8 with a measuring function.
Devices declared under this manufacturer
- plusoptiX A12C
- plusoptiX A12R
- plusoptiX A16
- plusoptiX A20
- plusoptiX S12C
- plusoptiX S12R
- plusoptiX S16
- plusoptiX S20 Vision Screener
Catalogue references include A12C, A12R, A16, A20, S12C, S12R.
European nomenclature codes declared: Q0299.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | PLUSOPTIX GMBH (DE) · FDA 3003829667 |
| Devices in EUDAMED | 8 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 8 |
|---|---|
| Found in the U.S. device database | 6 |
| Share | 75.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | PLUSOPTIX GMBH |
What it holds in Canada
| Licences on record | 2 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 2 |
| First licensed | 2013-12-06 |
Licence types: Device Family (2).
Licensed under: PLUSOPTIX 12, PLUSOPTIX 20.
North American profile: Both markets. Plusoptix GmbH is registered in both the United States and Canada.