Optos plc
GB-MF-000019460 · United Kingdom · Dunfermline
Optos plc is registered in the European database on medical devices as a manufacturer, with 9 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 9 |
|---|
Most frequent device types declared: P200, P200Dx, P200C, P200DTx, P200MA, P200T.
Among these devices, 7 are declared active, 2 with a measuring function.
Authorised representative in the Union: Emergo Europe B.V..
Devices declared under this manufacturer
- Arm rest
- California
- Daytona
- MonacoPro
- OptosAdvance
- P200, P200Dx
- P200C
- P200MA
- Silverstone
Catalogue references include A10021, A10022, A10600, A10650, A10700, A10750.
European nomenclature codes declared: Z12120114, Z119082,Z12120114, Z119082, Z12011280.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | OPTOS PLC (GB) · FDA 9617167 |
| Devices in EUDAMED | 9 |
| Country of registration | United Kingdom |
Device-level evidence
| Devices with a numeric GTIN | 6 |
|---|---|
| Found in the U.S. device database | 6 |
| Share | 100.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | OPTOS INC. |
North American profile: Both markets. Optos plc is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
HZ 1552432-1 | issued | 2026-09-27 |