Optikon 2000 S.p.A.
IT-MF-000017618 · Italy · Roma
Optikon 2000 S.p.A. is registered in the European database on medical devices as a manufacturer, with 182 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 114 |
|---|---|
| Class IIb | 68 |
Most frequent device types declared: 116001, 181007, Phaco Tips Wrench.
Among these devices, 140 are declared sterile, 75 active.
Devices declared under this manufacturer
- 20G flared bent phaco tip, 30°
- 20G flared phaco tip, 30°
- 22G PHACO TIP, 30°
- 23G VITRECTOMY KIT ST 2W FES
- 25G VITRECTOMY KIT SC 2W FES
- AGILE Infusion Set
- ASSISTANT / PULSAR 2 ESP COVERS
- Injection/removal silicone oil kit with 20G/23G/25G cannulas
- KIT PHACO FULL 20/FLB 2ST
- KIT PHACO FULL 21/FL 2STW
- KIT PHACO FULL 21/FLB 2ST
- KIT PHACO FULL 22/FLB ST
Showing 12 of 182 declared devices.
Catalogue references include 113107, 113209, 191337, 192703A, 193533, 19500Z.
European nomenclature codes declared: Q021113, Q020699, A070102, Q020680, T030199, L1713.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 182 |
| Country of registration | Italy |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 182 |
|---|---|
| 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. Optikon 2000 S.p.A. was not found in either the U.S. or the Canadian register.