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EUDAMED update: May 2, 2024
US-MF-000018369US-MF-000018369SRN
An SRN is the unique EUDAMED identifier assigned to a manufacturer, authorised representative or importer when it registers as an actor.
View in glossary →SRN
An SRN is the unique EUDAMED identifier assigned to a manufacturer, authorised representative or importer when it registers as an actor.
View in glossary →Optovue, Inc. is a medical device manufacturer registered in EUDAMED. The company has 3 devices on the EU market across 32 countries. It holds 1 valid CE certificate. Headquartered in San Jose, United States. Explore the regulatory profile, devices and certificates on MD Atlas.
Devices placed in 32 countries
1 approved member
Showing 1–2 of 2 device families.
8 EU importers place this manufacturer's devices
1 authorised representative routes this manufacturer's devices
Showing 1–3 of 3 devices.
| Product | Trade name | Reference / catalog number | UDI-DI code | Quantity | Status |
|---|---|---|---|---|---|
| iVue 80 | iVue 80 | iVue 100 | 00858848006773 | 1 | On the market |
| Solix | Solix | Solix | 00858848006803 | 1 | On the market |
| Solix Essential | Solix Essential | Solix Essential | 00858848006261 | 1 | On the market |