Integra LifeSciences (Ireland) Limited
IE-MF-000003849 · Ireland · Tullamore, Co. Offaly
Integra LifeSciences (Ireland) Limited is registered in the European database on medical devices as a manufacturer, with 39 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 34 |
|---|---|
| Class IIb | 5 |
Among these devices, 3 are declared sterile.
Devices declared under this manufacturer
- CUSA® Clarity
- CUSA® Excel
- Camino®
- Integra®
- Licox®
Showing 12 of 39 declared devices.
Catalogue references include BC10PV, BC10R, BC10TV, C7036RR, ICP-17, ICP-39.
European nomenclature codes declared: L99, Z12010885, Z12010880, V9099.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | INTEGRA LIFESCIENCES (IRELAND) LIMITED (IE) · FDA 3006697299 |
| Devices in EUDAMED | 39 |
| Country of registration | Ireland |
Device-level evidence
| Devices with a numeric GTIN | 39 |
|---|---|
| Found in the U.S. device database | 39 |
| Share | 100.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | INTEGRA LIFESCIENCES (IRELAND) LIMITED |
What it holds in Canada
| Licences on record | 13 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 10 |
| Class 3 devices | 1 |
| Class 4 devices | 2 |
| First licensed | 1998-12-18 |
Licence types: Single Device (8), System (2), Device Family (2), Device Group Family (1).
Licensed under: CUSA EXCEL/CUSA EXCEL+ SYSTEM, CUSA EXTENDED MICRO TIP PLUS, CUSA SABER TIP, CUSA SHEARTIP, TEST DEVICES FOR LICOX BRAIN MONITORING SYSTEM, CABLES FOR LICOX BRAIN MONITORING SYSTEM.
North American profile: Both markets. Integra LifeSciences (Ireland) Limited is registered in both the United States and Canada.