Cook Ireland Limited
IE-MF-000001530 · Ireland · Limerick
Cook Ireland Limited is registered in the European database on medical devices as a manufacturer, with 6 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 6 |
|---|
Among these devices, 6 are declared sterile.
Devices declared under this manufacturer
- EchoTip AcuCore
- EchoTip ClearCore
Catalogue references include CT9.5-90-FM-I, ECHO-BX-19, ECHO-BX-22, ECHO-BX-3-22, ECHO-PPG-25-I, ZDO-22-30.
European nomenclature codes declared: A01020102, G030899, G0199.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | COOK IRELAND LTD (IE) · FDA 3001845648 |
| Devices in EUDAMED | 6 |
| Country of registration | Ireland |
Device-level evidence
| Devices with a numeric GTIN | 6 |
|---|---|
| Found in the U.S. device database | 3 |
| Share | 50.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | COOK IRELAND LTD. |
What it holds in Canada
| Licences on record | 32 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 15 |
| Class 3 devices | 14 |
| Class 4 devices | 3 |
| First licensed | 2001-05-04 |
Licence types: Device Group Family (19), Device Family (7), Device Group (4), Single Device (2).
Licensed under: DISPOSABLE BIOPSY FORCEPS, URETERAL STENT SETS, PANCREATIC PSEUDOCYST ACCESS DEVICE, PANCREATIC STENT SET, ECHOTIP ULTRA CELIAC PLEXUS NEUROLYSIS NEEDLE, DUETTE KIT.
North American profile: Both markets. Cook Ireland Limited is registered in both the United States and Canada.