Creagh Medical Ltd
IE-MF-000005164 · Ireland · Ballinasloe, County Galway
Creagh Medical Ltd is registered in the European database on medical devices as a manufacturer, with 72 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 72 |
|---|
Most frequent device types declared: SER18-135-50-220, SER18-135-60-150, SER18-135-70-120, SER18-135-70-220, SER18-135-70-80.
Among these devices, 72 are declared sterile.
Devices declared under this manufacturer
- Advance Serenity 018
- Advance Serenity™ 18
Showing 12 of 72 declared devices.
Catalogue references include SER18-135-50-220, SER18-135-70-120, SER18-135-70-80, SER18-90-10-60, SER18-90-50-150, SER18-90-50-40.
European nomenclature codes declared: C010402020101.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | Creagh Medical Ltd. (IE) · FDA 3005994106 |
| Devices in EUDAMED | 72 |
| Country of registration | Ireland |
Device-level evidence
| Devices with a numeric GTIN | 72 |
|---|---|
| Found in the U.S. device database | 72 |
| Share | 100.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | CREAGH MEDICAL LIMITED |
What it holds in Canada
| Licences on record | 1 |
|---|---|
| Currently active | 0 |
| Class 4 devices | 1 |
| First licensed | 2022-12-20 |
Licence types: Device Family (1).
Licensed under: ADVANCE SERENITY HYDROPHILIC PTA BALLOON CATHE.
North American profile: Both markets. Creagh Medical Ltd is registered in both the United States and Canada.