Tcoag ireland ltd
IE-MF-000027371 · Ireland · Co. Wicklow
Tcoag ireland ltd is registered in the European database on medical devices as a manufacturer, with 64 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
Most frequent device types declared: Destiny Max, Ristocetin (7.5 mg/vial), TriniCLOT Imidazole Buffer, TriniCLOT Lupus Confirm, TriniCLOT PT Excel S 20 mL.
Devices declared under this manufacturer
- Destiny Max
- Ristocetin (7.5 mg/vial)
- TriniCLOT Factor IX
- TriniCLOT Factor VIII
- TriniCLOT Factor X
- TriniCLOT Imidazole Buffer
- TriniCLOT Lupus Confirm
- TriniCLOT PT Excel S 20 mL
- TriniCLOT aPTT S 5 mL
- sthemA 601 (Quark) and Autoloader
- sthemA CL-15
- sthemA DL-9000
Showing 12 of 64 declared devices.
Catalogue references include 01405, 01413, 01423, 50705, M01000, T1103.
European nomenclature codes declared: W0103020702, W0103010105, W0103020102, W0299, W0103020903, W0103020701.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | TCOAG IRELAND LIMITED (IE) · FDA 3008386529 |
| Devices in EUDAMED | 64 |
| Country of registration | Ireland |
Device-level evidence
| Devices with a numeric GTIN | 64 |
|---|---|
| Found in the U.S. device database | 43 |
| Share | 67.2 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | TCOAG IRELAND LIMITED |
What it holds in Canada
| Licences on record | 3 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 1 |
| Class 3 devices | 2 |
| First licensed | 1999-10-19 |
Licence types: Device Family (1), Test Kit (1), System (1).
Licensed under: PLATELIN REAGENTS, BIOPOOL RISTOCETIN COFACTOR ASSAY, KC4 DELTA COAGULATION ANALYZER.
North American profile: Both markets. Tcoag ireland ltd is registered in both the United States and Canada.