ClearStream Technologies Ltd
IE-MF-000011725 · Ireland · Enniscorthy, County Wexford
ClearStream Technologies Ltd is registered in the European database on medical devices as a manufacturer, with 226 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 226 |
|---|
Among these devices, 226 are declared sterile.
Devices declared under this manufacturer
- BANTAM
- LITEPAC
Showing 12 of 226 declared devices.
Catalogue references include 48010025, 48506020, 48522030, 48528020, 48528050, 68202099.
European nomenclature codes declared: C010402020101.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | CLEARSTREAM TECHNOLOGIES LTD. (IE) · FDA 9616666 |
| Devices in EUDAMED | 226 |
| Country of registration | Ireland |
Device-level evidence
| Devices with a numeric GTIN | 226 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | CLEARSTREAM TECHNOLOGIES, LTD. |
What it holds in Canada
| Licences on record | 5 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 2 |
| Class 3 devices | 2 |
| Class 4 devices | 1 |
| First licensed | 2017-08-31 |
Licence types: Device Family (2), Single Device (1), Device Group Family (1), System (1).
Licensed under: LIFESTREAM BALLOON EXPANDABLE VASCULAR COVERED, WAVELINQ ENDOAVF SYSTEM, TVA MEDICAL ELECTROSURGICAL GENERATOR ESU-1, HALO ONE THIN-WALLED GUIDING SHEATH, WAVELINQ GENERATOR.
North American profile: Both markets. ClearStream Technologies Ltd is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
2249575CE04 | issued | 2027-01-01 |
2249575CE03 | supplemented | 2027-01-01 |
2249575CE01 | issued | 2027-01-01 |