Summit Medical Ltd
GB-MF-000019193 · United Kingdom · Gloucestershire
Summit Medical Ltd is registered in the European database on medical devices as a manufacturer, with 41 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 41 |
|---|
Among these devices, 32 are declared sterile, 5 reusable, 4 active.
Authorised representative in the Union: MDSS GmbH.
Devices declared under this manufacturer
- 9mm Nozzle with Nozzle Extruder
- Bone Cement Delivery Gun
- HiVac™ 7
- HiVac™ 7 Triple Mix
- HiVac™ Syringe
- Knee Nozzle
- MiniMix™
- MiniMix™ Delivery Syringe
- MiniMix™ LV
- Mixing bowl, Spatula
- Quick-Vac® Vacuum Mixing Bowl
- SmartMix™ Curettes
Showing 12 of 41 declared devices.
Catalogue references include 5401-10-002, 5401-96-500, C703, C901, H759, S727.
European nomenclature codes declared: P099002.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | SUMMIT MEDICAL LTD. (GB) · FDA 9617155 |
| Devices in EUDAMED | 41 |
| Country of registration | United Kingdom |
Device-level evidence
| Devices with a numeric GTIN | 41 |
|---|---|
| Found in the U.S. device database | 27 |
| Share | 65.9 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | SUMMIT MEDICAL LTD. |
What it holds in Canada
| Licences on record | 17 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 17 |
| First licensed | 2004-06-07 |
Licence types: Single Device (7), System (4), Device Group (3), Device Group Family (2).
Licensed under: PRISM II VACUUM MIXING CARTRIDGE, SMARTMIX TOWER VACUUM MIXING CARTRIDGE, CEMENT NOZZLES, SMARTMIX MINI BONE CEMENT MIXING AND DELIVERY , CEMENT MIXING AND DELIVERY SYSTEM, HIVAC SYRINGE.
North American profile: Both markets. Summit Medical Ltd is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
GB2300000400 | amended | 2028-11-27 |