Surgical Innovations Ltd.
GB-MF-000012187 · United Kingdom · Leeds
Surgical Innovations Ltd. is registered in the European database on medical devices as a manufacturer, with 294 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIb | 100 |
|---|---|
| Class IIa | 194 |
Most frequent device types declared: 101-47027, 101-49035, EA05XL, ECO-102, YA05VSS03.
Among these devices, 57 are declared sterile, 221 reusable, 99 active.
Authorised representative in the Union: CS Life Sciences Europe Ltd.
Devices declared under this manufacturer
- 235mm Babcock
- 355mm Extra Long Fenestrated Grasper
- 3x55 Pencil Point Trocar
- 3x75 Cannula
- 5mm Seal
- 5mm Single Use Duckbill Valve QTY 3
- 5x450mm Metz Scissor
- 5x55 Cannula + Stopcock
- 5x55 Cannula +Angle +Stopcock
- 5x55 Quill Tip Trocar
- 5x95 Pyramidal Trocar
- 5x95 Quill Tip Trocar
Showing 12 of 294 declared devices.
Catalogue references include 101-47027, 101-49035, EA05XL, ECO-102, YC0307500, YC0505502.
European nomenclature codes declared: L1207, L031299, L1899, L180802, K01020110, K0201010402.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | SURGICAL INNOVATIONS LTD (GB) · FDA 9680952 |
| Devices in EUDAMED | 294 |
| Country of registration | United Kingdom |
Device-level evidence
| Devices with a numeric GTIN | 294 |
|---|---|
| Found in the U.S. device database | 280 |
| Share | 95.2 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | SURGICAL INNOVATIONS LIMITED |
What it holds in Canada
| Licences on record | 6 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 6 |
| First licensed | 2011-11-02 |
Licence types: System (3), Device Family (1), Single Device (1), Device Group Family (1).
Licensed under: ENDOFLEX PRETZEL RETRACTOR, LOGI RANGE, LOGIFLEX - LAPAROSCOPIC INSTRUMENT SYSTEM, YELLOPORT PLUS CANNULA, YELLOPORT PLUS RESPOSABLE LAPAROSCOPIC PORT AC, YELLOPORT ELITE LAPAROSCOPIC PORT ACCESS SYSTE.
North American profile: Both markets. Surgical Innovations Ltd. is registered in both the United States and Canada.