Xiros Limited
GB-MF-000004396 · United Kingdom · Leeds
Xiros Limited is registered in the European database on medical devices as a manufacturer, with 42 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 18 |
|---|---|
| Class IIb | 24 |
Most frequent device types declared: 102-1040, 102-1080, 102-1082, 102-1083, 102-1090XI.
Among these devices, 42 are declared sterile, 24 implantable.
Authorised representative in the Union: Advena Limited.
Devices declared under this manufacturer
- CC-Hook Left
- CC-Hook Right
- FlexPasser Tendon Retrieval Kit
- Infinity-Lock 5
- Infinity-Lock Button System
- JewelACL
- Malleable Probe
- Pitch-Patch Tissue Reinforcement Device 30 x 20mm
- Pitch-Patch Tissue Reinforcement Device 35 x 25mm
- Poly-Tape (TUBE) (dia. 5) x 500mm
- Poly-Tape 10 x 800mm
- Poly-Tape 20 x 800mm
Showing 12 of 42 declared devices.
Catalogue references include 102-1040, 102-1083, 102-1090XI, 102-1098, 102-6003, 202-1411.
European nomenclature codes declared: P0999, P091399, V901699.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | XIROS LTD (GB) · FDA 8044102 |
| Devices in EUDAMED | 42 |
| Country of registration | United Kingdom |
Device-level evidence
| Devices with a numeric GTIN | 42 |
|---|---|
| Found in the U.S. device database | 6 |
| Share | 14.3 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | XIROS LIMITED |
What it holds in Canada
| Licences on record | 7 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 3 |
| Class 3 devices | 4 |
| First licensed | 2022-07-13 |
Licence types: Device Family (4), Single Device (2), System (1).
Licensed under: INFINITY-LOCK BUTTON SYSTEM, CC-HOOK, SEKURE-LOOP, PITCH-PATCH, POLY-TAPE/INFINITY-LOCK, FLEXPASSER TENDON RETRIEVAL KIT.
North American profile: Both markets. Xiros Limited is registered in both the United States and Canada.