MatOrtho Limited
GB-MF-000007614 · United Kingdom · Leatherhead
MatOrtho Limited is registered in the European database on medical devices as a manufacturer, with 313 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class I | 305 |
|---|---|
| Class IIb | 8 |
Most frequent device types declared: Medial Rotation Knee, PIPR, ReCerf™ Ceramic Resurfacing Head, SAIPH.
Among these devices, 313 are declared sterile, 313 implantable.
Authorised representative in the Union: MatOrtho Ireland Limited.
Devices declared under this manufacturer
- ADEPT
- Medial Rotation Knee
- PIPR
- ReCerf™
- ReCerf™ Ceramic Resurfacing Cup
- ReCerf™ Ceramic Resurfacing Head
- SAIPH
Showing 12 of 313 declared devices.
Catalogue references include 156-383, 181-150, 181-152, 181-154, 190-112, 193-026.
European nomenclature codes declared: P090903020202, P0909030101, P090903020301, P09080302, P09080402, P090903020104.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | MatOrtho Limited (GB) · FDA 3016096064 |
| Devices in EUDAMED | 313 |
| Country of registration | United Kingdom |
Device-level evidence
| Devices with a numeric GTIN | 313 |
|---|---|
| Found in the U.S. device database | 194 |
| Share | 62.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | MATORTHO LIMITED |
What it holds in Canada
| Licences on record | 1 |
|---|---|
| Currently active | 0 |
| Class 3 devices | 1 |
| First licensed | 2026-07-28 |
Licence types: System (1).
Licensed under: RECERF HIP RESURFACING SYSTEM.
North American profile: Both markets. MatOrtho Limited is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
1434-MDR-013/2025 | issued | 2030-06-24 |
1434-MDR-012/2025 | issued | 2030-06-24 |
1434-MDR-010/2025 | issued | 2030-06-24 |
1434-MDR-009/2025 | issued | 2030-06-24 |