MAK-SYSTEM Group Ltd.
GB-MF-000026178 · United Kingdom · London
MAK-SYSTEM Group Ltd. is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
Most frequent device types declared: v1.1, v10.5, v11.0, v2.0, v5.0.3.
Authorised representative in the Union: AR Experts B.V..
Devices declared under this manufacturer
- COSMAS
- T.C.S.
- ePROGESA
- eTraceLine
Catalogue references include COSMAS, T.C.S., ePROGESA, eTraceLine, eTraceLine (eTL).
European nomenclature codes declared: W02079092.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | MAK-SYSTEM Group Ltd. (GB) · FDA 9613847 |
| Devices in EUDAMED | 5 |
| Country of registration | United Kingdom |
Device-level evidence
| Devices with a numeric GTIN | 5 |
|---|---|
| Found in the U.S. device database | 2 |
| Share | 40.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: United States only. MAK-SYSTEM Group Ltd. is registered in the United States but was not found in the Canadian register.