Trek Diagnostic Systems Ltd
GB-MF-000016922 · United Kingdom · East Grinstead, West Sussex
Trek Diagnostic Systems Ltd is registered in the European database on medical devices as a manufacturer, with 45 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
Authorised representative in the Union: Thermo Fisher Diagnostics B.V..
Devices declared under this manufacturer
- SENSITITRE AIM
- SENSITITRE ARGPF
- SENSITITRE ARIS HIQ SYSTEM
- SENSITITRE ESB1F
- SENSITITRE EUENC2F
- SENSITITRE EUGN3F
- SENSITITRE EUGNF
- SENSITITRE FRAM2GN
- SENSITITRE GN7F
- SENSITITRE GNID
- SENSITITRE GPID
- SENSITITRE HK3MHKF
Showing 12 of 45 declared devices.
Catalogue references include ARGPF, EUGNF, FRAM2GN, GN7F, GNID, HK3MHKF.
European nomenclature codes declared: W0104080107, W0104080599, W0104080108, W02030199, W02039099, W010403060101.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | TREK DIAGNOSTIC SYSTEMS, LTD. (GB) · FDA 8021914 |
| Devices in EUDAMED | 45 |
| Country of registration | United Kingdom |
Device-level evidence
| Devices with a numeric GTIN | 45 |
|---|---|
| Found in the U.S. device database | 7 |
| Share | 15.6 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | TREK DIAGNOSTIC SYSTEMS LTD. |
What it holds in Canada
| Licences on record | 1 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 1 |
| First licensed | 2013-01-08 |
Licence types: System (1).
Licensed under: SENSITITRE SYSTEM.
North American profile: Both markets. Trek Diagnostic Systems Ltd is registered in both the United States and Canada.