Tristel Solutions Limited
GB-MF-000010046 · United Kingdom · Snailwell, Cambridgeshire
Tristel Solutions Limited is registered in the European database on medical devices as a manufacturer, with 41 devices declared. It has a similarly named entry in the FDA register that we have not verified.
What this manufacturer declares
| Class IIa | 41 |
|---|
Most frequent device types declared: (2 x (2 x 400ml), 1 x Trigger head), 1 X (2 X 100ml), 1 X 250ml (as a part of TRISTEL VISI Combination Pack), 1 x (2 x 125ml), 1 x (2x400ml).
Among these devices, 2 are declared sterile, 1 active.
Authorised representative in the Union: Tristel NV.
Devices declared under this manufacturer
- FUSE
- JET
- JET LUX (MD and BIO – BE/FR) Recharge pack
- JET LUX (MD and BIO) - EN
- JET LUX (MD and BIO) – BE/FR
- JET LUX (MD) 2 x trigger heads
- JET PRO
- POD CLO2 10+5
- POD CLO2 5
- Tristel DUO OPH
- Tristel DUO WIPES
- Tristel Pre-Clean Wipe
Showing 12 of 41 declared devices.
Catalogue references include CCH010501, CCH010701, CCH011302, CCH080101, Single Unit, TSL022701, TSL023901.
European nomenclature codes declared: D030302, D0801, V9099, Z12011385, D0899, Z12011399.
United States market access
| FDA establishment register | Similar name found — unverified |
|---|---|
| Matched entry | TRISTEL SOLUTION LTD (GB) · FDA 3006892175 |
| Devices in EUDAMED | 41 |
| Country of registration | United Kingdom |
⚠️ A similar name exists; we do not assert it is the same company — why.
Device-level evidence
| Devices with a numeric GTIN | 41 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | TRISTEL SOLUTIONS LTD. |
What it holds in Canada
| Licences on record | 4 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 4 |
| First licensed | 2021-04-22 |
Licence types: System (3), Single Device (1).
Licensed under: TRISTEL DUO OPH, TRISTEL ULT, TRISTEL OPH, TRISTEL ORL.