Insight Medical Products Ltd
GB-MF-000004395 · United Kingdom · Gloucestershire
Insight Medical Products Ltd is registered in the European database on medical devices as a manufacturer, with 35 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 35 |
|---|
Most frequent device types declared: Non Sterile Bite Guard.
Authorised representative in the Union: Advena Limited.
Devices declared under this manufacturer
- Non Sterile Eye Shield -White (Left Eye)
- Non Sterile Eye Shield -White (Right Eye)
- Purifoam Laryngectomy Filters
- Silicone Fixation Tape 4cm x 1.5m
- Tracheostomy Speaking Valve (Blue)
- Tracheostomy Speaking Valve (White)
- Tracheostomy Tube Cleaning Swab Extra Long
- Transducer Holder
- TraxGuard Tracheostomy and Laryngectomy Protector. Large Black
- TraxGuard Tracheostomy and Laryngectomy Protector. Large White
- TraxGuard Tracheostomy and Laryngectomy Protector. Small Grey
- TraxGuard Tracheostomy and Laryngectomy Shower Protector
Showing 12 of 35 declared devices.
Catalogue references include ES/500/WL, ES/500/WR, TB/303, TCS/1000, TFP/400, TH/100.
European nomenclature codes declared: R01058002, M040306, R01058099, R01038099, Y093399, R90060202.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 35 |
| Country of registration | United Kingdom |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 35 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
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: Neither register. Insight Medical Products Ltd was not found in either the U.S. or the Canadian register.