Astek Innovations Ltd
GB-MF-000013346 · United Kingdom · Altrincham
Astek Innovations Ltd is registered in the European database on medical devices as a manufacturer, with 33 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 33 |
|---|
Most frequent device types declared: 11650UNODENT, 16499.
Authorised representative in the Union: Young Microbrush Ireland Ltd.
Devices declared under this manufacturer
- Air Water Syringe Sleeve 3/4 Sealed
- Barrier Envelope Size 2
- Compule Gun Light Grey Unodent
- Half Chair Cover - Unodent
- Headrest Cover - Unodent
- Headrest Cover Pegasus
- Mouth Prop - Large Unodent
- Mouth Prop - Medium Unodent
- Mouth Props - Assorted (Small, Medium and Large)
- Sticky Film Clear Pegasus
- Tray Sleeve - Unodent
- Tray Sleeve Pegasus
Showing 12 of 33 declared devices.
Catalogue references include 16497UNODENT, 16498UNODENT, 16499, 17100PEGASUS, 17101PEGASUS, 17105PEGASUS.
European nomenclature codes declared: T030199, Q010599, Q010199.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 33 |
| 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 | 33 |
|---|---|
| Found in the U.S. device database | 3 |
| Share | 9.1 % |
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. Astek Innovations Ltd was not found in either the U.S. or the Canadian register.