GAELTEC DEVICES LTD
This firm is named on 2 FDA import alerts in United Kingdom. Shipments from a listed firm may be detained at the port without physical examination. The oldest listing dates to 14 August 2018.
- 2import alerts now
- 8years since the first listing
- 0listings come off
- 30 Augustcopy checked, 2026
Every alert naming this firm
Source: FDA import alerts, mirrored 30 August 2026 · newest listing first
| Alert | Subject | Country | Listed since |
|---|---|---|---|
| 89-04 | Devices from Firms that Have not met Device Quality System Requirements73----- · 74----- · 76----- · 77----- · 78----- · 79----- | United Kingdom | 14 August 20188 yr |
| 89-08 | Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)73----- · 74----- · 76----- · 77----- · 78----- · 79----- | United Kingdom | 14 August 20188 yr |
Product classes covered
A listing does not cover everything the factory makes — it covers the FDA product codes named on the alert. These are the codes attached to this firm, with the class FDA prints for each.
| Code | Product class |
|---|---|
| 73----- | Anesthesiology |
| 74----- | Cardiovascular |
| 76----- | Dental |
| 77----- | Ear,Nose And Throat |
| 78----- | Gastroenterological & Urological |
| 79----- | General & Plastic Surgery |
Why this matters under FSVP
If you import this firm's food into the United States, the FSVP rule makes you re-evaluate the supplier when new information comes to light about its performance. An import alert listing is exactly that kind of information. What FSVP requires and where this fits.
This page exists because the firm was on more than one alert when we first saw it, on 30 August 2026. It stays even after the listings come off, because FDA does not publish removals. What moved lately · check another supplier.