Isol8 Healthcare Ltd
IE-MF-000012420 · Ireland · Ballincollig, Co. Cork
Isol8 Healthcare Ltd is registered in the European database on medical devices as a manufacturer, with 84 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 84 |
|---|
Most frequent device types declared: ISOL/8 Theatre Headwear (Comfort and Basics Ranges), FLUIDSAFE Surgical Mask, Warming Jackets, ISOL/8 Shoe Covers, ISOL/8 SMS Medical Gown.
Among these devices, 34 are declared sterile.
No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 84 |
| Country of registration | Ireland |
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.