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: FLUIDSAFE Surgical Mask, ISOL/8 Elemental Poly-reinforced Surgical Gown XXXL, ISOL/8 Elemental Standard Surgical Gown L, ISOL/8 Elemental Standard Surgical Gown M, ISOL/8 Elemental Standard Surgical Gown XL.
Among these devices, 34 are declared sterile.
Devices declared under this manufacturer
- ISOL/8
Showing 12 of 84 declared devices.
Catalogue references include IS8E14, IS8HB02, IS8HB05Y, IS8HB06, IS8HC05, IS8SG02.
European nomenclature codes declared: T0207, T020401, T020604, T020402, T020499, T0299.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 84 |
| Country of registration | Ireland |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 84 |
|---|---|
| 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. Isol8 Healthcare Ltd was not found in either the U.S. or the Canadian register.