CMC HYGEA LTD
IE-MF-000005163 · Ireland · WATERFORD
CMC HYGEA LTD is registered in the European database on medical devices as a manufacturer, with 13 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 13 |
|---|
Most frequent device types declared: CMCBC10001A, CMCD10001A, CMCL10001A, CMCLL10001A, CMCLLV10001A.
Devices declared under this manufacturer
- CMC HYGEA LTD
- PathAguard ABLiS Basin
- PathAguard ABLiS Basin Carrier
- PathAguard ABLiS Basin Liner
- PathAguard LUCA
- PathAguard LUCA Dispenser
- PathAguard LUCA Large
- PathAguard LUCA Liner
- PathAguard LUCA Liner Vessel
- PathAguard LUCA Liner Vessel Carrier
- PathAguard Liner Dispenser
- PathAguard Safesheet
Showing 12 of 13 declared devices.
Catalogue references include CMCBC10001A, CMCD10001A, CMCL10001A, CMCLL10001A, CMCLLV10001A, CMCP10001A.
European nomenclature codes declared: Y093399, V80, V0812.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 13 |
| 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 | 13 |
|---|---|
| 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. CMC HYGEA LTD was not found in either the U.S. or the Canadian register.