Serosep Limited
IE-MF-000020322 · Ireland · Limerick
Serosep Limited is registered in the European database on medical devices as a manufacturer, with 49 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
Most frequent device types declared: EBCDA-V2, EBCPE, EBFFS - CDA, EBFFS - CPE, EBFFS - GPDx.
Devices declared under this manufacturer
- EntericBio Gastro Panel 2
- EntericBio Workstation
- EntericBio ® CPE
- EntericBio® C.difficile plug-in
- EntericBio® CPE plug-in
- EntericBio® Clostridioides difficile
- EntericBio® Dx plug-in
- EntericBio® Stool Preparation Solution
- EntericBio® Viral Panel 2
- EntericBio® Viral Panel 2 plug-in
- EntericBio® Viral Panel 3 plug-in
- HistoPot 10% Neutral Buffered Formalin
Showing 12 of 49 declared devices.
Catalogue references include 5070000450, EBSPSA-v2, S10-B-FOR-125TRAY, S10-B-FOR-2.5L T/P, S10-B-FOR-350ML, S10-B-FOR-40TRAY.
European nomenclature codes declared: W05019099, W02050192, W0105070504, W02060199, W0599, W0104080606.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 49 |
| 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 | 49 |
|---|---|
| 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. Serosep Limited was not found in either the U.S. or the Canadian register.