Ostoform Limited
IE-MF-000014357 · Ireland · Mullingar, Westmeath
Ostoform Limited is registered in the European database on medical devices as a manufacturer, with 35 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 35 |
|---|
Devices declared under this manufacturer
- FLOWASSIST Seal
- Ostoform Barrier Extender
- Ostoform Crest Moldable Barrier
- Ostoform FLOWASSIST Closed Pouch
- Ostoform FLOWASSIST Convex Baseplate
- Ostoform FLOWASSIST Convex Drainable Pouch
- Ostoform FLOWASSIST Convex Urostomy Pouch
- Ostoform FLOWASSIST Drainable Pouch
- Ostoform FLOWASSIST Flat Baseplate
- Ostoform FLOWASSIST Urostomy Pouch
- Ostoform Moldable Seal with FLOWASSIST Protection
Showing 12 of 35 declared devices.
Catalogue references include OFA-10011-L, OFA-10012-M, OFA-CB57-S, OFA-DP57, OFA-FB57-M, OFA-FB57-S.
European nomenclature codes declared: A108001, A1002010401, A10020302, A10020402, A1001030202, A1002010402.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | OSTOFORM LTD (IE) · FDA 3015332213 |
| Devices in EUDAMED | 35 |
| Country of registration | Ireland |
Device-level evidence
| Devices with a numeric GTIN | 35 |
|---|---|
| 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: United States only. Ostoform Limited is registered in the United States but was not found in the Canadian register.