ABIGO Medical AB
SE-MF-000000736 · Sweden · Askersund
ABIGO Medical AB is registered in the European database on medical devices as a manufacturer, with 32 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIb | 32 |
|---|
Among these devices, 32 are declared sterile.
Devices declared under this manufacturer
- Cutimed Sorbact Ribbon
- Cutimed Sorbact Ribbon Gauze
- Cutimed Sorbion Sorbact
- Sorbact Ribbon
- Sorbact Superabsorbent
Showing 12 of 32 declared devices.
Catalogue references include 72698-48, 72698-49, 72698-60, 72698-67, 72698-68, 72698-70.
European nomenclature codes declared: M040416.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | ABIGO MEDICAL AB (SE) · FDA 8043991 |
| Devices in EUDAMED | 32 |
| Country of registration | Sweden |
Device-level evidence
| Devices with a numeric GTIN | 32 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | ABIGO MEDICAL AB |
What it holds in Canada
| Licences on record | 11 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 11 |
| First licensed | 2023-02-24 |
Licence types: Device Family (11).
Licensed under: CUTIMED SORBACT GEL, CUTIMED SORBACT SWAB, CUTIMED SORBACT DRESSING PAD, CUTIMED SORBACT RIBBON GAUZE, LEUKOMED SORBACT, CUTIMED SORBION SORBACT.
North American profile: Both markets. ABIGO Medical AB is registered in both the United States and Canada.