AprioMed AB
SE-MF-000001013 · Sweden · Uppsala
AprioMed AB is registered in the European database on medical devices as a manufacturer, with 48 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 48 |
|---|
Among these devices, 48 are declared sterile.
Devices declared under this manufacturer
- AprioCore plus 16G, 13.5 cm
- AprioCore plus 16G, 18.5 cm
- AprioCore plus 16G, 19.5 cm
- AprioCore plus 16G, 8.5 cm
- AprioCore plus 18G, 14.5 cm
- Bonopty Biopsy Set 15G, 13 cm
- Bonopty Extended Drill 13G, 16.5 cm
- Bonopty Extended Drill 15G, 16 cm
- Bonopty Penetration Set 12G, 10 cm
- Bonopty Penetration Set 14G, 13 cm
- Corbo Coaxial Needle 17G, 7 cm
- Gangi-SoftGuard 13G, 7.1 cm
Showing 12 of 48 declared devices.
Catalogue references include 10-1063, 10-1082, 12-1274, ACP16-085-10, ACP16-135-10, ACP16-195-20.
European nomenclature codes declared: A0102010101, A018002, A018099.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | AprioMed AB (SE) · FDA 3007664053 |
| Devices in EUDAMED | 48 |
| Country of registration | Sweden |
Device-level evidence
| Devices with a numeric GTIN | 48 |
|---|---|
| Found in the U.S. device database | 41 |
| Share | 85.4 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | APRIOMED AB |
What it holds in Canada
| Licences on record | 1 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 1 |
| First licensed | 2007-05-24 |
Licence types: System (1).
Licensed under: BONOPTY BONE BIOPSY SYSTEM.
North American profile: Both markets. AprioMed AB is registered in both the United States and Canada.