Osstell AB
SE-MF-000002162 · Sweden · Göteborg
Osstell AB is registered in the European database on medical devices as a manufacturer, with 142 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 142 |
|---|
Most frequent device types declared: Osstell Beacon, Osstell Beacon Im, Reusable SmartPeg, Single-use SmartPeg, SmartPeg Mount.
Among these devices, 112 are declared sterile, 7 active, 4 with a measuring function.
Devices declared under this manufacturer
- Osstell Beacon
- Osstell IDx
- SmartPeg Type 023R
- SmartPeg Type 09
- SmartPeg Type 10
- SmartPeg Type 111
- SmartPeg Type 117 MegaGen
- SmartPeg Type 118
- SmartPeg Type 12
- SmartPeg Type 27
- SmartPeg Type 47
- SmartPeg Type 52 -Neoss Access
Showing 12 of 142 declared devices.
Catalogue references include 08086154, 08086423, 100359, 100368, 100370, 100771.
European nomenclature codes declared: Q0199.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | OSSTELL AB (SE) · FDA 3004070020 |
| Devices in EUDAMED | 142 |
| Country of registration | Sweden |
Device-level evidence
| Devices with a numeric GTIN | 141 |
|---|---|
| Found in the U.S. device database | 116 |
| Share | 82.3 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | OSSTELL AB |
What it holds in Canada
| Licences on record | 3 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 3 |
| First licensed | 2008-07-29 |
Licence types: Device Family (1), System (1), Device Group Family (1).
Licensed under: SMARTPEG, OSSTELL IDX, OSSTELL BEACON.
North American profile: Both markets. Osstell AB is registered in both the United States and Canada.