Bioretec Ltd.
FI-MF-000001328 · Finland · Tampere
Bioretec Ltd. is registered in the European database on medical devices as a manufacturer, with 349 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 173 |
|---|---|
| Class I | 176 |
Most frequent device types declared: B-AI-1128, B-AP-1560, B-AS-4570, B-DI-0515, B-II-0830B.
Among these devices, 178 are declared sterile, 176 implantable, 170 reusable, 1 with a measuring function.
Devices declared under this manufacturer
- Activa Instrument
- ActivaPin™
- ActivaScrew™
- ActivaScrew™ Cannulated
- ActivaScrew™ Cannulated LAG
- ActivaScrew™ Interference
- ActivaScrew™ Interference TCP
- Applicator tip, arthroscopic, for 1.5/2.0 mm nails
- Applicator Ø2.7 mm, reusable, for 2.7 mm pins
- Countersink for RemeOs™ Screw FT 4.0 mm, quick coupling
- Double drill sleeve Ø1.5/2.0 mm, for 2.0mm screws
- Notcher for interference screw
Showing 12 of 349 declared devices.
Catalogue references include B-AS-4570, B-DI-0515, B-II-0830B, B-II-1624, B-IP-3212, B-IRC-3501.
European nomenclature codes declared: P09120606, P09120605, L090999, L0922, L098099, L098003.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | Bioretec Ltd. (FI) · FDA 3005536892 |
| Devices in EUDAMED | 349 |
| Country of registration | Finland |
Device-level evidence
| Devices with a numeric GTIN | 349 |
|---|---|
| Found in the U.S. device database | 265 |
| Share | 75.9 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | BIORETEC LTD |
North American profile: Both markets. Bioretec Ltd. is registered in both the United States and Canada.