Bioretec Oy
Country not established
Part of Bioretec Ltd.
Bioretec Oy is a medical device manufacturer, with 473 devices listed in FDA GUDID and EUDAMED (FDA Class II and I) as of 13 Nov 2026.
- Devices
- 473
Registry facts
- Registries
- FDA GUDID 473
- EUDAMED 2
- Device classes
- FDA Class II 323
- FDA Class I 150
- Sites and related companies
- Identifiers
- DUNS 368715301
What Bioretec Oy makes
Bioretec Oy manufactures bioabsorbable orthopaedic fixation devices, including screws, pins, and wires designed for internal bone stabilization. Their product line also covers reusable surgical instruments such as fluted drill bits, impactors, screwdrivers, taps, and drill guides, primarily for orthopaedic procedures. The company produces disposable pin applicators for precise bone fixation applications.
The company’s devices are classified under FDA regulations as Class I and Class II, with most products listed in the FDA’s Unique Device Identifier (UDI) system. These devices are intended for use in the United States, adhering to applicable regulatory standards for medical device authorisation.
Catalogue
Search and filter all 473 devicesShowing 1-50 of 473
Company details
- DUNS number
- 368715301
- sales@bioretec.com
- Phone
- +358207789500
Frequently asked questions
How many devices does Bioretec Oy have in the registry?
The registry currently lists 473 devices for Bioretec Oy. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bioretec Oy's devices?
Among its 50 most recently registered devices, Bioretec Oy has devices listed in EUDAMED (2 devices) and FDA GUDID (50 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Bioretec Oy's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Bioretec Oy's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Bioretec Oy in the registry?
The most recently registered devices listed for Bioretec Oy include ActivaScrew™ B-AS-2712, ActivaScrew™ B-ASC-4590, ActivaScrew™ B-ACC-3520 and ActivaScrew™ B-ACC-3522.