Bioretec Ltd.
Active in EUDAMEDFinlandfrom SRN EUDAMED FDA SRN FI-MF-000001328 FEI 3005536892
Bioretec Ltd. is a medical device manufacturer based in Finland, with 282 devices listed in EUDAMED, FDA GUDID and FDA 510(k) (EU Class III, I and IIa; FDA Class II) as of 13 Nov 2026.
- Devices
- 282
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
Registry facts
- Registries
- EUDAMED 273
- FDA GUDID 198
- FDA 510(k) 9
- Device classes
- EU Class III 156
- EU Class I 68
- EU Class IIa 49
- FDA Class II 9
- Top EMDN categories
- Identifiers
- EUDAMED SRN FI-MF-000001328
- FDA FEI 3005536892
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- United States
- FDA establishment
What Bioretec Ltd. makes
Bioretec Ltd. manufactures reusable surgical instruments, including tendon/ligament bone anchors, bone-cutting forceps, and screwdrivers, as well as reusable instrument trays and arthrodesis intramedullary nails. Their portfolio also includes single-use joint prosthesis implantation kits and surgical implant templates, alongside specific screws and countersinks for orthopedic fixation, such as the ActivaScrew™ and ActivaNail™ lines.
The company’s devices are classified under EU Medical Device Regulations as Class I, Class II, Class IIa, and Class III, with corresponding listings in the EUDAQD (eudamed) and FDA’s 510(k) premarket notification database. Bioretec Ltd. is based in Finland.
Catalogue
Search and filter all 282 devicesShowing 1-50 of 282
Company details
- EUDAMED SRN
- FI-MF-000001328
- FDA FEI number
- 3005536892
- EU VAT number
- FI14741969
- EUDAMED status
- Active
- EUDAMED registered name
- Bioretec Ltd.
- Registered address
- 5, Yrittäjänkulma, 33710, Tampere, Finland
- Website
- www.bioretec.com
- sales@bioretec.com
- PRRC contact
- Mari Ruotsalainen
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 1 Oct 2027
DEKRA Certification B.V. 0344 1 certificate
- 2250004CE01 Expiring
Quality management system EU MDR
- Issued
- 4 Sep 2026
- Expires
- 1 Oct 2027
- Reason
- Other
FDA establishments
- Bioretec Oy US
Frequently asked questions
How many devices does Bioretec Ltd. have in the registry?
The registry currently lists 282 devices for Bioretec Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bioretec Ltd.'s devices?
Among its 50 most recently registered devices, Bioretec Ltd. has devices listed in EUDAMED (41 devices), FDA 510(k) (9 devices) and FDA GUDID (29 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Bioretec Ltd.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Bioretec Ltd.'s devices are Class I, Class IIa, Class II and Class III. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Bioretec Ltd.?
EUDAMED lists 1 certificate for Bioretec Ltd. (quality management system) under MDR. The most recent was issued on 4 Sep 2026.
What are the newest devices from Bioretec Ltd. in the registry?
The most recently registered devices listed for Bioretec Ltd. include ACTIVAPIN, ACTIVASCREW, ActivaScrew™ Cannulated COM and ActivaScrew™.
Which FDA establishments are linked to Bioretec Ltd.?
1 FDA establishment is linked to Bioretec Ltd. in the registry; they are listed on the company page.