Disior Oy
Active in EUDAMEDFinlandfrom SRN EUDAMED FDA SRN FI-MF-000002448 FEI 3018064242
Part of Disior, Ltd.
- Devices
- 5
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
EU certificates
1 of 2 in force. 1 certificate has expired.
Market reach
- European Union
- EUDAMED actor, 2 certificates
- United States
- FDA FEI
What Disior Oy makes
Disior Oy makes Bonelogic CMF Orbital, Bonelogic Neuro, and Bonelogic series devices including Bonelogic 1.0, Bonelogic 2, and Bonelogic 2.2, which are used in craniomaxillofacial and neuro applications.
These devices are classified as Class I, Class IIa, and Class IIb under the EU regulatory framework and are listed in the Eudamed database. The company is based in Finland.
Catalogue
- CE MDD EUDAMED
Disior Bonelogic 1.0 Ref Bonelogic Ortho Foot and Ankle
CE MDD, withdrawn EUDAMED- CE MDD EUDAMED
- CE MDD EUDAMEDGUDID
- CE MDR EUDAMEDGUDID
Company details
- EUDAMED SRN
- FI-MF-000002448
- FDA FEI number
- 3018064242
- DUNS number
- 368480395
- EU VAT number
- FI27875878
- EUDAMED status
- Active
- EUDAMED registered name
- Disior Oy
- EUDAMED abbreviated name
- Disior Ltd
- Registered address
- 3, Tammasaarenkatu, 00180, HELSINKI, Finland
- Website
- www.disior.com/
- [email protected]
- Phone
- +358 50 483 6433
- PRRC contact
- Aarno Jussila
EUDAMED certificates
2 certificates1 valid, 1 expiredMDR 2next expiry 30 May 2029
SGS FIMKO OY 0598 2 certificates
- FI23/00000020 Reissued
Quality management system EU MDR
- Issued
- 14 Apr 2026
- Expires
- 30 May 2029
- Valid from
- 31 May 2026
- FI20/00000020 Expired
Quality management system EU MDR
- Issued
- 31 May 2023
- Expires
- 30 May 2026
Frequently asked questions
How many devices does Disior Oy have in the registry?
The registry currently lists 5 devices for Disior Oy. Devices recorded under merged duplicate company entries are counted once.
Which registries list Disior Oy's devices?
Among its 5 most recently registered devices, Disior Oy has devices listed in EUDAMED (5 devices) and FDA GUDID (2 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Disior Oy's devices fall under?
Among its 5 most recently registered devices, the classes recorded for Disior Oy's devices are Class I, Class IIa and Class IIb. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Disior Oy?
EUDAMED lists 2 certificates for Disior Oy (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 2026-04-14.
What are the newest devices from Disior Oy in the registry?
The most recently registered devices listed for Disior Oy include Bonelogic CMF Orbital, Disior Bonelogic 1.0, Bonelogic Neuro and Disior Bonelogic 2.