Basic UDI-DIs
0
Scopes
2
Preceding Certs
0
Risk Classes
1
Characteristics
0
Revision
Issue 1
10
Expired 10 days ago
Expiry: May 30, 2026
Basic Information
- Number
- FI20/00000020
- Type
- MDR QMS
- Legislation
- MDR
- Issue Date
- May 31, 2023
- Expiry Date
- May 30, 2026 Expired
- Revision
- Issue 1
- Manufacturer
- Disior Oy
Certificate Lifecycle
May 31, 2023
May 30, 2026
Conditions
English
Additional testing is required to be done as defined in the certification decision.
Scopes
2 scopes covering 1 risk classes
Quality Procedure Scope
Device
Class IIa
Quality Procedure Scope
Device Group
Class IIa
Software tool for orthopedic anatomy characterization
Basic UDI-DIs
This Certificate doesn't seem to be associated with any Basic UDI-DIs. If you think that sounds weird, so do we. But that's what the EUDAMED data seems to state.