Basic UDI-DIs
0
Scopes
5
Preceding Certs
1
Risk Classes
1
Characteristics
0
Revision
Issue 6
398
Expired 398 days ago
Expiry: May 7, 2025
Basic Information
- Number
- FI22/871878
- Type
- MDR QMS
- Legislation
- MDR
- Issue Date
- May 3, 2024
- Expiry Date
- May 7, 2025 Expired
- Revision
- Issue 6
- Manufacturer
- Combinostics Oy
Certificate Lifecycle
May 3, 2024
May 7, 2025
Scopes
5 scopes covering 1 risk classes
Quality Procedure Scope
Device
Class IIa
Quality Procedure Scope
Device Group
Class IIa
Medical software for clinical decision support, automatic segmentation and quantification of human brain images
Quality Procedure Scope
Device
Class IIa
Quality Procedure Scope
Device
Class IIa
Quality Procedure Scope
Device
Class IIa
Preceding Certificates
FI22/871878
Supplemented
Issued: December 12, 2023
Expires: May 7, 2025
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.