Basic UDI-DIs
0
Scopes
2
Preceding Certs
0
Risk Classes
1
Characteristics
0
Revision
Ver. 01
122
Expired 122 days ago
Expiry: February 6, 2026
Basic Information
- Number
- TNP/MDR/0008/4823/2023
- Type
- MDR QMS
- Legislation
- MDR
- Issue Date
- February 7, 2023
- Expiry Date
- February 6, 2026 Expired
- Revision
- Ver. 01
- Manufacturer
- BRAINSCAN SPÓŁKA AKCYJNA
Certificate Lifecycle
February 7, 2023
February 6, 2026
Scopes
2 scopes covering 1 risk classes
Quality Procedure Scope
Device Group
Class IIa
System wspomagający interpretację badań obrazowych tomografii komputerowej głowy z użyciem metod uczenia maszynowego / A system to support the interpretation of head computed tomography imaging examinations using machine learning methods
Quality Procedure Scope
Device
Class IIa
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.