Basic UDI-DIs
0
Scopes
9
Preceding Certs
0
Risk Classes
2
Characteristics
0
Revision
0
523
Valid for 523 days
Expiry: November 14, 2027
Basic Information
- Number
- 1000165613
- Type
- MDR QMS
- Legislation
- MDR
- Issue Date
- February 22, 2024
- Expiry Date
- November 14, 2027
- Manufacturer
- Acutus Medical, Inc.
Certificate Lifecycle
Today
February 22, 2024
November 14, 2027
Scopes
9 scopes covering 2 risk classes
Quality Procedure Scope
Device
Class IIb
Quality Procedure Scope
Device
Class III
Quality Procedure Scope
Device
Class III
Quality Procedure Scope
Device
Class III
Quality Procedure Scope
Device Group
Class IIb
MDA 0202 - Active non-implantable imaging devices utilising non-ionizing radiation
Quality Procedure Scope
Device Group
Class III
MDA 0202 - Active non-implantable imaging devices utilising non-ionizing radiation
Quality Procedure Scope
Device Group
Class III
MDN 1203 - Non-active non-implantable guide catheters, balloon catheters, guidewires, introducers, filters, and related tools
Quality Procedure Scope
Device
Class III
Quality Procedure Scope
Device
Class IIb
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.