MDR MDR QMS Issued

2024-MDR/QS-032

Basic UDI-DIs
0
Scopes
3
Preceding Certs
0
Risk Classes
1
Characteristics
0
Revision
0
1119
Valid for 1119 days
Expiry: July 1, 2029

Basic Information

Number
2024-MDR/QS-032
Type
MDR QMS
Legislation
MDR
Issue Date
July 1, 2024
Expiry Date
July 1, 2029

Certificate Lifecycle

July 1, 2024 July 1, 2029

Device Characteristics

Sterile

Scopes

3 scopes covering 1 risk classes

Quality Procedure Scope

Device Group Class IIb

P09120102: Anchors, tendon and ligament synthesis

Quality Procedure Scope

Device Group Class IIb

H9007: Anchors for soft tissue suture (excluding p09120102 anchors for tendon-ligament synthesis)

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.