MDR MDR QA Issued

HK23/00000192

Basic UDI-DIs
0
Scopes
4
Preceding Certs
0
Risk Classes
2
Characteristics
1
Revision
1
885
Valid for 885 days
Expiry: November 9, 2028

Basic Information

Number
HK23/00000192
Type
MDR QA
Legislation
MDR
Issue Date
November 9, 2023
Expiry Date
November 9, 2028
Revision
1

Certificate Lifecycle

November 9, 2023 November 9, 2028

Device Characteristics

Sterile

Scopes

4 scopes covering 2 risk classes

Quality Procedure Scope

Device Group Class IIa

MDN1202, MDS1005

Quality Procedure Scope

Device Group Class I Sterile

MDN1208, MDS1005

Quality Procedure Scope

Device Class IIa

Quality Procedure Scope

Device Class I Sterile

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.