MDR MDR QMS Issued

HZ 2185282-1

Basic UDI-DIs
0
Scopes
2
Preceding Certs
0
Risk Classes
2
Characteristics
0
Revision
0
1044
Valid for 1044 days
Expiry: April 17, 2029

Basic Information

Number
HZ 2185282-1
Type
MDR QMS
Legislation
MDR
Issue Date
April 18, 2024
Expiry Date
April 17, 2029

Certificate Lifecycle

April 18, 2024 April 17, 2029

Device Characteristics

Sterile

Scopes

2 scopes covering 2 risk classes

Quality Procedure Scope

Device Group Class IIa

H02030104 - SINGLE PATIENT STRAIGHT LINEAR STAPLERS FOR VIDEOSURGERY H02020101 - STRAIGHT LINEAR STAPLERS FOR OPEN SURGERY

Quality Procedure Scope

Device Group Class IIb

H02030106 - LINEAR STAPLERS FOR VIDEOSURGERY LINEAR STAPLER CARTRIDGES FOR VIDEOSURGERY H02020103 - LINEAR STAPLERS, OPEN SURGERY SINGLE-PATIENT LINEAR SUTURE CARTDRIGES FOR OPEN SURGERY

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.