MDR MDR QMS Issued

HZ 2029635-1

Basic UDI-DIs
0
Scopes
2
Preceding Certs
0
Risk Classes
2
Characteristics
0
Revision
Rev.1
546
Valid for 546 days
Expiry: December 6, 2027

Basic Information

Number
HZ 2029635-1
Type
MDR QMS
Legislation
MDR
Issue Date
August 22, 2023
Expiry Date
December 6, 2027
Revision
Rev.1

Certificate Lifecycle

August 22, 2023 December 6, 2027

Scopes

2 scopes covering 2 risk classes

Quality Procedure Scope

Device Group Class IIa

Z121101 - INSTRUMENTS FOR DENTAL TREATMENT UNITS

Quality Procedure Scope

Device Group Class IIb

Z110304 - DIAGNOSTIC AND INTERVENTIONAL RADIOLOGY INSTRUMENTS INSTRUMENTS FOR ENDORAL RADIOLOGY

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.