MDR MDR QMS Supplemented

HZ 1169866-1

Manufacturer: Ziehm Imaging GmbH
Basic UDI-DIs
0
Scopes
7
Preceding Certs
1
Risk Classes
1
Characteristics
0
Revision
Rev.00
765
Valid for 765 days
Expiry: July 13, 2028

Basic Information

Number
HZ 1169866-1
Type
MDR QMS
Legislation
MDR
Issue Date
July 13, 2023
Expiry Date
July 13, 2028
Validity Start
October 12, 2023
Revision
Rev.00
Manufacturer
Ziehm Imaging GmbH

Certificate Lifecycle

July 13, 2023 July 13, 2028

Scopes

7 scopes covering 1 risk classes

Quality Procedure Scope

Device Group Class IIb

Z110390 - DIAGNOSTIC AND INTERVENTIONAL RADIOLOGY INSTRUMENTS VARIOUS INSTRUMENTS FOR RADIODIAGNOSTICS AND INTERVENTIONAL PROCEDURES

Quality Procedure Scope

Device Class IIb

Quality Procedure Scope

Device Class IIb

Quality Procedure Scope

Device Class IIb

Quality Procedure Scope

Device Class IIb

Quality Procedure Scope

Device Class IIb

Quality Procedure Scope

Device Class IIb

Preceding Certificates

HZ 1169866-1 Issued
Issued: July 14, 2023 Expires: July 13, 2028

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.