MDR MDR QMS Issued

2024-MDR/QS-064

Manufacturer: WOLF-Medizintechnik GmbH
Basic UDI-DIs
0
Scopes
5
Preceding Certs
0
Risk Classes
1
Characteristics
0
Revision
00
1257
Valid for 1257 days
Expiry: November 15, 2029

Basic Information

Number
2024-MDR/QS-064
Type
MDR QMS
Legislation
MDR
Issue Date
November 15, 2024
Expiry Date
November 15, 2029
Revision
00

Certificate Lifecycle

November 15, 2024 November 15, 2029

Scopes

5 scopes covering 1 risk classes

Quality Procedure Scope

Device Group Class IIb

Brachytherapy radiation system

Quality Procedure Scope

Device Class IIb

Quality Procedure Scope

Device Class IIb

Quality Procedure Scope

Device Class IIb

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.