MDR MDR QMS Issued

FI23/00000052

Manufacturer: PAUSCH Medical GmbH
Basic UDI-DIs
0
Scopes
3
Preceding Certs
0
Risk Classes
2
Characteristics
0
Revision
Issue 1

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820
Valid for 820 days
Expiry: October 24, 2028

Basic Information

Number
FI23/00000052
Type
MDR QMS
Legislation
MDR
Issue Date
October 25, 2023
Expiry Date
October 24, 2028
Revision
Issue 1
Manufacturer
PAUSCH Medical GmbH

Certificate Lifecycle

October 25, 2023 October 24, 2028

Scopes

3 scopes covering 2 risk classes

Quality Procedure Scope

Device Group Class IIa

U99 Devices for Urogenital System - Other

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.