MDR MDR QMS Issued

037-00-00-MDR

Basic UDI-DIs
0
Scopes
2
Preceding Certs
0
Risk Classes
1
Characteristics
0
Revision
00
917
Valid for 917 days
Expiry: December 12, 2028

Basic Information

Number
037-00-00-MDR
Type
MDR QMS
Legislation
MDR
Issue Date
December 13, 2023
Expiry Date
December 12, 2028
Revision
00

Certificate Lifecycle

December 13, 2023 December 12, 2028

Scopes

2 scopes covering 1 risk classes

Quality Procedure Scope

Device Group Class IIb

orally administered devices for the therapy of gastro-intestinal disorders

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.