MDR MDR QMS Issued

MDR-004

Manufacturer: Biolux Technology GmbH
Basic UDI-DIs
0
Scopes
3
Preceding Certs
0
Risk Classes
1
Characteristics
0
Revision
1
927
Valid for 927 days
Expiry: December 21, 2028

Basic Information

Number
MDR-004
Type
MDR QMS
Legislation
MDR
Issue Date
December 22, 2023
Expiry Date
December 21, 2028
Revision
1
Manufacturer
Biolux Technology GmbH

Certificate Lifecycle

December 22, 2023 December 21, 2028

Scopes

3 scopes covering 1 risk classes

Quality Procedure Scope

Device Group Class IIa

Orthodontic devices - other

Quality Procedure Scope

Device Class IIa

Quality Procedure Scope

Device Class IIa

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.