IVDR IVDR QMS Issued

IQMS/00002/0v001

Manufacturer: GENSPEED Biotech
Basic UDI-DIs
0
Scopes
1
Preceding Certs
0
Risk Classes
1
Characteristics
0
Revision
v001
1183
Valid for 1183 days
Expiry: September 4, 2029

Basic Information

Number
IQMS/00002/0v001
Type
IVDR QMS
Legislation
IVDR
Issue Date
September 5, 2024
Expiry Date
September 4, 2029
Revision
v001
Manufacturer
GENSPEED Biotech

Certificate Lifecycle

September 5, 2024 September 4, 2029

Scopes

Quality Procedure Scope

Device Group Class B

IVR 0609 - Other devices intended to be used to define or monitor physiological status and therapeutic measures

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.