IVDR IVDR QMS Issued

HX 1624072-1

Manufacturer: Seramun Diagnostica GmbH
Basic UDI-DIs
0
Scopes
1
Preceding Certs
0
Risk Classes
1
Characteristics
0
Revision
Rev. 0

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1169
Valid for 1169 days
Expiry: October 8, 2029

Basic Information

Number
HX 1624072-1
Type
IVDR QMS
Legislation
IVDR
Issue Date
October 9, 2024
Expiry Date
October 8, 2029
Revision
Rev. 0

Certificate Lifecycle

October 9, 2024 October 8, 2029

Scopes

Quality Procedure Scope

Device Group Class B

INFECTIOUS DISEASES IVR 0503: Devices intended to be used to detect the presence of, or exposure to an infectious agent including sexually transmitted agents W01050104 - HELICOBACTER PYLORI

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.