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
- Manufacturer
- Seramun Diagnostica GmbH
Certificate Lifecycle
Today
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.