Basic UDI-DIs
0
Scopes
4
Preceding Certs
0
Risk Classes
2
Characteristics
0
Revision
Rev. 0
707
Valid for 707 days
Expiry: May 15, 2028
Basic Information
- Number
- HX 1038121-1
- Type
- IVDR QMS
- Legislation
- IVDR
- Issue Date
- May 16, 2023
- Expiry Date
- May 15, 2028
- Revision
- Rev. 0
- Manufacturer
- MACHEREY-NAGEL GmbH & Co. KG
Certificate Lifecycle
Today
May 16, 2023
May 15, 2028
Scopes
4 scopes covering 2 risk classes
Quality Procedure Scope
Device Group
Class B
IVR 608: W01010602 URINE TESTING (CC) - RT & POC
Quality Procedure Scope
Device Group
Class B
Products of class B, for near-patient testing: IVR 608: W01010602 URINE TESTING (CC) - RT & POC W01010699 CLIN. CHEM. RT & POC - OTHER
Quality Procedure Scope
Device Group
Class B
Products of class B, for self-testing: IVR 608: W01010602 URINE TESTING (CC) - RT & POC
Quality Procedure Scope
Device Group
Class C
Products of class C, for self-testing: IVR 608: W01010602 URINE TESTING (CC) - RT & POC
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.