Basic UDI-DIs
0
Scopes
2
Preceding Certs
1
Risk Classes
2
Characteristics
0
Revision
5
716
Valid for 716 days
Expiry: May 25, 2028
Basic Information
- Number
- HX 1191616-1
- Type
- IVDR QMS
- Legislation
- IVDR
- Issue Date
- November 10, 2023
- Expiry Date
- May 25, 2028
- Revision
- 5
- Manufacturer
- IMMUCOR Medizinische Diagnostik GmbH
Certificate Lifecycle
Today
November 10, 2023
May 25, 2028
Scopes
2 scopes covering 2 risk classes
Quality Procedure Scope
Device Group
Class D
HAEMATOLOGY / HAEMOSTASIS / IMMUNOHAEMATOLOGY / HISTOLOGY / CYTOLOGY IVR 0103 Devices intended to determine markers of the Kell system [Kel1 (K)] W0103030501 - OTHER ANTIGEN TYPING REAGENTS
Quality Procedure Scope
Device Group
Class C
HAEMATOLOGY / HAEMOSTASIS / IMMUNOHAEMATOLOGY / HISTOLOGY / CYTOLOGY IVR 101: Devices intended to determine markers of the ABO system [A (ABO1), B (ABO2), AB (ABO3)] W0103030102 - ABO SERA
Preceding Certificates
HX 1191616-1
Supplemented
Issued: October 30, 2023
Expires: May 25, 2028
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.