Basic UDI-DIs
0
Scopes
2
Preceding Certs
1
Risk Classes
2
Characteristics
0
Revision
Rev. 1
273
Valid for 273 days
Expiry: March 8, 2027
Basic Information
- Number
- HX 1037243-1
- Type
- IVDR QMS
- Legislation
- IVDR
- Issue Date
- August 22, 2023
- Expiry Date
- March 8, 2027
- Revision
- Rev. 1
- Decision Date
- October 1, 2024
- Manufacturer
- Bio-Rad Medical Diagnostics GmbH
Certificate Lifecycle
Today
August 22, 2023
March 8, 2027
Scopes
2 scopes covering 2 risk classes
Quality Procedure Scope
Device Group
Class C
HAEMATOLOGY / HAEMOSTASIS / IMMUNOHAEMATOLOGY / HISTOLOGY / CYTOLOGY IVR 0106 Other devices intended to be used for blood grouping W01030302 - RHESUS TYPING
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)] W01030305 - OTHER ANTIGEN TYPING
Preceding Certificates
HX 1037243-1
Supplemented
Issued: August 22, 2023
Expires: March 8, 2027
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.