Basic UDI-DIs
0
Scopes
2
Preceding Certs
0
Risk Classes
2
Characteristics
0
Revision
2
180
Expires in 180 days
Expiry: December 5, 2026
Basic Information
- Number
- HZ 2049089-1
- Type
- MDR QMS
- Legislation
- MDR
- Issue Date
- April 27, 2024
- Expiry Date
- December 5, 2026
- Revision
- 2
- Manufacturer
- GE HUALUN MEDICAL SYSTEMS CO. Ltd
Certificate Lifecycle
Today
April 27, 2024
December 5, 2026
Scopes
2 scopes covering 2 risk classes
Quality Procedure Scope
Device Group
Class IIa
Z110690 - Various Digital Bioimaging Management Instruments
Quality Procedure Scope
Device Group
Class IIb
Z110311 - Diagnostic and Interventional Radiology Instruments Direct Digital Radiology (DR) Systems Z110390 - Diagnostic and Interventional Radiology Instruments Various Instruments for Radiodiagnostics and Interventional Procedures
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.