Basic UDI-DIs
0
Scopes
2
Preceding Certs
0
Risk Classes
2
Characteristics
0
Revision
3
148
Expired 148 days ago
Expiry: January 12, 2026
Basic Information
- Number
- HZ 2069064-1
- Type
- MDR QMS
- Legislation
- MDR
- Issue Date
- October 25, 2021
- Expiry Date
- January 12, 2026 Expired
- Revision
- 3
- Manufacturer
- GE HANGWEI MEDICAL SYSTEMS CO., LTD.
Certificate Lifecycle
October 25, 2021
January 12, 2026
Scopes
2 scopes covering 2 risk classes
Quality Procedure Scope
Device Group
Class IIa
Z110306-COMPUTED TOMOGRAPHY SCANNING SYSTEMS (CT)
Quality Procedure Scope
Device Group
Class IIb
Z110306 - DIAGNOSTIC AND INTERVENTIONAL RADIOLOGY INSTRUMENTS COMPUTED TOMOGRAPHY SCANNING SYSTEMS (CT)
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.