Basic UDI-DIs
0
Scopes
8
Preceding Certs
1
Risk Classes
1
Characteristics
0
Revision
Issue 2
820
Valid for 820 days
Expiry: September 5, 2028
Basic Information
- Number
- FI23/1008002
- Type
- MDR QMS
- Legislation
- MDR
- Issue Date
- January 9, 2024
- Expiry Date
- September 5, 2028
- Revision
- Issue 2
- Manufacturer
- Shenzhen Comen Medical Instruments Co.,LTD.
Certificate Lifecycle
Today
January 9, 2024
September 5, 2028
Scopes
8 scopes covering 1 risk classes
Quality Procedure Scope
Device Group
Class IIb
Z1203010504 Adult and Paediatric / Neonatal Pulmonary Ventilators
Quality Procedure Scope
Device Group
Class IIb
Z1203010503 Neonatal / Paediatric Pulmonary Ventilators
Quality Procedure Scope
Device
Class IIb
Quality Procedure Scope
Device
Class IIb
Quality Procedure Scope
Device
Class IIb
Quality Procedure Scope
Device
Class IIb
Quality Procedure Scope
Device Group
Class IIb
EMDN: Z12030502 MANUAL DEFIBRILLATORS
Quality Procedure Scope
Device
Class IIb
Preceding Certificates
FI23/1008002
Issued
Issued: September 6, 2023
Expires: September 5, 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.