Basic UDI-DIs
0
Scopes
3
Preceding Certs
0
Risk Classes
1
Characteristics
0
Revision
Issue 1
70
Expired 70 days ago
Expiry: March 30, 2026
Basic Information
- Number
- FI23/00000013
- Type
- MDR QMS
- Legislation
- MDR
- Issue Date
- March 31, 2023
- Expiry Date
- March 30, 2026 Expired
- Revision
- Issue 1
- Manufacturer
- Gründler GmbH
Certificate Lifecycle
March 31, 2023
March 30, 2026
Conditions
English
PMCF investigation is to be planned and conducted for the Ventilution Base Device 150i and Ventilution Patient Set Standard.
Scopes
3 scopes covering 1 risk classes
Quality Procedure Scope
Device Group
Class IIa
Respiratory and Anaesthesia Devices
Quality Procedure Scope
Device
Class IIa
Quality Procedure Scope
Device
Class IIa
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.