Basic UDI-DIs
0
Scopes
5
Preceding Certs
0
Risk Classes
1
Characteristics
1
Revision
0
884
Valid for 884 days
Expiry: November 9, 2028
Basic Information
- Number
- 23 0517 QR/NB
- Type
- MDR QMS
- Legislation
- MDR
- Issue Date
- November 10, 2023
- Expiry Date
- November 9, 2028
- Manufacturer
- GAMA GROUP a.s.
Certificate Lifecycle
Today
November 10, 2023
November 9, 2028
Device Characteristics
Sterile
Scopes
5 scopes covering 1 risk classes
Quality Procedure Scope
Device Group
Class I
Sterile
Infusion sets for gravity feed, Double-ended piercing spike, Venous pressure meters, Flow regulator infusion
Quality Procedure Scope
Device
Class I
Sterile
Quality Procedure Scope
Device
Class I
Sterile
Quality Procedure Scope
Device
Class I
Sterile
Quality Procedure Scope
Device
Class I
Sterile
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.