MDR MDR QMS Issued

029-00-00-MDR

Manufacturer: CIZETA SURGICAL S.r.l.
Basic UDI-DIs
0
Scopes
5
Preceding Certs
0
Risk Classes
2
Characteristics
0
Revision
0
829
Valid for 829 days
Expiry: September 14, 2028

Basic Information

Number
029-00-00-MDR
Type
MDR QMS
Legislation
MDR
Issue Date
September 15, 2023
Expiry Date
September 14, 2028
Manufacturer
CIZETA SURGICAL S.r.l.

Certificate Lifecycle

September 15, 2023 September 14, 2028

Device Characteristics

Sterile

Scopes

5 scopes covering 2 risk classes

Quality Procedure Scope

Device Group Class IIb

Non-active osteo- and orthopaedic implants

Quality Procedure Scope

Device Group Class IIa

Non-active non-implantable instruments

Quality Procedure Scope

Device Class IIb

Quality Procedure Scope

Device Class IIa

Quality Procedure Scope

Device Class IIb

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.