MDR MDR QMS Supplemented

CSQ0004230523

Basic UDI-DIs
0
Scopes
12
Preceding Certs
1
Risk Classes
1
Characteristics
0
Revision
05
590
Valid for 590 days
Expiry: January 19, 2028

Basic Information

Number
CSQ0004230523
Type
MDR QMS
Legislation
MDR
Issue Date
May 29, 2023
Expiry Date
January 19, 2028
Revision
05

Certificate Lifecycle

May 29, 2023 January 19, 2028

Device Characteristics

Sterile

Scopes

12 scopes covering 1 risk classes

Quality Procedure Scope

Device Group Class III

AUVITA / YaluSTYLE® Auvita + M / YaluSTYLE® + M Auvita + S / YaluSTYLE® + S

Quality Procedure Scope

Device Class III

Quality Procedure Scope

Device Class III

Quality Procedure Scope

Device Class III

Quality Procedure Scope

Device Group Class III

Servator® H sacca PVC-free 1000 ml Servator® H PVC-free bag 1000 ml Servator® H sacca PVC-free 2000 ml Servator® H PVC-free bag 2000 ml Servator® H sacca PVC-free 5000 ml Servator® H PVC-free bag 5000 ml Servator® H flacone vetro 100 ml Servator® H glass bottle 100 ml

Quality Procedure Scope

Device Group Class III

Servator® B sacca PVC-free 1000 ml Servator® B PVC-free bag 1000 ml Servator® B sacca PVC-free 2000 ml Servator® B PVC-free bag 2000 ml

Quality Procedure Scope

Device Class III

Quality Procedure Scope

Device Group Class III

Servator® C sacca PVC-free 1000 ml Servator® C PVC-free bag 1000 ml

Quality Procedure Scope

Device Class III

Quality Procedure Scope

Device Group Class III

Servator® M sacca PVC-free 1000 ml Servator® M PVC-free bag 1000 ml

Quality Procedure Scope

Device Class III

Quality Procedure Scope

Device Group Class III

DENTAHEED/YaluMAX® siringa sterile preriempita in vetro 0.8% (8 mg/ml) da 1 ml DENTAHEED/YaluMAX® siringa sterile preriempita in PP 0.8% (8 mg/ml) da 1 ml

Preceding Certificates

CSQ0004230423 Supplemented
Issued: April 19, 2023 Expires: January 19, 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.