MDR MDR QMS Issued

24 0145 QR/NB

Manufacturer: BIOSTER, a.s.
Basic UDI-DIs
0
Scopes
7
Preceding Certs
0
Risk Classes
1
Characteristics
0
Revision
0
1055
Valid for 1055 days
Expiry: April 28, 2029

Basic Information

Number
24 0145 QR/NB
Type
MDR QMS
Legislation
MDR
Issue Date
April 29, 2024
Expiry Date
April 28, 2029
Manufacturer
BIOSTER, a.s.

Certificate Lifecycle

April 29, 2024 April 28, 2029

Device Characteristics

Sterile

Scopes

7 scopes covering 1 risk classes

Quality Procedure Scope

Device Group Class III

Polysaccharide haemostatic dressing

Quality Procedure Scope

Device Class III

Quality Procedure Scope

Device Class III

Quality Procedure Scope

Device Class III

Quality Procedure Scope

Device Class III

Quality Procedure Scope

Device Class III

Quality Procedure Scope

Device Class III

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.