MDR MDR QMS Supplemented

CR-03-1035-840-24 (01)

Manufacturer: DEKO MedTech Oy
Basic UDI-DIs
0
Scopes
3
Preceding Certs
1
Risk Classes
1
Characteristics
0
Revision
01
721
Valid for 721 days
Expiry: May 30, 2028

Basic Information

Number
CR-03-1035-840-24 (01)
Type
MDR QMS
Legislation
MDR
Issue Date
April 30, 2024
Expiry Date
May 30, 2028
Revision
01
Manufacturer
DEKO MedTech Oy

Certificate Lifecycle

April 30, 2024 May 30, 2028

Scopes

3 scopes covering 1 risk classes

Quality Procedure Scope

Device Class IIa

Quality Procedure Scope

Device Group Class IIa

MDA 0317 Active non-implantable devices for cleaning, disinfection and sterilisation

Quality Procedure Scope

Device Class IIa

Preceding Certificates

CR-03-1035-840-24 Amended
Issued: April 30, 2024 Expires: May 30, 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.