Certificate ECM24MDR007

Certificate number

ECM24MDR007

Certificate type

Quality management system

Certificate status

Supplemented

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Version

2

Certificate ID

1282ECM24MDR0071

Issued

Jul 17, 2025

Valid from

Jul 17, 2025

Valid until

Sep 8, 2029

Notified body

ENTE CERTIFICAZIONE MACCHINE SRL

Notified body SRN

1282

Notified body country

Italy

No specific devices are listed for this certificate.

Sterile

Yes

Human tissues

No

Animal tissues

No

In vitro diagnostics

No

Initial registration

No

New device

No

Discard allowed

No

SSCP enabled

Yes

Mechanism of scrutiny

No

Intended medical purpose

No

SPP applicable

No

Conditions applicable

No

MOS outside EUDAMED

No

QMS/MOS type

Class IIb only