Certificate 2024-MDR/QS-030

Certificate number

2024-MDR/QS-030

Certificate type

Quality management system

Certificate status

Issued

Applicable legislation

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

Version

1

Certificate ID

22652024-MDR/QS-0300

Issued

Jun 19, 2024

Valid from

Jun 19, 2024

Valid until

Jun 19, 2029

Manufacturer

EMS Handels Gesellschaft m.b.H.

Manufacturer SRN

AT-MF-000002599

Manufacturer country

Austria

Notified body

3EC International a.s.

Notified body SRN

2265

Notified body country

Slovakia

Sterile

No

Human tissues

No

Animal tissues

No

In vitro diagnostics

No

Initial registration

Yes

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

—

QMS/MOS type

Basic UDI-DI data only

No status changes or preceding certificates are recorded.