Certificate MDR-0031

Certificate number

MDR-0031

Certificate type

Quality management system

Certificate status

Issued

Applicable legislation

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

Version

1

Certificate ID

1304MDR-00311

Issued

Oct 13, 2025

Valid from

Oct 13, 2025

Valid until

Oct 12, 2030

Manufacturer

roclub GmbH

Manufacturer SRN

DE-MF-000046379

Manufacturer country

Germany

Notified body

SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY - SIQ

Notified body SRN

1304

Notified body country

Slovenia

No specific devices are listed for this certificate.

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

Others

No status changes or preceding certificates are recorded.