Certificate HZ 1624046-1

Certificate number

HZ 1624046-1

Certificate type

Quality management system

Certificate status

Supplemented

Applicable legislation

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

Version

2

Certificate ID

0197HZ 1624046-1Rev.2

Issued

Apr 15, 2025

Valid from

Apr 15, 2025

Valid until

Oct 9, 2025

Manufacturer

GETEMED Medizin- und Informationstechnik AG

Manufacturer SRN

DE-MF-000012384

Manufacturer country

Germany

Notified body

TÜV Rheinland LGA Products GmbH

Notified body SRN

0197

Notified body country

Germany

No specific devices are listed for this certificate.

Sterile

No

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

Yes

Intended medical purpose

No

SPP applicable

No

Conditions applicable

No

MOS outside EUDAMED

—

QMS/MOS type

Class IIb only