Certificate HZ 2706025-1

Certificate number

HZ 2706025-1

Certificate type

Quality management system

Certificate status

Issued

Applicable legislation

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

Version

1

Certificate ID

0197HZ 2706025-10

Issued

Oct 20, 2025

Valid from

Oct 20, 2025

Valid until

Jul 17, 2027

Manufacturer

Comarch HIS Sp. z o.o.

Manufacturer SRN

PL-MF-000049883

Manufacturer country

Poland

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

Yes

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

No status changes or preceding certificates are recorded.