Certificate ES23/00000553

Certificate number

ES23/00000553

Certificate type

Quality management system

Certificate status

Issued

Applicable legislation

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

Version

1

Certificate ID

1639ES23/000005531

Issued

May 30, 2023

Valid from

May 30, 2023

Valid until

May 30, 2028

Manufacturer

CARDIVAIS S.A.

Manufacturer SRN

ES-MF-000017980

Manufacturer country

Spain

Notified body

SGS Belgium NV

Notified body SRN

1639

Notified body country

Belgium

No specific devices are listed for this certificate.

Sterile

Yes

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.