Certificate 23M00082CRT01

Certificate number

23M00082CRT01

Certificate type

Quality management system

Certificate status

Issued

Applicable legislation

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

Version

1

Certificate ID

191223M00082CRT01

Issued

Jan 15, 2024

Valid from

Jan 15, 2024

Valid until

Jan 15, 2029

Manufacturer

ArtiQ NV

Manufacturer SRN

BE-MF-000000314

Manufacturer country

Belgium

Notified body

Kiwa Assurance B.V.

Notified body SRN

1912

Notified body country

Netherlands

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.