Certificate SCAR-18.2.1.1

Certificate number

SCAR-18.2.1.1

Certificate type

Quality management system

Certificate status

Amended

Applicable legislation

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

Version

1

Certificate ID

3022SCAR-18.2.1.1

Issued

May 26, 2026

Valid from

May 26, 2026

Valid until

Jul 24, 2030

Manufacturer

Health Triage S.p.A.

Manufacturer SRN

IT-MF-000030843

Manufacturer country

Italy

Notified body

Scarlet NB B.V.

Notified body SRN

3022

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

Class IIb only