Certificate ITH 1450755 1

Certificate number

ITH 1450755 1

Certificate type

Quality management system

Certificate status

Supplemented

Applicable legislation

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

Version

6

Certificate ID

1936ITH 1450755 15.0

Issued

Feb 26, 2025

Valid from

Feb 26, 2025

Valid until

Dec 28, 2027

Manufacturer

Digitec S.r.l.

Manufacturer SRN

IT-MF-000007792

Manufacturer country

Italy

Notified body

TUV Rheinland Italia SRL

Notified body SRN

1936

Notified body country

Italy

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