Certificate EPT 0477.MDR.24/5405

Certificate number

EPT 0477.MDR.24/5405

Certificate type

Technical documentation

Certificate status

Issued

Applicable legislation

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

Version

1

Certificate ID

0477EPT 0477.MDR.24/5405

Issued

Mar 7, 2024

Valid from

Mar 7, 2024

Valid until

Mar 6, 2029

Manufacturer

Enzymatica AB

Manufacturer SRN

SE-MF-000002254

Manufacturer country

Sweden

Notified body

Eurofins Product Testing Italy S.r.l.

Notified body SRN

0477

Notified body country

Italy

• ColdZymeClass III
  73400311CZMSJE

Sterile

—

Human tissues

—

Animal tissues

—

In vitro diagnostics

—

Initial registration

Yes

New device

No

Discard allowed

No

SSCP enabled

Yes

Mechanism of scrutiny

No

Intended medical purpose

—

SPP applicable

—

Conditions applicable

No

MOS outside EUDAMED

—

QMS/MOS type

Others

No status changes or preceding certificates are recorded.