Certificate M.2022.MDR.1008

Certificate number

M.2022.MDR.1008

Certificate type

Quality assurance

Certificate status

Issued

Applicable legislation

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

Version

1

Certificate ID

2696M.2022.MDR.10080

Issued

Dec 12, 2022

Valid from

Dec 12, 2022

Valid until

Dec 11, 2027

Manufacturer

Lentismed d.o.o.

Manufacturer SRN

HR-MF-000018298

Manufacturer country

Croatia

Notified body

UDEM Adriatic d.o.o.

Notified body SRN

2696

Notified body country

Croatia

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

No

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.