Certificate TNP/MDR/0041/5915/2025

Certificate number

TNP/MDR/0041/5915/2025

Certificate type

Quality management system

Certificate status

Issued

Applicable legislation

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

Version

1

Certificate ID

2274TNP/MDR/0041/5915/2025Ver. 01

Issued

Sep 11, 2025

Valid from

Sep 11, 2025

Valid until

Sep 10, 2028

Manufacturer

SynexCare sp. z o.o.

Manufacturer SRN

PL-MF-000038028

Manufacturer country

Poland

Notified body

TUV NORD Polska Sp. z o.o

Notified body SRN

2274

Notified body country

Poland

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

Yes

Intended medical purpose

No

SPP applicable

No

Conditions applicable

Yes

MOS outside EUDAMED

—

QMS/MOS type

Basic UDI-DI data and Class IIb

No status changes or preceding certificates are recorded.