Certificate 1434-MDR-041/2025

Certificate number

1434-MDR-041/2025

Certificate type

Quality management system

Certificate status

Amended

Applicable legislation

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

Version

2

Certificate ID

14341434-MDR-041/20253/13.04.2026/Z14/2026

Issued

Nov 5, 2025

Valid from

Nov 5, 2025

Valid until

Nov 5, 2030

Manufacturer

Gofarm Sp. z o.o. Sp. k.

Manufacturer SRN

PL-MF-000003485

Manufacturer country

Poland

Notified body

POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

Notified body SRN

1434

Notified body country

Poland

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

No

Intended medical purpose

Yes

SPP applicable

No

Conditions applicable

No

MOS outside EUDAMED

No

QMS/MOS type

Class IIb only