Certificate 1434-MDR-007/2024

Certificate number

1434-MDR-007/2024

Certificate type

Quality management system

Certificate status

Issued

Applicable legislation

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

Version

1

Certificate ID

14341434-MDR-007/20241/12.07.2024/S 713/714/BM/2022

Issued

Jul 12, 2024

Valid from

Jul 12, 2024

Valid until

Jul 11, 2029

Manufacturer

TRICOMED S.A.

Manufacturer SRN

PL-MF-000002483

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

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

Yes

SPP applicable

No

Conditions applicable

No

MOS outside EUDAMED

—

QMS/MOS type

Others

No status changes or preceding certificates are recorded.