Certificate TNP/MDR/0007/4332/2023

Certificate number

TNP/MDR/0007/4332/2023

Certificate type

Quality management system

Certificate status

Issued

Applicable legislation

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

Version

1

Certificate ID

2274TNP/MDR/0007/4332/2023Ver. 01

Issued

Feb 6, 2023

Valid from

Feb 6, 2023

Valid until

Feb 5, 2026

Manufacturer

Enbio Technology Sp. z o. o.

Manufacturer SRN

PL-MF-000024063

Manufacturer country

Poland

Notified body

TUV NORD Polska Sp. z o.o

Notified body SRN

2274

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

Yes

New device

No

Discard allowed

No

SSCP enabled

Yes

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.