Enbio Technology Sp. z o. o.

Certificate TNP/MDR/0047/4332/2026

Rev. Ver. 01Reissued

Valid until: Feb 5, 2029

Certificate TNP/MDR/0047/4332/2026 is a valid Quality management system issued to Enbio Technology Sp. z o. o. and registered in EUDAMED. Valid until February 5, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: TNP/MDR/0047/4332/2026
Certificate type: Quality management system
Certificate status: Reissued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 2274TNP/MDR/0047/4332/2026Ver. 01

Validity

Issued: Feb 3, 2026
Valid from: Feb 6, 2026
Valid until: Feb 5, 2029

Manufacturer

Manufacturer: Enbio Technology Sp. z o. o.
Manufacturer SRN: PL-MF-000024063
Manufacturer country: Poland

Notified body

Notified body: TUV NORD Polska Sp. z o.o
Notified body SRN: 2274
Notified body country: Poland

Covered devices

No specific devices are listed for this certificate.

Characteristics

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: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Others

History

Supersedes

TNP/MDR/0007/4332/2023Quality management systemIssuedFeb 6, 2023 → Feb 5, 2026

Scope coverage

Class IIa3

3 scopes

Mały sterylizator parowy / Small steam steriliser
Class IIa
Enbio S
Class IIa
Enbio PRO
Class IIa

Documents

LanguagesENPL