Enbio Group AG

Certificate TNP/MDR/0037/4780/2025

Rev. Ver. 02Issued

Valid until: Jun 15, 2028

Certificate TNP/MDR/0037/4780/2025 is a valid Quality management system issued to Enbio Group AG and registered in EUDAMED. Valid until June 15, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: TNP/MDR/0037/4780/2025
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 2274TNP/MDR/0037/4780/2025Ver. 02

Validity

Issued: Jun 16, 2025
Valid from: Jun 16, 2025
Valid until: Jun 15, 2028

Manufacturer

Manufacturer: Enbio Group AG
Manufacturer SRN: CH-MF-000054967
Manufacturer country: Switzerland

Notified body

Notified body
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: Yes
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: No
Intended medical purpose: No
SPP applicable

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIa3

3 scopes

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

Documents

LanguagesENPL