BISMED, s.r.o.

Certificate 2025-MDR/QS-024/A

Rev. 01Issued

Valid until: Mar 25, 2030

Certificate 2025-MDR/QS-024/A is a valid Quality management system issued to BISMED, s.r.o. and registered in EUDAMED. Valid until March 25, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: 2025-MDR/QS-024/A
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 22652025-MDR/QS-024/A01

Validity

Issued: Mar 3, 2026
Valid from: Mar 3, 2026
Valid until: Mar 25, 2030

Notified body

Notified body: 3EC International a.s.
Notified body SRN: 2265
Notified body country: Slovakia

Characteristics

Sterile: Yes
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: Basic UDI-DI data only

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIa2

2 scopes

Drainage systems with redon type rigid container
Class IIa
DEVICE
Class IIa