Aqvitox Technology, s.r.o.

Certificate 2024-MDR/QS-012/A

Rev. 01Supplemented

Valid until: Mar 20, 2029

Certificate 2024-MDR/QS-012/A is a valid Quality management system issued to Aqvitox Technology, s.r.o. and registered in EUDAMED. Valid until March 20, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: 2024-MDR/QS-012/A
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 22652024-MDR/QS-012/A01

Validity

Issued: Jul 16, 2025
Valid from: Jul 16, 2025
Valid until: Mar 20, 2029

Notified body

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

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: Yes
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Basic UDI-DI data and Class IIb

History

Status changes

Supplemented

Supersedes

2024-MDR/QS-012IssuedMar 20, 2024 → Mar 20, 2029

Predecessor certificate not registered in EUDAMED.

Scope coverage

Class IIb3

3 scopes

Dressings in solutions, emulsions, gels, powders with synthetic components
Class IIb
DEVICE
Class IIb
DEVICE
Class IIb