Scitech Produtos Médicos SA

Certificate 2025-MDR/QS-016

Rev. 00Issued

Valid until: Feb 7, 2030

Certificate 2025-MDR/QS-016 is a valid Quality management system issued to Scitech Produtos Médicos SA and registered in EUDAMED. Valid until February 7, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: 2025-MDR/QS-016
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-01600

Validity

Issued: Feb 7, 2025
Valid from: Feb 7, 2025
Valid until: Feb 7, 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: No
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 III2

2 scopes

PTA BALLOON DILATATION CATHETERS
Class III
DEVICE
Class III

Documents

LanguagesEN