Simeks Tibbi Urunler San. ve Tic LTD STI

Certificate M.2025.MDR.1088

Rev. 01Supplemented

Valid until: Nov 10, 2028

Certificate M.2025.MDR.1088 is a valid Quality management system issued to Simeks Tibbi Urunler San. ve Tic LTD STI and registered in EUDAMED. Valid until November 10, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: M.2025.MDR.1088
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 2696M.2025.MDR.108801

Validity

Issued: May 17, 2026
Valid from: May 17, 2026
Valid until: Nov 10, 2028

Notified body

Notified body: UDEM Adriatic d.o.o.
Notified body SRN: 2696
Notified body country: Croatia

Covered devices

No specific devices are listed for this certificate.

Characteristics

Sterile: Yes
Human tissues: No
Animal tissues: No
In vitro diagnostics: No
Initial registration: No
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: No
QMS/MOS type: Others

History

Status changes

Supplemented
Supplemented

Supersedes

M.2025.MDR.1088Quality management systemIssuedNov 11, 2025 → Nov 10, 2028

Scope coverage

Class III1

1 scope

Sterile Simpass PTCA Balloon Dilatation Catheter 1. 86993436PTCASC89-SIMPASS PLUS RX PTCA Balloon Dilatation Catheter 2. 86993436PTCANC7S-Simpass NC-HP RX PTCA Balloon Dilatation Catheter 3. 86993436PTCACTOEA-Simpass CTO RX PTCA Balloon Dilatation Catheter
Class III

Documents

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