Simeks Tibbi Urunler San. ve Tic LTD STI

Certificate M.2025.MDR.2020

Rev. 01Supplemented

Valid until: Nov 10, 2028

Certificate M.2025.MDR.2020 is a valid Technical documentation 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.2020
Certificate type: Technical documentation
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 2696M.2025.MDR.202001

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

Characteristics

Sterile: —
Human tissues: —
Animal tissues: —
In vitro diagnostics: —
Initial registration: No
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: No
Intended medical purpose: —
SPP applicable: —
Conditions applicable: No
MOS outside EUDAMED: No
QMS/MOS type: Others

History

Status changes

Supplemented

Supersedes

M.2025.MDR.1088-1Technical documentationIssuedNov 11, 2025 → Nov 10, 2028

Scope coverage

Unspecified3

3 scopes

Simpass Plus RX PTCA Balloon Dilatation Catheter
86993436PTCASC89
Simpass NC HP RX PTCA Balloon Dilatation Catheter
86993436PTCANC7S
Simpass CTO RX PTCA Balloon Dilatation Catheter
86993436PTCACTOEA

Documents

LanguagesEN