Simeks Tibbi Urunler San. ve Tic LTD STI

Certificate M.2025.MDR.1089

Rev. 00Withdrawn

Valid until: Nov 10, 2030

Certificate M.2025.MDR.1089, a Quality management system issued to Simeks Tibbi Urunler San. ve Tic LTD STI, has been withdrawn. View the full certificate record on MD Atlas.

Overview

Certificate number: M.2025.MDR.1089
Certificate type: Quality management system
Certificate status: Withdrawn
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 2696M.2025.MDR.108900

Validity

Issued: Nov 11, 2025
Valid from: Nov 11, 2025
Valid until: Nov 10, 2030

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: Yes
Mechanism of scrutiny: No
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Others

History

Status changes

Withdrawn

Supersedes

M.2025.MDR.1089Quality management systemIssuedNov 11, 2025 → Nov 10, 2030

Scope coverage

Class IIa1

1 scope

Sterile,Simpass Endo PTA Balloon Dilatation Catheter
Class IIa

Documents

LanguagesEN