Alvimedica Tibbi Urunler San. ve Dis Tic. A.S.

Certificate 0425-MDR-006771-00

Rev. 00Issued

Valid until: Jul 3, 2028

Certificate 0425-MDR-006771-00 is a valid Quality management system issued to Alvimedica Tibbi Urunler San. ve Dis Tic. A.S. and registered in EUDAMED. Valid until July 3, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: 0425-MDR-006771-00
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 04250425-MDR-006771-0000

Validity

Issued: Jul 4, 2023
Valid from: Jul 4, 2023
Valid until: Jul 3, 2028

Manufacturer

Manufacturer: Alvimedica Tibbi Urunler San. ve Dis Tic. A.S.
Manufacturer SRN: TR-MF-000029915
Manufacturer country: Türkiye

Notified body

Notified body
Notified body SRN: 0425
Notified body country: Italy

Covered devices

Alvision Interventional Cardiology Diagnostic CatheterClass III
086991955Alvision5D

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

History

No status changes or preceding certificates are recorded.

Scope coverage

Class III2

2 scopes

Alvision Interventional Cardiology diagnostic catheter
Class III
DEVICE
Class III

Documents

LanguagesEN