Axess Vision Technology

Certificate FR25/00000104

Rev. 2Supplemented

Valid until: Apr 29, 2030

Certificate FR25/00000104 is a valid Quality management system issued to Axess Vision Technology and registered in EUDAMED. Valid until April 29, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: FR25/00000104
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 1639FR25/000001042

Validity

Issued: May 28, 2025
Valid from: May 28, 2025
Valid until: Apr 29, 2030

Notified body

Notified body: SGS Belgium NV
Notified body SRN: 1639
Notified body country: Belgium

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: —
QMS/MOS type: Others

History

Status changes

Supplemented

Supersedes

FR25/00000104Quality management systemIssuedApr 29, 2025 → Apr 29, 2030

Scope coverage

Class I3

3 scopes

MDS1005
Class I
Cystoflex TM sterile single-use cystoscope
Class I
BroncoflexTM sterile single-use bronchoscope
Class I

Documents

LanguagesEN