Aidence B.V.

Certificate SCAR-15.2.1.1

Amended

Valid until: Oct 1, 2030

Certificate SCAR-15.2.1.1 is a valid Quality management system issued to Aidence B.V. and registered in EUDAMED. Valid until October 1, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: SCAR-15.2.1.1
Certificate type: Quality management system
Certificate status: Amended
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 3022SCAR-15.2.1.1

Validity

Issued: May 26, 2026
Valid from: May 26, 2026
Valid until: Oct 1, 2030

Notified body

Notified body: Scarlet NB B.V.
Notified body SRN: 3022
Notified body country: Netherlands

Characteristics

Sterile: No
Human tissues: No
Animal tissues: No
In vitro diagnostics: No
Initial registration: Yes
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: Basic UDI-DI data and Class IIb

History

Status changes

Amended

Supersedes

SCAR-15.2.1.0IssuedFeb 15, 2026 → Oct 1, 2030

Predecessor certificate not registered in EUDAMED.

Scope coverage

Class IIb2

2 scopes

MDA 0315 Z110690 - Various Digital Bioimaging Management Instruments
Class IIb
DEVICE
Class IIb

Documents

LanguagesEN