Skin Analytics Ltd.

Certificate SCAR-2.2.1.4

Supplemented

Valid until: Dec 18, 2029

Certificate SCAR-2.2.1.4 is a valid Quality management system issued to Skin Analytics Ltd. and registered in EUDAMED. Valid until December 18, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: SCAR-2.2.1.4
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 3022SCAR-2.2.1.4

Validity

Issued: Jun 10, 2026
Valid from: Jun 10, 2026
Valid until: Dec 18, 2029

Manufacturer

Manufacturer: Skin Analytics Ltd.
Manufacturer SRN: GB-MF-000017972
Manufacturer country: United Kingdom

Notified body

Notified body
Notified body SRN: 3022
Notified body country: Netherlands

Covered devices

DERMClass III
506071773DERM-DX-CEMDRXU

Characteristics

Sterile: No
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

Status changes

Supplemented

Supersedes

SCAR-2.2.1.3AmendedMay 26, 2026 → Dec 18, 2029

Predecessor certificate not registered in EUDAMED.

Scope coverage

Class III2

2 scopes

Device Category: MDA 0315 - Software Generic Device Group: Z120401 - General medicine diagnosis and monitoring instruments Device Name: Deep Ensemble for Recognition of Malignancy (DERM)
Class III
DEVICE
Class III

Documents

LanguagesEN