Derm

Ref DERM v5Model Deep Ensemble for Recognition of Malignancy (DERM) V4

Withdrawn Withdrawn in European Union. No longer placed on the EU market.

Was authorized under CE MDR

Ended

Withdrawn

Date not published (CE MDR)

FDA recalls

Not applicable

No FDA record for this device

Documents

Certifier Scarlet NB B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	NumberSCAR-2.2.1.4	Date10 Jun 2026Issued	StatusWithdrawn No longer placed on the EU market expires 18 Dec 2029
European Union	CE/MDR	NumberSCAR-2.3.1.4	Date10 Jun 2026Issued	StatusWithdrawn No longer placed on the EU market expires 18 Dec 2029
European Union	CE/MDR	Number506071773DERM-DX-CEMDRXU Basic UDI-DI 05060717730077UDI-DI	Date27 Jan 2025Registered	StatusWithdrawn No longer placed on the EU market

2 certificates · EUDAMED

1 jurisdiction

European Union — CE/MDR Withdrawn

EUDAMED

Model / Reference: Deep Ensemble for Recognition of Malignancy (DERM) V4, DERM v5

Primary DI / UDI-DI: 05060717730077
Basic UDI-DI: 506071773DERM-DX-CEMDRXU
EMDN Code: Z12040192 General medicine diagnosis and monitoring instruments - medical device software