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EUDAMED last updated this device on Jan 27, 2025
506071773DERM-DX-CEMDRXUDERM is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class III. Manufactured by Skin Analytics Ltd.. Placed on the EU market in Northern Ireland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
05060717730046DERM v4(01)05060717730046
European Medical Device Nomenclature — the EU product classification assigned to this device.
Z12040192GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE1 warning recorded — scroll inside the panel to see all entries.
DERM should not be used on: ● Patients under the age of 18 ● Assessing skin conditions where the concern is not of skin cancer (e.g. rashes, eczema, infectious diseases, lupus) ● Monitoring treatment ● Staging of disease ● Images other than dermoscopic images of skin lesions ● Images of skin lesions from a subject other than the identified patient ● Open or ulcerated skin lesions ● Skin lesions unable to be entirely imaged within the dermoscopic device used ● Skin lesions obscured by hair, tattoos or scars ● Skin lesions beneath nails, in eyes or on mucosal surfaces or on soles of feet or palms of hands ● Skin lesions which have previously been biopsied
Primary placement in XI; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| XIPrimary placement | — | Still on market |
GB-MF-000017972SCAR-2.2.1.4SCAR-2.3.1.4The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
View in glossary →Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
View in glossary →Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
View in glossary →CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
View in glossary →Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
View in glossary →UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
View in glossary →MDR risk classes
MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Certificate health across this manufacturer's portfolio.
SCAR-2.3.1.4SupplementedSCAR-2.2.1.4SupplementedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
View in glossary →Notified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
View in glossary →