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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

Skinive — Class I MDR by Skinive LTD.

MD Atlas
Skinive LTD.

EUDAMED last updated this device on Oct 9, 2025

Skinive

535666000072SKINIVE001S8

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Skinive LTD.
UDI-DI code: 05356660000726
Reference / catalog number: V1.2.0

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View device family (Basic UDI)

Manufacturer information

Organization name: Skinive LTD.
SRN: MT-MF-000047900
Manufacturer status: Active

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Netherlands; available across 1 country total.

Placed on the market in Netherlands; per-country availability dates not published.

Device identification

Trade name: Skinive
UDI-DI code: 05356660000726
Basic UDI-DI: 535666000072SKINIVE001S8
Reference / catalog number: V1.2.0
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Skinive is a suite of AI-powered software medical devices (SaMD) for skin health monitoring and risk assesment. The product line includes: Skinive App for adult users to document and track skin changes; Skinive MD for healthcare professionals supporting AI-assisted lesion analysis and patient management; and Skinive API, enabling integration of anonymized AI skin assessment into third-party medical systems. MDR Class I, GDPR compliant.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)05356660000726

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

V92MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

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Related devices

This device is not currently linked to any other device.

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.