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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

aiSkin-DT — Class I MDR by AiScreenings

MD Atlas
AiScreenings

EUDAMED last updated this device on Aug 31, 2023

aiSkin-DT

3770032512aiSkin-DTXN

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: AiScreenings
UDI-DI code: 03770032512006
Reference / catalog number: 1.0.0

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Manufacturer information

Organization name: AiScreenings
SRN: FR-MF-000029216
Manufacturer status: Active

Market distribution

Primary placement in France; available across 1 country total.

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

Device identification

Trade name: aiSkin-DT
UDI-DI code: 03770032512006
Basic UDI-DI: 3770032512aiSkin-DTXN
Reference / catalog number: 1.0.0
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: aiSkin-DT is a support to diagnosis and monitoring software for dermatology
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0202059092VARIOUS PROCESSING INSTRUMENTS FOR HYSTOLOGY / CYTOLOGY - IVD MEDICAL DEVICE SOFTWARE

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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

aiVista-DT3770032512aiVista-DTHYOn the market

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.