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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

Autoderm 2.0 — Class I MDD by iDoc24 AB

MD Atlas
iDoc24 AB

EUDAMED last updated this device on Oct 31, 2022

Autoderm 2.0

B-04262385680024

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: iDoc24 AB
UDI-DI code: 04262385680024
Reference / catalog number: Autoderm 2.0

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Manufacturer information

Organization name: iDoc24 AB
SRN: SE-MF-000021836
Manufacturer status: Active

Related devices

This device is not currently linked to any other device.

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW133
To be used as a search engine on good quality pictures taken with a smartphone of dermatology concerns. It is not a diagnostic software, but a decsion support tool to guide the end user on dermatology concerns.

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Market distribution

Primary placement in Sweden; available across 2 countries total.

Country	On market since	Until
SwedenPrimary placement	Jan 1, 2019	Still on market
Spain	Jan 1, 2019	Still on market

Device identification

Trade name: not provided
UDI-DI code: 04262385680024
Basic UDI-DI: B-04262385680024
Reference / catalog number: Autoderm 2.0
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Dermatology search engine using artifical intelligence
Additional information URL: https://www.firstderm.com/autoderm-dermatology-artificial-intelligence-ai-api/
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)04262385680024

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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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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.