Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

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

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

Legit.Health — Class I MDD by AI LABS GROUP, S.L.

MD Atlas
AI LABS GROUP, S.L.

EUDAMED last updated this device on Jan 13, 2024

Legit.Health

B-Legit.Health8U

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: AI LABS GROUP, S.L.
UDI-DI code: D-Legit.Health8U
Reference / catalog number: Legit.Health

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

Organization name: AI LABS GROUP, S.L.
SRN: ES-MF-000025345
Manufacturer status: Active

Critical warnings

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

CW010
In case of observing an incorrect operation of the software, notify the manufacturer as soon as possible: support@ legit.health. The manufacturer will proceed accordingly. Any serious incident should be reported to AI Labs Group S.L. as well as to the National Competent Authority of the country.

Market distribution

Primary placement in Spain; available across 1 country total.

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

Device identification

Trade name: Legit.Health
UDI-DI code: D-Legit.Health8U
Basic UDI-DI: B-Legit.Health8U
Reference / catalog number: Legit.Health
Issuing entity: EUDAMED

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: The intended purpose is to support doctors during the diagnostic process, thanks to the medical information provided by the device as a result of image processing and analysis. This process contributes indirectly to a faster, more efficient and cost-effective diagnosis, and to a more continuous and objective monitoring of the severity of the disease, especially with regard to telemedicine.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12040192GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - 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

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.