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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

ADAS 3D — Class IIa MDD by ADAS3D MEDICAL, S.L.

MD Atlas
ADAS3D MEDICAL, S.L.

EUDAMED last updated this device on Oct 29, 2021

ADAS 3D

B-08437021722017

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: ADAS3D MEDICAL, S.L.
UDI-DI code: 08437021722017
Reference / catalog number: ADAS 3D

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Manufacturer information

Organization name: ADAS3D MEDICAL, S.L.
SRN: ES-MF-000000391
Manufacturer status: Active

Market distribution

Primary placement in Spain; available across 1 country total.

Country	On market since	Until
SpainPrimary placement	Apr 7, 2020	Mar 8, 2022

Device identification

Trade name: not provided
UDI-DI code: 08437021722017
Basic UDI-DI: B-08437021722017
Reference / catalog number: ADAS 3D
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: A software intended to be used for the visualization and analysis of enhancement in MR and CT cardiovascular images on patients with cardiovascular disease
Additional information URL: https://www.adas3d.com/en/ifu.html
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z11039082VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - SOFTWARE ACCESSORIES

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

ADAS 3D ver. 2.138437021722ADAS3DWXOn the market ADAS 3D ver. 2.118437021722ADAS3DWXOn the market ADAS 3D ver. 2.128437021722ADAS3DWXOn the market ADAS 3D ver. 2.98437021722ADAS3DWXOn 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.