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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

acceXible — Class IIa MDR by AcceXible Impacto SL

MD Atlas
AcceXible Impacto SL

EUDAMED last updated this device on Feb 18, 2022

acceXible

8437023391ACXN3D

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: AcceXible Impacto SL
UDI-DI code: 08437023391006
Reference / catalog number: PR-0001-1.0.0-07/2020

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Manufacturer information

Organization name: AcceXible Impacto SL
SRN: ES-MF-000004596
Manufacturer status: Active

Market distribution

Primary placement in Spain; available across 1 country total.

Country	On market since	Until
SpainPrimary placement		Still on market

Device identification

Trade name: acceXible
UDI-DI code: 08437023391006
Basic UDI-DI: 8437023391ACXN3D
Reference / catalog number: PR-0001-1.0.0-07/2020
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: Speech analysis to detect and monitor mild cognitive impairment and dementia
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z1399NON-SPECIFIC CONSUMABLES FOR DIAGNOSTIC INSTRUMENTS - OTHER

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.