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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

BIAlert — Class IIa MDR by ASOCIACIÓN PARA EL…

MD Atlas
ASOCIACIÓN PARA EL DESARROLLO DE LA INGENIERÍA DEL CONOCIMIENTO (ADIC)

EUDAMED last updated this device on May 6, 2026

BIAlert

8437026010BIALERT86

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: ASOCIACIÓN PARA EL DESARROLLO DE LA INGENIERÍA DEL CONOCIMIENTO (ADIC)
UDI-DI code: 00084370260103
Reference / catalog number: BIAlert

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Manufacturer information

Organization name: ASOCIACIÓN PARA EL DESARROLLO DE LA INGENIERÍA DEL CONOCIMIENTO (ADIC)
SRN: ES-MF-000035725
Manufacturer status: Active

Critical warnings

4 warnings recorded — scroll inside the panel to see all entries.

CW023
Monitor the operation of the software if you are near a source of electromagnetic interference. Electromagnetic interference can affect the operation of electronic equipment
CW999
BIAlert® is not an automatic diagnostic tool but rather a support tool for the medical professional in the form of alarms, which help them identify possible sepsis or septic shock early. The alert does not constitute a diagnosis in itself, which must always be carried out by the medical professional in charge of the patient. BIAlert® provides information for early automated detection, but it is not a diagnosis itself. No action should be taken regarding the patient without the decision of a medical professional.
CW011
BIALERT® is not intended to replace in any way the clinical decision of a medical professional, but to provide information obtained through artificial intelligence tools,big dataand Machine Learningthat can be a support in the early detection of these clinical conditions.
CW010
Do not use the BIALERT® if you have not been trained to do so.

Market distribution

Primary placement in Spain; available across 1 country total.

Country	On market since	Until
SpainPrimary placement	May 29, 2024	Still on market

Device identification

Trade name: not provided
UDI-DI code: 00084370260103
Basic UDI-DI: 8437026010BIALERT86
Reference / catalog number: BIAlert
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: BIAlert is a medical device software intended to be used as a tool for early prediction of sepsis and septic shock disease.
Additional information URL: https://www.iic.uam.com/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

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

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.