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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

iAST — Class IIa MDR by Pragmatech AI Solutions

MD Atlas
Pragmatech AI Solutions

EUDAMED last updated this device on Jan 22, 2026

iAST

8437026644IAST74

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Pragmatech AI Solutions
UDI-DI code: 08437026644000
Reference / catalog number: iAST

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Manufacturer information

Organization name: Pragmatech AI Solutions
SRN: ES-MF-000039516
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: not provided
UDI-DI code: 08437026644000
Basic UDI-DI: 8437026644IAST74
Reference / catalog number: iAST
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: iAST® es una herramienta software que tiene como objeto asistir al médico en la prescripción de antibióticos, prediciendo de forma precisa la sensibilidad a los antibióticos más frecuentes antes de conocer los resultados microbiológicos definitivos (identificación bacteriana y antibiograma).
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12040292GENERAL MEDICINE THERAPEUTIC TREATMENT 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.