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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

Phyxiom — Class I MDR by Phyxiom Limited

MD Atlas
Phyxiom Limited

EUDAMED last updated this device on May 25, 2026

Phyxiom

539155293PHYX-CDS-00252

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Phyxiom Limited
UDI-DI code: 53915529300024
Reference / catalog number: PHYX-CDS-002

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View device family (Basic UDI)

Manufacturer information

Organization name: Phyxiom Limited
SRN: IE-MF-000054005
Manufacturer status: Active

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Ireland; available across 1 country total.

Country	On market since	Until
IrelandPrimary placement	Jan 1, 2025	Still on market

Device identification

Trade name: Phyxiom
UDI-DI code: 53915529300024
Basic UDI-DI: 539155293PHYX-CDS-00252
Reference / catalog number: PHYX-CDS-002
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: Web-based clinical decision support platform for respiratory clinicians managing asthma and COPD patients in outpatient settings
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)53915529300024

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

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

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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.

Related devices

This device is not currently linked to any other device.