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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

IXS-SWL-nn — Class I MDR by Ergotrics

MD Atlas
Ergotrics

EUDAMED last updated this device on Aug 21, 2025

IXS-SWL-nn

5430001965IXSZT

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Ergotrics
UDI-DI code: 05430001965353
Reference / catalog number: IXS-SWL-nn

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Manufacturer information

Organization name: Ergotrics
SRN: BE-MF-000024176
Manufacturer status: Active

Market distribution

Primary placement in Belgium; available across 1 country total.

Country	On market since	Until
BelgiumPrimary placement		Still on market

Device identification

Trade name: IXS-SWL-nn
UDI-DI code: 05430001965353
Basic UDI-DI: 5430001965IXSZT
Reference / catalog number: IXS-SWL-nn
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: Inflatable patient support for multiple applications
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12011285PATIENT POSITIONING INSTRUMENTS - CONSUMABLES

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

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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.