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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

IMR-DHX-nn — Class I MDR by Ergotrics

MD Atlas
Ergotrics

EUDAMED last updated this device on Aug 21, 2025

IMR-DHX-nn

5430001965IMRYQ

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Ergotrics
UDI-DI code: 05430001965605
Reference / catalog number: IMR-DHX-01

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Manufacturer information

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

Related devices

COV-PAU-nn5430001965COVY8On the market HMB-AAA-nn5430001965HMBXKOn the market HMB-DAA-nn5430001965HMBXKOn the market IBO-EOL-nn5430001965IBOXHOn the market IMC-HLD-nn5430001965IMCXSOn the market

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.

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: IMR-DHX-nn
UDI-DI code: 05430001965605
Basic UDI-DI: 5430001965IMRYQ
Reference / catalog number: IMR-DHX-01
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: DuoRoll
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12011280PATIENT POSITIONING INSTRUMENTS - HARDWARE ACCESSORIES

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

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Software identification