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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

Ilert v10 — Class I MDR by Optolab 3DTechnologies…

MD Atlas
Optolab 3DTechnologies Limited

EUDAMED last updated this device on Feb 20, 2026

Ilert v10

539155185REFTH6

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Optolab 3DTechnologies Limited
UDI-DI code: 05391551850028
Reference / catalog number: Ilert v10

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Manufacturer information

Organization name: Optolab 3DTechnologies Limited
SRN: IE-MF-000051764
Manufacturer status: Active

Related devices

Ilert v10539155185BINOEQOn the market Ilert v10539155185CVTSHSOn the market Ilert v10539155185BASEDBOn 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 Ireland; available across 1 country total.

Placed on the market in Ireland; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: 05391551850028
Basic UDI-DI: 539155185REFTH6
Reference / catalog number: Ilert v10
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: Test for screening for the presence of refractive error
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z1212012092INSTRUMENTS FOR THE ASSESSMENT OF VISUAL FUNCTIONALITY - 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