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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

A001-007-v03 — Class I MDR by Oculox Technologies SA

MD Atlas
Oculox Technologies SA

EUDAMED last updated this device on May 15, 2026

A001-007-v03

76499881684RetinaWiseRL

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Oculox Technologies SA
UDI-DI code: 07649988168413
Reference / catalog number: A001-007-v03

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Manufacturer information

Organization name: Oculox Technologies SA
SRN: CH-MF-000038775
Manufacturer status: Active

Market distribution

Primary placement in Ireland; available across 1 country total.

Country	On market since	Until
IrelandPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 07649988168413
Basic UDI-DI: 76499881684RetinaWiseRL
Reference / catalog number: A001-007-v03
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: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Q0299OPHTHALMIC DEVICES - OTHER

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

Certificate health across this manufacturer's portfolio.

IT349481Issued
Quality management systemNotified body: 1370Expiry: Jan 29, 2030