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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

021 — Class IIa MDR by OPTILAB S.R.L.

MD Atlas
OPTILAB S.R.L.

EUDAMED last updated this device on May 12, 2026

021

805750736A02FX

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: OPTILAB S.R.L.
UDI-DI code: 08057507360429
Reference / catalog number: 021

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View device family (Basic UDI)

Manufacturer information

Organization name: OPTILAB S.R.L.
SRN: IT-MF-000026824
Manufacturer status: Active

Related devices

023805750736A02FXOn the market 025805750736A02FXOn the market 021805750736A02FXOn the market 023805750736A02FXOn the market 025805750736A02FXOn the market

Certificates

Certificate health across this manufacturer's portfolio.

066/MDRIssued
Quality assuranceNotified body: 0051Expiry: Dec 20, 2027

Critical warnings

2 warnings recorded — scroll inside the panel to see all entries.

CW010
Bugiardino per lente a contatto annuale idrofila
CW030
seguire sempre le istruzioni dello specialista di settore.

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Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement	Dec 21, 2022	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08057507360429
Basic UDI-DI: 805750736A02FX
Reference / catalog number: 021
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: lente a contatto morbida annuale bio gel sferica 58% idrofilia.
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)08057507360429

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

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

Q0210040102CONTACT LENSES - HYDROGEL, REUSABLE

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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