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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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IRILENS GOCCE OCULARI — 1 UDI-DI variant, MDD (MONTEFARMACO OTC SPA)

MD Atlas
MONTEFARMACO OTC SPA

Data from EUDAMED, last updated May 30, 2026

IRILENS GOCCE OCULARI

B-IRILENSA3

1 UDI-DI variant

MDD [Directive 93/42/EEC on medical devices]Class IIb

Legislation: MDD [Directive 93/42/EEC on medical devices]
Risk class: Class IIb
Manufacturer: MONTEFARMACO OTC SPA

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Device characteristics

No device characteristics flagged

Legacy certificates

Certificate number: 2019/MDD
Type: refdata.legacy.mdd-certificate-type.ii-excluding-4
Notified body: IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A. (0051)
Validity: May 26, 2024

Identity & classification

Basic UDI-DI: B-IRILENSA3
Device name: IRILENS GOCCE OCULARI
Device model: IRILENS MONODOSE
Issuing agency: EUDAMED
Legislation: MDD [Directive 93/42/EEC on medical devices]
Risk class: Class IIb
Version date: May 9, 2022

Manufacturer & authorised representative

Manufacturer

Name: MONTEFARMACO OTC SPA
SRN: IT-MF-000013309
Country: Italy
Email: regolatorio@montefarmaco.it

Variants by status

UDI-DI variants

1 UDI-DI variant

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Applied filters

basicUdiUlid01G2MNMN4Q8YP054KRP64ND4K0

Format

Summary

29 columns included

Trade name
Basic UDI-DI
UDI-DI code
Risk category
Applicable legislation
Status
Organization name
SRN
Reference / catalog number
Additional product description
Intended medical purpose
Placed on the market (country)
Market info update date
Sterile
Single use
Contains latex
Reprocessed single-use
Direct marking
CMR substance
Endocrine disruptor
Annex XVI applicable
Sterilization
OEM applicable
EMDN codes
Last updated
Basic UDI-DI device name
Basic UDI-DI device model
Basic UDI-DI implantable
Basic UDI-DI reagent

01675D-IRILENSA3