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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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Gocce oculari 0,4% HA — 2 UDI-DI variants, MDR

MD Atlas
ENABLE INNOVATIONS SRL

Data from EUDAMED, last updated May 31, 2026

Gocce oculari 0,4% HA

80540851217NY

2 UDI-DI variants

MDR [Regulation (EU) 2017/745 on medical devices]Class IIb

Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIb
Manufacturer: ENABLE INNOVATIONS SRL

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Device characteristics

No device characteristics flagged

Legacy certificates

Certificate number: 0425-MDR-030119-01
Type: refdata.certificate-mdr-type.quality-management-system
Notified body: ICIM S.P.A. (0425)
Validity: Feb 25, 2026 → Feb 2, 2030

Identity & classification

Basic UDI-DI: 80540851217NY
Device name: Gocce oculari 0,4% HA
Device model: Gocce oculari 0,4% HA
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIb
Version date: Apr 14, 2026

Manufacturer & authorised representative

Manufacturer

Name: ENABLE INNOVATIONS SRL
SRN: IT-MF-000026066
Country: Italy
Email: info@enableinnovations.it
Phone: +39 0596550010

Variants by status

UDI-DI variants

2 UDI-DI variants

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Applied filters

basicUdiUlid01KP60S6P5F6AW8TJA5Z02XBKT

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

05059808054085122296
05057808054085122203