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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 Innodrops F1a — 16 UDI-DI variants, MDR

MD Atlas
ENABLE INNOVATIONS SRL

Data from EUDAMED, last updated May 31, 2026

Gocce oculari Innodrops F1a

80540851201NH

16 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-030020-01
Type: refdata.certificate-mdr-type.quality-management-system
Notified body: ICIM S.P.A. (0425)
Validity: Mar 26, 2025 → Feb 26, 2028

Identity & classification

Basic UDI-DI: 80540851201NH
Device name: Gocce oculari Innodrops F1a
Device model: Gocce oculari Innodrops F1a
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIb
Version date: Apr 20, 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

16 UDI-DI variants

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Applied filters

basicUdiUlid01KPNF1967PNAS6HB37CJ1ZFTF

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

05057308054085122173
05057408054085122180
Contact care drops (GOF1aM-004)08054085121176
Crystalline blue gocce oculari (GOF1aM-002)08054085120384
Eyerelax (GOF1aP-004)08054085120513
05012808054085120391
Healthcare (GOF1aP-003)05400606945722
Novadrops (GOF1aP-008)08054085120520
05019308054085120407
05032408054085120834
05048208054085121794
05020108054085120544
05020208054085120551
Visustrin gocce oculari (GOF1aM-007)08054085120599
05039908054085121343
05040508054085121350