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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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GEL AFTE-LESIONI ORALI — 1 UDI-DI variant, MDD (Labomar S.p.A.)

MD Atlas
Labomar S.p.A.

Data from EUDAMED, last updated May 30, 2026

GEL AFTE-LESIONI ORALI

B-FTP040EH

1 UDI-DI variant

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

Legislation: MDD [Directive 93/42/EEC on medical devices]
Risk class: Class IIa
Manufacturer: Labomar S.p.A.

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UDI-DI variants

1 UDI-DI variant

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Applied filters

basicUdiUlid01HESKC1SFYD2WJ0E3GABBR6TJ

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

URGO Gel Aphtes Junior 8 ml FRD-FTP040EH

Device characteristics

No device characteristics flagged

Legacy certificates

Certificate number: EPT 0477.MDD.20/4094
Type: refdata.legacy.mdd-certificate-type.ii-excluding-4
Notified body: Eurofins Product Testing Italy S.r.l. (0477)
Validity: Jan 31, 2024

Identity & classification

Basic UDI-DI: B-FTP040EH
Device name: GEL AFTE-LESIONI ORALI
Issuing agency: EUDAMED
Legislation: MDD [Directive 93/42/EEC on medical devices]
Risk class: Class IIa
Version date: Nov 9, 2023

Manufacturer & authorised representative

Manufacturer

Name: Labomar S.p.A.
SRN: IT-MF-000007965
Country: Italy
Email: regulatoryMD@labomar.com
Phone: +3904227312

Variants by status