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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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GHOTO — 4 UDI-DI variants, MDR (Alker medicale S.r.l.)

MD Atlas
Alker medicale S.r.l.

Data from EUDAMED, last updated May 30, 2026

GHOTO

805127754HALKF8T

4 UDI-DI variants

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

Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class I
Manufacturer: Alker medicale S.r.l.

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Device characteristics

No device characteristics flagged

Identity & classification

Basic UDI-DI: 805127754HALKF8T
Device name: GHOTO
Device model: HALKF
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class I
Version date: Nov 28, 2022

Manufacturer & authorised representative

Manufacturer

Name: Alker medicale S.r.l.
SRN: IT-MF-000030943
Country: Italy
Email: info@alker.it
Phone: +390498809426

Variants by status

UDI-DI variants

4 UDI-DI variants

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Export results

Applied filters

basicUdiUlid01GJYGZT1YVQFBANVCTC2BJS1G

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

HALKF047V08051277540470
HALKF051V08051277540517
HALKF052V08051277540524
HALKF50V08051277540500