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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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Hitergent — 1 UDI-DI variant, IVDR (GIESSE DIAGNOSTICS SRL)

MD Atlas
GIESSE DIAGNOSTICS SRL

Data from EUDAMED, last updated May 30, 2026

Hitergent

805317297HIT0018L

1 UDI-DI variant

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]IVDR Class A

Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class A
Manufacturer: GIESSE DIAGNOSTICS SRL

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Device characteristics

Professional testing

Identity & classification

Basic UDI-DI: 805317297HIT0018L
Device name: Hitergent
Device model: 3939/4
Issuing agency: GS1
Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class A
Version date: Apr 14, 2026

Manufacturer & authorised representative

Manufacturer

Name: GIESSE DIAGNOSTICS SRL
SRN: IT-MF-000039031
Country: Italy
Email: info@giessediagnostics.com
Phone: +39 0774 051100

Variants by status

UDI-DI variants

1 UDI-DI variant

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Export results

Applied filters

basicUdiUlid01KP5HWC0H0D4XAZWW3D9Y6XDG

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

3939/408053172972530