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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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HELMED® Automated IFA Processor — 2 UDI-DI variants, IVDR

MD Atlas
Aesku.Diagnostics GmbH & Co. KG

Data from EUDAMED, last updated May 30, 2026

HELMED® Automated IFA Processor

42502895HELMEDFH

2 UDI-DI variants

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: Aesku.Diagnostics GmbH & Co. KG

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Device characteristics

Professional testing

Identity & classification

Basic UDI-DI: 42502895HELMEDFH
Device name: HELMED® Automated IFA Processor
Device model: 20110009
Issuing agency: GS1
Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class A
Version date: May 26, 2026

Manufacturer & authorised representative

Manufacturer

Name: Aesku.Diagnostics GmbH & Co. KG
SRN: DE-MF-000026925
Country: Germany
Email: registrations@aesku.com
Phone: +49673496220

Variants by status

UDI-DI variants

2 UDI-DI variants

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Export results

Applied filters

basicUdiUlid01KSHMHG879MXE8TBEB58J2ZH9

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

REF.HEL-100004250289512565
REF.HEL-800204250289512657