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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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Helicobacter pylori IgA ELISA — 1 UDI-DI variant, IVDD

MD Atlas
IBL International GmbH

Data from EUDAMED, last updated May 30, 2026

Helicobacter pylori IgA ELISA

B-04049325002340

1 UDI-DI variant

IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]IVDD — General

Legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Risk class: IVDD — General
Manufacturer: IBL International GmbH

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Device characteristics

ReagentProfessional testingHuman tissues / cellsAnimal tissues / cells

Identity & classification

Basic UDI-DI: B-04049325002340
Device name: Helicobacter pylori IgA ELISA
Issuing agency: EUDAMED
Legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Risk class: IVDD — General
Version date: May 27, 2026

Manufacturer & authorised representative

Manufacturer

Name: IBL International GmbH
SRN: DE-MF-000015709
Country: Germany
Email: IBL@tecan.com
Phone: + 49 40 5328910

Variants by status

UDI-DI variants

1 UDI-DI variant

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Applied filters

basicUdiUlid01KSMAEV4BBVYSK029TKE0CN7M

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

RE5637104049325002340