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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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Histamine ELISA — 1 UDI-DI variant, IVDR (IBL International GmbH)

MD Atlas
IBL International GmbH

Data from EUDAMED, last updated May 23, 2026

Histamine ELISA

4049325IVR06030000BRB

1 UDI-DI variant

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

Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class B
Manufacturer: IBL International GmbH

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Device characteristics

ReagentProfessional testingAnimal tissues / cells

Identity & classification

Basic UDI-DI: 4049325IVR06030000BRB
Device name: Histamine ELISA
Issuing agency: GS1
Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class B
Version date: Apr 19, 2024

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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Export results

Applied filters

basicUdiUlid01HVV0MGV6PJPJY6NH187FDDGT

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

RE5922104049325033177