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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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Gram-Polychrome JetDye-AF Kit — 2 UDI-DI variants, IVDR

MD Atlas
Bio-Gram Diagnostics GmbH

Data from EUDAMED, last updated May 23, 2026

Gram-Polychrome JetDye-AF Kit

426240002GPJetDye3Y

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: Bio-Gram Diagnostics GmbH

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Device characteristics

ReagentProfessional testing

Identity & classification

Basic UDI-DI: 426240002GPJetDye3Y
Device name: Gram-Polychrome JetDye-AF Kit
Issuing agency: GS1
Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class A
Version date: Mar 2, 2026

Manufacturer & authorised representative

Manufacturer

Name: Bio-Gram Diagnostics GmbH
SRN: DE-MF-000032559
Country: Germany
Email: contact@bio-gram.de
Phone: +49 621 490 844 50

Variants by status

UDI-DI variants

2 UDI-DI variants

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Export results

Applied filters

basicUdiUlid01KJQATJ8JZFJWHY9CHS5FDDAH

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

Gram-Polychrome JetDye-AF Kit04262400020132
SK220920104262400022013