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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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2-ME solution for the differrentiation… — 1 UDI-DI variant, IVDR

MD Atlas
Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach

Data from EUDAMED, last updated May 30, 2026

2-ME solution for the differrentiation of IgM and IgG antibodies

5904365620MEH4

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: Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach

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Device characteristics

ReagentProfessional testing

Identity & classification

Basic UDI-DI: 5904365620MEH4
Device name: 2-ME solution for the differrentiation of IgM and IgG antibodies
Issuing agency: GS1
Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class A
Version date: Feb 12, 2024

Manufacturer & authorised representative

Manufacturer

Name: Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach
SRN: PL-MF-000037642
Country: Poland
Email: dpos@rckik-katowice.pl
Phone: +48 322087408

Variants by status

UDI-DI variants

1 UDI-DI variant

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basicUdiUlid01HG00WKQJBJ543Z7MSM8QGW70

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

2-ME solution for the differrentiation of IgM and IgG antibodies05904365620321