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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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immuClone (1) Anti-K IgM and Galileo — 3 UDI-DI variants, IVDR

MD Atlas
IMMUCOR Medizinische Diagnostik GmbH

Data from EUDAMED, last updated May 23, 2026

immuClone (1) Anti-K IgM and Galileo

88823405W0103030501D26KK

3 UDI-DI variants

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

Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class D
Manufacturer: IMMUCOR Medizinische Diagnostik GmbH

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Device characteristics

ReagentProfessional testingHuman tissues / cellsAnimal tissues / cells

Legacy certificates

Certificate number: IX 1191616-12
Type: refdata.certificate-ivdr-type.technical-documentation
Notified body: TÜV Rheinland LGA Products GmbH (0197)
Validity: Nov 22, 2023 → Nov 21, 2028

Identity & classification

Basic UDI-DI: 88823405W0103030501D26KK
Device name: immuClone (1) Anti-K IgM and Galileo
Issuing agency: GS1
Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class D
Version date: Dec 18, 2023

Manufacturer & authorised representative

Manufacturer

Name: IMMUCOR Medizinische Diagnostik GmbH
SRN: DE-MF-000006494
Country: Germany
Email: germany@immucor.com
Phone: +49 6103 8056 0

Variants by status

UDI-DI variants

3 UDI-DI variants

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Applied filters

basicUdiUlid01HHYJP9PMG4D38VKXFNEM46KC

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

006602010888234301011
000801610888234300625
000802610888234300632