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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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IRMA MUC-1 gene associated antigen (CA… — 2 UDI-DI variants, IVDR

MD Atlas
IMMUNOTECH s.r.o.

Data from EUDAMED, last updated May 23, 2026

IRMA MUC-1 gene associated antigen (CA 15-3)

150995905CA15-3IRMAMG

2 UDI-DI variants

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

Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class C
Manufacturer: IMMUNOTECH s.r.o.

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Device characteristics

ReagentProfessional testing

Identity & classification

Basic UDI-DI: 150995905CA15-3IRMAMG
Device name: IRMA MUC-1 gene associated antigen (CA 15-3)
Device model: IM2397, B64314
Issuing agency: GS1
Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class C
Version date: Oct 1, 2025

Manufacturer & authorised representative

Manufacturer

Name: IMMUNOTECH s.r.o.
SRN: CZ-MF-000001761
Country: Czechia
Email: QACZ@beckman.com
Phone: +(420) 272 017 444

Variants by status

UDI-DI variants

2 UDI-DI variants

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Applied filters

basicUdiUlid01K6FTM91N7M7A999ZMCK267JE

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

IM239715099590217402
B6431415099590666323