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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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AMACR (QR108) — 7 UDI-DI variants, IVDR

MD Atlas
biocyc Biotechnologie GmbH & Co. KG

Data from EUDAMED, last updated May 23, 2026

AMACR (QR108)

42555978ANTIBODYA0042T

7 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: biocyc Biotechnologie GmbH & Co. KG

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Device characteristics

ReagentProfessional testingHuman tissues / cellsAnimal tissues / cells

Identity & classification

Basic UDI-DI: 42555978ANTIBODYA0042T
Device name: AMACR (QR108)
Issuing agency: GS1
Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class C
Version date: Nov 24, 2025

Manufacturer & authorised representative

Manufacturer

Name: biocyc Biotechnologie GmbH & Co. KG
SRN: DE-MF-000031533
Country: Germany
Email: info@biocyc.de
Phone: +4933196782600

Variants by status

UDI-DI variants

7 UDI-DI variants

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Export results

Applied filters

basicUdiUlid01KATMBP7K4BTJB0GMHHSJBS1M

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

P-A004-15004255597803442
C-A004-1004255597803411
P-A004-7004255597803435
C-A004-0504255597803404
C-A004-0104255597803398
C-A004-02504255597803862
P-A004-3004255597803428