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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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PRAME (QR005) — 8 UDI-DI variants, IVDR

MD Atlas
biocyc Biotechnologie GmbH & Co. KG

Data from EUDAMED, last updated May 23, 2026

PRAME (QR005)

42555978ANTIBODYAW

8 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: 42555978ANTIBODYAW
Device name: PRAME (QR005)
Issuing agency: GS1
Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class C
Version date: Jun 27, 2024

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

8 UDI-DI variants

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Applied filters

basicUdiUlid01J1C6G5W415ZAG8JDKKC7WDH7

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

C-P003-0104255597801431
C-P003-1004255597801417
P-P003-7004255597801387
C-P003-05004255597803381
PRAME (QR005)04255597801424
P-P003-15004255597801400
C-P003-02504255597801370
P-P003-3004255597801394