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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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D-dimer FEU Calibrator — 2 UDI-DI variants, IVDR (Nordic Biomarker AB)

MD Atlas
Nordic Biomarker AB

Data from EUDAMED, last updated May 31, 2026

D-dimer FEU Calibrator

7350060320297A

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: Nordic Biomarker AB

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Device characteristics

ReagentProfessional testingHuman tissues / cellsAnimal tissues / cells

Identity & classification

Basic UDI-DI: 7350060320297A
Device name: D-dimer FEU Calibrator
Issuing agency: GS1
Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class C
Version date: Apr 10, 2026

Manufacturer & authorised representative

Manufacturer

Name: Nordic Biomarker AB
SRN: SE-MF-000022201
Country: Sweden
Email: info@nordicbiomarker.com

Variants by status

UDI-DI variants

2 UDI-DI variants

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Applied filters

basicUdiUlid01KNV9T5T1WXES2Y690CQ6B6F7

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

SC105K27350060320509
K504527350060320370