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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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GCAL®NEPH Calprotectin — 3 UDI-DI variants, IVDR (Gentian AS)

MD Atlas
Gentian AS

Data from EUDAMED, last updated May 30, 2026

GCAL®NEPH Calprotectin

9003846B02GCAL003E2

3 UDI-DI variants

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

Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class B
Manufacturer: Gentian AS

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Device characteristics

ReagentProfessional testingAnimal tissues / cells

Identity & classification

Basic UDI-DI: 9003846B02GCAL003E2
Device name: GCAL®NEPH Calprotectin
Device model: 1701
Issuing agency: GS1
Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class B
Version date: Oct 28, 2021

Manufacturer & authorised representative

Manufacturer

Name: Gentian AS
SRN: NO-MF-000003448
Country: Norway
Email: info@gentian.com
Phone: +4799339905

Variants by status

UDI-DI variants

3 UDI-DI variants

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Applied filters

basicUdiUlid01FJHJT3ZEFR7887W196PFSPDG

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

GCAL®NEPH Calibrator07090038460214
GCAL®NEPH Calprotectin07090038460207
GCAL®NEPH Controls07090038460221