Pricing Sign in

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Partners Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Gentian Calprotectin Reagent Kit — 4 UDI-DI variants, IVDR

MD Atlas
Gentian AS

Data from EUDAMED, last updated May 30, 2026

Gentian Calprotectin Reagent Kit

9003846B02GCAL002DY

4 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

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Device characteristics

ReagentProfessional testingAnimal tissues / cells

Identity & classification

Basic UDI-DI: 9003846B02GCAL002DY
Device name: Gentian Calprotectin Reagent Kit
Device model: 1201
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

4 UDI-DI variants

Sign in to export

Exports are reserved for signed-in users. Sign in or create an account to continue.

Email

Password

No account yet?

Export results

Applied filters

basicUdiUlid01FJHHQXCKPKYHHPHJ0XCS1JQD

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

Gentian GCAL® Calprotectin Calibrator Kit07090038460191
Gentian GCAL® Calprotectin Control Kit07090038460160
Gentian GCAL® Calprotectin Reagent Kit07090038460139
Gentian GCAL® Calprotectin Reagent Kit S07090038460269