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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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RESIST-5 O.K.N.V.I. Carbapenemases… — 1 UDI-DI variant, IVDR

MD Atlas
Coris BioConcept

Data from EUDAMED, last updated May 31, 2026

RESIST-5 O.K.N.V.I. Carbapenemases rapid test

54200719K15R11WF

1 UDI-DI variant

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: Coris BioConcept

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Device characteristics

ReagentProfessional testing

Identity & classification

Basic UDI-DI: 54200719K15R11WF
Device name: RESIST-5 O.K.N.V.I. Carbapenemases rapid test
Device model: K-15R11
Issuing agency: GS1
Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class B
Version date: May 21, 2026

Manufacturer & authorised representative

Manufacturer

Name: Coris BioConcept
SRN: BE-MF-000024520
Country: Belgium
Email: info@corisbio.com
Phone: +32 (0)81 719 917

Variants by status

UDI-DI variants

1 UDI-DI variant

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Export results

Applied filters

basicUdiUlid01KS563SZXEJ6HRHNKR2RXCNWM

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

RESIST-5 O.K.N.V.I. Carbapenemases rapid test15420071900702