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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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Organization name
UDI-DI code
Reference / catalog number

RESIST-1 MCR Multi Mobilised… — IVDD — General IVDD

MD Atlas
Coris BioConcept

EUDAMED last updated this device on May 28, 2026

RESIST-1 MCR Multi Mobilised colistin resistance rapid test

B-15420071900993

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Coris BioConcept
UDI-DI code: 15420071900993
Reference / catalog number: K-15R15

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Manufacturer information

Organization name: Coris BioConcept
SRN: BE-MF-000024520
Manufacturer status: Active

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Belgium; available across 1 country total.

Country	On market since	Until
BelgiumPrimary placement	May 28, 2026	Dec 31, 2029

Device identification

Trade name: RESIST-1 MCR Multi Mobilised colistin resistance rapid test
UDI-DI code: 15420071900993
Basic UDI-DI: B-15420071900993
Reference / catalog number: K-15R15
Issuing entity: GS1

Classification

Risk category: IVDD — General
Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Rapid in vitro diagnostic medical device based on immunochromatography for the visual and qualitative detection of some MCR enzymes in bacterial culture from human biologic sample, to aid in diagnostic of antimicrobial resistance mechanism in hospitalized patients or individuals at risk of infection or colonization. For professional use only and not automated.
Additional information URL: https://www.corisbio.com/products/
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

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Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)15420071900993

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

W0104080590TARGETED RESISTANCE TESTS - OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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Related devices

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Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.