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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-5 O.K.N.V.I. Carbapenemases… — IVDR Class B IVDR

MD Atlas
Coris BioConcept

EUDAMED last updated this device on May 28, 2026

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

54200719K15R11WF

On the marketIVDR Class B

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Coris BioConcept
UDI-DI code: 15420071900702
Reference / catalog number: K-15R11

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View device family (Basic UDI)

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 15, 2026	Still on market

Device identification

Trade name: RESIST-5 O.K.N.V.I. Carbapenemases rapid test
UDI-DI code: 15420071900702
Basic UDI-DI: 54200719K15R11WF
Reference / catalog number: K-15R11
Issuing entity: GS1

Classification

Risk category: IVDR Class B
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 20
Additional product description: Rapid in vitro diagnostic medical device based on immunochromatography for the visual and qualitative detection of OXA-48, KPC, NDM, VIM and IMP carbapenemases in bacterial culture (agar plate, blood or rectal swab), to aid in diagnostic of antimicrobial resistance mechanism in a 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

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)15420071900702

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

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

W0104080506TARGETED RESISTANCE TESTS - CARBAPENEMASE

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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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.