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RESIST-1 MCR Multi Mobilised colistin resistance rapid test

K-15R15

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Coris BioConcept
Manufacturer SRN: BE-MF-000024520
UDI-DI: 15420071900993
Basic UDI-DI: B-15420071900993
Reference: K-15R15
EMDN: W0104080590
EMDN description: TARGETED RESISTANCE TESTS - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 11.07.2026 08:44

Manufacturer products View details

Carbapenem Resistant Enterobacteriaceae assay (LFA)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763389
Basic UDI-DI: B-15065023763389
Reference: TV10039
EMDN: W0104080506
EMDN description: TARGETED RESISTANCE TESTS - CARBAPENEMASE
First on market country: Poland
Authorised representative: SUNGO Europe B.V.
Last updated: 11.07.2026 08:35

Manufacturer products Authorised representative products Authorised representative actors View details

RIDA®Plex CRE EU 16 well Step 1

RIDA®Plex CRE EU 16 well

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044006463
Basic UDI-DI: B-09343044006463
Reference: 21099S
EMDN: W0104080606
EMDN description: NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED CARBAPENEMASE
First on market country: Germany
Authorised representative: R-Biopharm AG
Last updated: 10.07.2026 23:44

Manufacturer products Authorised representative products Authorised representative actors View details

RIDA®Plex CRE EU 16 well Step 2

RIDA®Plex CRE EU 16 well

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044006456
Basic UDI-DI: B-09343044006456
Reference: 21099P
EMDN: W0104080606
EMDN description: NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED CARBAPENEMASE
First on market country: Germany
Authorised representative: R-Biopharm AG
Last updated: 10.07.2026 23:44

Manufacturer products Authorised representative products Authorised representative actors View details

RIDA®Plex CRE 16 well Step 1

RIDA®Plex CRE 16 well

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044006449
Basic UDI-DI: B-09343044006449
Reference: 21098S
EMDN: W0104080606
EMDN description: NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED CARBAPENEMASE
First on market country: Germany
Authorised representative: R-Biopharm AG
Last updated: 10.07.2026 23:44

Manufacturer products Authorised representative products Authorised representative actors View details

RIDA®Plex CRE 16 well Step 2

RIDA®Plex CRE 16 well

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044006432
Basic UDI-DI: B-09343044006432
Reference: 21098P
EMDN: W0104080606
EMDN description: NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED CARBAPENEMASE
First on market country: Germany
Authorised representative: R-Biopharm AG
Last updated: 10.07.2026 23:44

Manufacturer products Authorised representative products Authorised representative actors View details

CRE Reference 24-well

Step 1 tubes for CRE Reference 24-well

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044004742
Basic UDI-DI: B-09343044004742
Reference: 81099S
EMDN: W0104080606
EMDN description: NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED CARBAPENEMASE
First on market country: Malta
Authorised representative: Advena Limited
Last updated: 10.07.2026 23:43

Manufacturer products Authorised representative products Authorised representative actors View details

CRE Reference 24-well

Step 2 Plates for CRE Reference 24-well

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044004735
Basic UDI-DI: B-09343044004735
Reference: 81099P
EMDN: W0104080606
EMDN description: NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED CARBAPENEMASE
First on market country: Malta
Authorised representative: Advena Limited
Last updated: 10.07.2026 23:43

Manufacturer products Authorised representative products Authorised representative actors View details

Step 1 tubes for CRE EU 16-well

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044002656
Basic UDI-DI: B-09343044002656
Reference: 21099S
EMDN: W0104080606
EMDN description: NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED CARBAPENEMASE
First on market country: Malta
Authorised representative: Advena Limited
Last updated: 10.07.2026 23:42

Manufacturer products Authorised representative products Authorised representative actors View details

Step 2 Plates for CRE EU 16-well

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044002649
Basic UDI-DI: B-09343044002649
Reference: 21099P
EMDN: W0104080606
EMDN description: NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED CARBAPENEMASE
First on market country: Malta
Authorised representative: Advena Limited
Last updated: 10.07.2026 23:42

Manufacturer products Authorised representative products Authorised representative actors View details

Step 1 tubes for CRE 16-well

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044002205
Basic UDI-DI: B-09343044002205
Reference: 21098S
EMDN: W0104080606
EMDN description: NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED CARBAPENEMASE
First on market country: Malta
Authorised representative: Advena Limited
Last updated: 10.07.2026 23:42

Manufacturer products Authorised representative products Authorised representative actors View details

Step 2 Plates for CRE 16-well

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044002199
Basic UDI-DI: B-09343044002199
Reference: 21098P
EMDN: W0104080606
EMDN description: NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED CARBAPENEMASE
First on market country: Malta
Authorised representative: Advena Limited
Last updated: 10.07.2026 23:42

Manufacturer products Authorised representative products Authorised representative actors View details

Allplex™ Entero-DR Assay

Allplex™ Entero-DR Assay

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240103845
Basic UDI-DI: B-08809240103845
Reference: CR10384Z
EMDN: W0104080607
EMDN description: NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED OTHER RESISTANCE MARKERS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 12:45

Manufacturer products Authorised representative products Authorised representative actors View details

Allplex™ Entero-DR Assay

Allplex™ Entero-DR Assay

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240101070
Basic UDI-DI: B-08809240101070
Reference: CR9700X
EMDN: W0104080607
EMDN description: NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED OTHER RESISTANCE MARKERS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 12:43

Manufacturer products Authorised representative products Authorised representative actors View details

Allplex™ Entero-DR Assay

Allplex™ Entero-DR Assay

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240101063
Basic UDI-DI: B-08809240101063
Reference: CR9700Y
EMDN: W0104080607
EMDN description: NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED OTHER RESISTANCE MARKERS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 12:43

Manufacturer products Authorised representative products Authorised representative actors View details

QMdRASTN02, QMdRASTP02, QMdRASTN03, QMdRASTP03, QMdRASTN05

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: QuantaMatrix Inc.
Manufacturer SRN: KR-MF-000022784
UDI-DI: 08800044300065
Basic UDI-DI: B-08800044300065
Reference: QMdRASTN02, QMdRASTP02, QMdRASTN03, QMdRASTP03, QMdRASTN05
EMDN: W0104080108
EMDN description: GRAM POSITIVE SUSCEPTIBILITY TESTING - AUTOMATED
First on market country: France
Authorised representative: KTR Europe GmbH
Last updated: 10.07.2026 01:26

Manufacturer products Authorised representative products Authorised representative actors View details

DermaGenius® Resistance Multiplex real-time PCR kit

PN-303

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: PathoNostics B.V.
Manufacturer SRN: NL-MF-000002705
UDI-DI: 08719327498002
Basic UDI-DI: B-08719327498002
Reference: PN-303
EMDN: W0104080607
EMDN description: NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED OTHER RESISTANCE MARKERS
First on market country: Netherlands
Authorised representative: -
Last updated: 09.07.2026 19:05

Manufacturer products View details

Fluorion VRE QLP 1.0 Real-Time PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: IONTEK ILAC TANI VE BIYOTEKNOLOJI URUNLERI AR. GE. SAN. TIC. A.S.
Manufacturer SRN: TR-MF-000023054
UDI-DI: 08698898740539
Basic UDI-DI: B-08698898740539
Reference: M0630102
EMDN: W0104080604
EMDN description: NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED VRE
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 15:00

Manufacturer products View details

CEFTOBIPROLE 30 µg ANTIMICROBIAL SUSCEPTIBILITY TEST DISCS

ASD09631

IVD generalIVDDOn the marketMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Bioanalyse Tıbbi Malzemeler Sanayi ve Ticaret Anonim Şirketi
Manufacturer SRN: TR-MF-000046898
UDI-DI: 08698874205137
Basic UDI-DI: B-08698874205137
Reference: ASD09631
EMDN: W0104080503
EMDN description: MANUAL ANTIMICROBIAL SUCEPTIBILITY TESTING (AST)- STRIPS / CASSETTES/GALLERIES
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 14:55

Manufacturer products View details

AMPICILLIN 2 µg ANTIMICROBIAL SUSCEPTIBILITY TEST DISCS

ASD00190

IVD generalIVDDOn the marketMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Bioanalyse Tıbbi Malzemeler Sanayi ve Ticaret Anonim Şirketi
Manufacturer SRN: TR-MF-000046898
UDI-DI: 08698874204475
Basic UDI-DI: B-08698874204475
Reference: ASD00190
EMDN: W0104080503
EMDN description: MANUAL ANTIMICROBIAL SUCEPTIBILITY TESTING (AST)- STRIPS / CASSETTES/GALLERIES
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 14:55

Manufacturer products View details