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MicroScan Neg MIC 61

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-C63726WD
Basic UDI-DI: B-C63726WD
Reference: C63726
EMDN: W0104080101
EMDN description: GRAM NEGATIVE IDENTIFICATION - AUTOMATED
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 13.07.2026 03:54

Manufacturer products Authorised representative products Authorised representative actors View details

MicroScan Neg MIC 57

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-C58012VP
Basic UDI-DI: B-C58012VP
Reference: C58012
EMDN: W0104080101
EMDN description: GRAM NEGATIVE IDENTIFICATION - AUTOMATED
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 13.07.2026 03:54

Manufacturer products Authorised representative products Authorised representative actors View details

Sentosa SA vanA/vanB PCR Test

300015, 300016

IVD generalIVDDOn the marketKitMicrobial substancesReagentSingle use

Manufacturer: Vela Operations Singapore Pte. Ltd.
Manufacturer SRN: SG-MF-000025684
UDI-DI: D-888501395SSAvanABT3Q
Basic UDI-DI: B-888501395SSAvanABT3Q
Reference: 300015, 300016
EMDN: W0104080604
EMDN description: NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED VRE
First on market country: Germany
Authorised representative: Vela Diagnostics Germany GmbH
Last updated: 12.07.2026 20:29

Manufacturer products Authorised representative products Authorised representative actors View details

RevoDx Carbapenem resistance (blaNDM, blaKPC, blaIMP, blaOXA48, blaVIM) qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: D-8683079717486E6
Basic UDI-DI: B-8683079717486E6
Reference: IP202207-100
EMDN: W0104080606
EMDN description: NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED CARBAPENEMASE
First on market country: Italy
Authorised representative: -
Last updated: 12.07.2026 16:23

Manufacturer products View details

Carbapenemase Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.
Manufacturer SRN: CN-MF-000013495
UDI-DI: 16972698601443
Basic UDI-DI: B-16972698601443
Reference: P261102
EMDN: W0104080506
EMDN description: TARGETED RESISTANCE TESTS - CARBAPENEMASE
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 09:52

Manufacturer products Authorised representative products Authorised representative actors View details

MCR-1 Enzyme Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.
Manufacturer SRN: CN-MF-000013495
UDI-DI: 16972698601238
Basic UDI-DI: B-16972698601238
Reference: P261105
EMDN: W0104080590
EMDN description: TARGETED RESISTANCE TESTS - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 09:52

Manufacturer products Authorised representative products Authorised representative actors View details

CTX-M β-lactamases Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.
Manufacturer SRN: CN-MF-000013495
UDI-DI: 16972698601221
Basic UDI-DI: B-16972698601221
Reference: P261104
EMDN: W0104080505
EMDN description: TARGETED RESISTANCE TESTS - ESBL
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 09:52

Manufacturer products Authorised representative products Authorised representative actors View details

OXA-23 Carbapenemase Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.
Manufacturer SRN: CN-MF-000013495
UDI-DI: 16972698601214
Basic UDI-DI: B-16972698601214
Reference: P261103
EMDN: W0104080506
EMDN description: TARGETED RESISTANCE TESTS - CARBAPENEMASE
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 09:52

Manufacturer products Authorised representative products Authorised representative actors View details

GBS Screen Broth

M131002

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.
Manufacturer SRN: CN-MF-000013495
UDI-DI: 16972698601061
Basic UDI-DI: B-16972698601061
Reference: M131002
EMDN: W0104080203
EMDN description: GRAM POSITIVE - MANUAL IDENTIFICATION
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 11.07.2026 09:51

Manufacturer products Authorised representative products Authorised representative actors View details

GBS Screen Broth

M131001

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.
Manufacturer SRN: CN-MF-000013495
UDI-DI: 16972698601054
Basic UDI-DI: B-16972698601054
Reference: M131001
EMDN: W0104080203
EMDN description: GRAM POSITIVE - MANUAL IDENTIFICATION
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 11.07.2026 09:51

Manufacturer products Authorised representative products Authorised representative actors View details

RESIST-1 MCR Multi Mobilised colistin resistance rapid test

K-13R15

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Coris BioConcept
Manufacturer SRN: BE-MF-000024520
UDI-DI: 15420071901006
Basic UDI-DI: B-15420071901006
Reference: K-13R15
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

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

TruVue

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