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18 device results listed.

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RapidFor™ CARBA Test Kit

VMD182SC

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685214526922
Basic UDI-DI: 868521452VMD182SCZJ
Reference: VMD182
EMDN: W0104080506
EMDN description: TARGETED RESISTANCE TESTS - CARBAPENEMASE
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 23:29

Manufacturer products View details

RAPIDEC® CARBA NP

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026459543
Basic UDI-DI: 357302BUDI000749UB
Reference: 417498
EMDN: W0104080506
EMDN description: TARGETED RESISTANCE TESTS - CARBAPENEMASE
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:04

Manufacturer products View details

RAPIDEC® CARBA NP

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026433659
Basic UDI-DI: 357302BUDI000749UB
Reference: 415418
EMDN: W0104080506
EMDN description: TARGETED RESISTANCE TESTS - CARBAPENEMASE
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:57

Manufacturer products View details

KPC/IMP/NDM/VIM/OXA-48 Combo Test Kit (LFIA)

211045-20-061

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Jiangsu Medomics Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000030226
UDI-DI: D-211045-20-061CQ
Basic UDI-DI: B-211045-20-061CQ
Reference: 211045-20-061
EMDN: W0104080506
EMDN description: TARGETED RESISTANCE TESTS - CARBAPENEMASE
First on market country: Poland
Authorised representative: R Sight B.V.
Last updated: 17.07.2026 01:49

Manufacturer products Authorised representative products Authorised representative actors View details

KPC/IMP/NDM/VIM/OXA-48 Combo Test Kit (LFIA)

211045-01-061

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Jiangsu Medomics Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000030226
UDI-DI: D-211045-01-061C9
Basic UDI-DI: B-211045-01-061C9
Reference: 211045-01-061
EMDN: W0104080506
EMDN description: TARGETED RESISTANCE TESTS - CARBAPENEMASE
First on market country: Poland
Authorised representative: R Sight B.V.
Last updated: 17.07.2026 01:49

Manufacturer products Authorised representative products Authorised representative actors View details

CARBA 5 In 1 Rapid Test Cassette

GCCRE-T1402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCCRE-T1402aHGFX
Basic UDI-DI: B-GCCRE-T1402aHGFX
Reference: GCCRE-T1402a
EMDN: W0104080506
EMDN description: TARGETED RESISTANCE TESTS - CARBAPENEMASE
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:25

Manufacturer products Authorised representative products Authorised representative actors 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

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

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

RapidFor™ Antimicrobial Resistance Test Kit

VMD111SC

IVD generalIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595030493
Basic UDI-DI: B-08684595030493
Reference: VMD111
EMDN: W0104080506
EMDN description: TARGETED RESISTANCE TESTS - CARBAPENEMASE
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 06:14

Manufacturer products View details

KarbaDia Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: GaDia SA
Manufacturer SRN: CH-MF-000031123
UDI-DI: 07649990065052
Basic UDI-DI: B-07649990065052
Reference: KAR-025
EMDN: W0104080506
EMDN description: TARGETED RESISTANCE TESTS - CARBAPENEMASE
First on market country: France
Authorised representative: ER Egészségügyi, Kereskedelmi és Szolgáltató Kft.
Last updated: 07.07.2026 07:03

Manufacturer products Authorised representative products Authorised representative actors View details

Carbapenemase Rapid Test Cassette -KPC/NDM/VIM/IMP/OXA-48

Carbapenemase Rapid Test Cassette-KPC/NDM/VIM/IMP/OXA-48

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Tianjin Jianbo Biological Co., Ltd.
Manufacturer SRN: CN-MF-000040307
UDI-DI: 06975344570110
Basic UDI-DI: B-06975344570110
Reference: C6003
EMDN: W0104080506
EMDN description: TARGETED RESISTANCE TESTS - CARBAPENEMASE
First on market country: Greece
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 22:28

Manufacturer products Authorised representative products Authorised representative actors View details

06974323019558

Carbapenemase test cassette (Lateral Flow Method)

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06974323019558
Basic UDI-DI: B-06974323019558
Reference: IC002
EMDN: W0104080506
EMDN description: TARGETED RESISTANCE TESTS - CARBAPENEMASE
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 19:04

Manufacturer products Authorised representative products Authorised representative actors View details

06974323019541

Carbapenemase test cassette (Lateral Flow Method)

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06974323019541
Basic UDI-DI: B-06974323019541
Reference: IC002
EMDN: W0104080506
EMDN description: TARGETED RESISTANCE TESTS - CARBAPENEMASE
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 19:04

Manufacturer products Authorised representative products Authorised representative actors View details

06974323019534

Carbapenemase test cassette (Lateral Flow Method)

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06974323019534
Basic UDI-DI: B-06974323019534
Reference: IC002
EMDN: W0104080506
EMDN description: TARGETED RESISTANCE TESTS - CARBAPENEMASE
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 19:04

Manufacturer products Authorised representative products Authorised representative actors View details

KPC/IMP/NDM/VIM/OXA-48 Combo Test Kit (LFIA)

211045-20-01

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Jiangsu Medomics Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000030226
UDI-DI: 06974167891860
Basic UDI-DI: B-06974167891860
Reference: 211045-20-01
EMDN: W0104080506
EMDN description: TARGETED RESISTANCE TESTS - CARBAPENEMASE
First on market country: Austria
Authorised representative: R Sight B.V.
Last updated: 06.07.2026 17:57

Manufacturer products Authorised representative products Authorised representative actors View details

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

K-15R11

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Coris BioConcept
Manufacturer SRN: BE-MF-000024520
UDI-DI: 15420071900702
Basic UDI-DI: 54200719K15R11WF
Reference: K-15R11
EMDN: W0104080506
EMDN description: TARGETED RESISTANCE TESTS - CARBAPENEMASE
First on market country: Belgium
Authorised representative: -
Last updated: 02.07.2026 04:06

Manufacturer products View details

RESIST-3 O.K.N. Carbapenemases rapid test

K-15R5

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Coris BioConcept
Manufacturer SRN: BE-MF-000024520
UDI-DI: 15420071900603
Basic UDI-DI: 54200719K15R55R
Reference: K-15R5
EMDN: W0104080506
EMDN description: TARGETED RESISTANCE TESTS - CARBAPENEMASE
First on market country: Belgium
Authorised representative: -
Last updated: 02.07.2026 04:06

Manufacturer products View details