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AMP

IVD generalIVDDOn the marketProfessional testingSingle use

Manufacturer: Diagnostics s.r.o.
Manufacturer SRN: SK-MF-000038255
UDI-DI: 08588007926414
Basic UDI-DI: B-08588007926414
Reference: 8002
EMDN: W0104080501
EMDN description: MIC SYSTEMS - DILUTION METHODS (INCL. E-TEST)
First on market country: Slovakia
Authorised representative: -
Last updated: 08.07.2026 01:25

Manufacturer products View details

AMK

IVD generalIVDDOn the marketProfessional testingSingle use

Manufacturer: Diagnostics s.r.o.
Manufacturer SRN: SK-MF-000038255
UDI-DI: 08588007926407
Basic UDI-DI: B-08588007926407
Reference: 8001
EMDN: W0104080501
EMDN description: MIC SYSTEMS - DILUTION METHODS (INCL. E-TEST)
First on market country: Slovakia
Authorised representative: -
Last updated: 08.07.2026 01:25

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MIC ENC

IVD generalIVDDOn the marketProfessional testingSingle use

Manufacturer: Diagnostics s.r.o.
Manufacturer SRN: SK-MF-000038255
UDI-DI: 08588007926391
Basic UDI-DI: B-08588007926391
Reference: 7006
EMDN: W0104080501
EMDN description: MIC SYSTEMS - DILUTION METHODS (INCL. E-TEST)
First on market country: Slovakia
Authorised representative: -
Last updated: 08.07.2026 01:25

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MIC YST

IVD generalIVDDOn the marketProfessional testingSingle use

Manufacturer: Diagnostics s.r.o.
Manufacturer SRN: SK-MF-000038255
UDI-DI: 08588007926384
Basic UDI-DI: B-08588007926384
Reference: 7005
EMDN: W0104080501
EMDN description: MIC SYSTEMS - DILUTION METHODS (INCL. E-TEST)
First on market country: Slovakia
Authorised representative: -
Last updated: 08.07.2026 01:25

Manufacturer products View details

MIC GP

IVD generalIVDDOn the marketProfessional testingSingle use

Manufacturer: Diagnostics s.r.o.
Manufacturer SRN: SK-MF-000038255
UDI-DI: 08588007926360
Basic UDI-DI: B-08588007926360
Reference: 7004
EMDN: W0104080501
EMDN description: MIC SYSTEMS - DILUTION METHODS (INCL. E-TEST)
First on market country: Slovakia
Authorised representative: -
Last updated: 08.07.2026 01:25

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MIC GN2

IVD generalIVDDOn the marketProfessional testingSingle use

Manufacturer: Diagnostics s.r.o.
Manufacturer SRN: SK-MF-000038255
UDI-DI: 08588007926353
Basic UDI-DI: B-08588007926353
Reference: 7002
EMDN: W0104080501
EMDN description: MIC SYSTEMS - DILUTION METHODS (INCL. E-TEST)
First on market country: Slovakia
Authorised representative: -
Last updated: 08.07.2026 01:25

Manufacturer products View details

MIC GN1

IVD generalIVDDOn the marketProfessional testingSingle use

Manufacturer: Diagnostics s.r.o.
Manufacturer SRN: SK-MF-000038255
UDI-DI: 08588007926346
Basic UDI-DI: B-08588007926346
Reference: 7001
EMDN: W0104080501
EMDN description: MIC SYSTEMS - DILUTION METHODS (INCL. E-TEST)
First on market country: Slovakia
Authorised representative: -
Last updated: 08.07.2026 01:25

Manufacturer products View details

KarbaDia Rapid Test

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

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

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

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

Duplex Real-time PCR Detection Kit for Superbacteria (MRSA)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06974323012238
Basic UDI-DI: B-06974323012238
Reference: A2942-50T
EMDN: W0104080504
EMDN description: TARGETED RESISTANCE TESTS - MRSA
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 18:49

Manufacturer products Authorised representative products Authorised representative actors View details

Duplex Real-time PCR Detection Kit for Superbacteria (MRSA)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06974323012221
Basic UDI-DI: B-06974323012221
Reference: A2942-25T
EMDN: W0104080504
EMDN description: TARGETED RESISTANCE TESTS - MRSA
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 18:49

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

UMIC Daptomycin

UMIC Daptomycin

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Bruker Daltonics GmbH & Co. KG
Manufacturer SRN: DE-MF-000024392
UDI-DI: 04251204326960
Basic UDI-DI: B-04251204326960
Reference: UM-DAP-040
EMDN: W0104080501
EMDN description: MIC SYSTEMS - DILUTION METHODS (INCL. E-TEST)
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 07:41

Manufacturer products View details

UMIC Piperacillin-Tazobactam

UMIC Piperacillin-Tazobactam

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Bruker Daltonics GmbH & Co. KG
Manufacturer SRN: DE-MF-000024392
UDI-DI: 04251204326946
Basic UDI-DI: B-04251204326946
Reference: UM-PIT-040
EMDN: W0104080501
EMDN description: MIC SYSTEMS - DILUTION METHODS (INCL. E-TEST)
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 07:41

Manufacturer products View details

UMIC Vancomycin/Teicoplanin

UMIC Vancomycin/Teicoplanin

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Bruker Daltonics GmbH & Co. KG
Manufacturer SRN: DE-MF-000024392
UDI-DI: 04251204326939
Basic UDI-DI: B-04251204326939
Reference: UM-VAN/TEI-040
EMDN: W0104080501
EMDN description: MIC SYSTEMS - DILUTION METHODS (INCL. E-TEST)
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 07:41

Manufacturer products View details

UMIC Colistin

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Bruker Daltonics GmbH & Co. KG
Manufacturer SRN: DE-MF-000024392
UDI-DI: 04251204326922
Basic UDI-DI: B-04251204326922
Reference: UM-COL-040
EMDN: W0104080501
EMDN description: MIC SYSTEMS - DILUTION METHODS (INCL. E-TEST)
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 07:41

Manufacturer products View details

Enterecoccus spp./Van A/B Genotyping qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684998276429
Basic UDI-DI: 868521452PCR150G3
Reference: CFP150P25
EMDN: W0104080590
EMDN description: TARGETED RESISTANCE TESTS - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 03.07.2026 18:39

Manufacturer products View details