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04250592366060

eazyplex® SuperBug AmpC

IVD Class CIVDR 2017/746On the marketKitProfessional testingSingle use

Manufacturer: AmplexDiagnostics GmbH
Manufacturer SRN: DE-MF-000014117
UDI-DI: 04250592366060
Basic UDI-DI: 42505923AMPCJX
Reference: 7606
EMDN: W0104080607
EMDN description: NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED OTHER RESISTANCE MARKERS
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 00:42

Manufacturer products View details

MDR-Q Real-Time PCR Kit

G2M707521

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagent

Manufacturer: Genes 2Me Private Limited
Manufacturer SRN: IN-MF-000035953
UDI-DI: D-G2M707521G5
Basic UDI-DI: B-G2M707521G5
Reference: G2M707521,G2M707521R
EMDN: W0104080607
EMDN description: NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED OTHER RESISTANCE MARKERS
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 13.07.2026 23:44

Manufacturer products Authorised representative products Authorised representative actors View details

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

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

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

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

06974323012412

Multiplex PCR Diagnostic Kit for Rapid Identification of Drug-resistance Gene of Salmonella

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06974323012412
Basic UDI-DI: B-06974323012412
Reference: A513L-50T
EMDN: W0104080607
EMDN description: NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED OTHER RESISTANCE MARKERS
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 18:50

Manufacturer products Authorised representative products Authorised representative actors View details

06974323012405

Multiplex PCR Diagnostic Kit for Rapid Identification of Drug-resistance Gene of Salmonella

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06974323012405
Basic UDI-DI: B-06974323012405
Reference: A513L-25T
EMDN: W0104080607
EMDN description: NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED OTHER RESISTANCE MARKERS
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 18:50

Manufacturer products Authorised representative products Authorised representative actors View details

06974323012399

Multiplex PCR Diagnostic Kit for Rapid Identification of Drug-resistance Gene of Polymyxin

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06974323012399
Basic UDI-DI: B-06974323012399
Reference: A7388-50T
EMDN: W0104080607
EMDN description: NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED OTHER RESISTANCE MARKERS
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 18:50

Manufacturer products Authorised representative products Authorised representative actors View details

06974323012382

Multiplex PCR Diagnostic Kit for Rapid Identification of Drug-resistance Gene of Polymyxin

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06974323012382
Basic UDI-DI: B-06974323012382
Reference: A7388-25T
EMDN: W0104080607
EMDN description: NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED OTHER RESISTANCE MARKERS
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 18:50

Manufacturer products Authorised representative products Authorised representative actors View details

Allplex™ MDRO Assay

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240102886
Basic UDI-DI: 924010MR10289KS
Reference: MR10288Z
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: 04.07.2026 00:02

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® Rifampicin & Isoniazid Resistant MTB Detection Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08908015304835
Basic UDI-DI: 89080153043B1280L8
Reference: 3B1280/C
EMDN: W0104080607
EMDN description: NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED OTHER RESISTANCE MARKERS
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 03.07.2026 22:07

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® UTI AST Panel Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08906213930399
Basic UDI-DI: 89080153043B343NJ
Reference: 3B343/C
EMDN: W0104080607
EMDN description: NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED OTHER RESISTANCE MARKERS
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 03.07.2026 22:03

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® AST Panel Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08906213930368
Basic UDI-DI: 8906213933B361YT
Reference: 3B361/C
EMDN: W0104080607
EMDN description: NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED OTHER RESISTANCE MARKERS
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 03.07.2026 21:55

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® UTI ID Panel Kit

IVD Class CIVDR 2017/746On the marketKitReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08906213930245
Basic UDI-DI: 8906213933B319YU
Reference: 3B319/C
EMDN: W0104080607
EMDN description: NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED OTHER RESISTANCE MARKERS
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 03.07.2026 21:55

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® Rifampicin Resistant MTB Detection Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08906213930276
Basic UDI-DI: 8906213933B1281SV
Reference: 3B1281/C
EMDN: W0104080607
EMDN description: NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED OTHER RESISTANCE MARKERS
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 03.07.2026 21:55

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® Rifampicin & Isoniazid Resistant MTB Detection Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08908015304842
Basic UDI-DI: 89080153043B1280L8
Reference: 3B1280
EMDN: W0104080607
EMDN description: NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED OTHER RESISTANCE MARKERS
First on market country: -
Authorised representative: Wellkang Ltd
Last updated: 29.06.2026 11:20

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® Rifampicin & Isoniazid Resistant MTB Detection Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08908015304859
Basic UDI-DI: 89080153043B1280L8
Reference: 3B1275
EMDN: W0104080607
EMDN description: NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED OTHER RESISTANCE MARKERS
First on market country: -
Authorised representative: Wellkang Ltd
Last updated: 29.06.2026 11:20

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® UTI AST Panel Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08906213930405
Basic UDI-DI: 89080153043B343NJ
Reference: 3B343
EMDN: W0104080607
EMDN description: NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED OTHER RESISTANCE MARKERS
First on market country: -
Authorised representative: Wellkang Ltd
Last updated: 27.06.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® UTI AST Panel Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08906213930412
Basic UDI-DI: 89080153043B343NJ
Reference: 3B344
EMDN: W0104080607
EMDN description: NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED OTHER RESISTANCE MARKERS
First on market country: -
Authorised representative: Wellkang Ltd
Last updated: 27.06.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details