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37 device results listed.

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AccuPower® HBV Quant Kit (ExiStation™ FA 96)

IVD Class DNot specifiedOn the market

Manufacturer: BIONEER Corporation
Manufacturer SRN: KR-MF-000018672
UDI-DI: 08800242990068
Basic UDI-DI: 880953707HBV3116NB
Reference: HBV-3116
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 22.09.2026 07:56

Manufacturer products Authorised representative products Authorised representative actors View details

AccuPower® HCV Quant Kit (ExiStation™ FA 96)

IVD Class DNot specifiedOn the market

Manufacturer: BIONEER Corporation
Manufacturer SRN: KR-MF-000018672
UDI-DI: 08800242990075
Basic UDI-DI: 880953707HCV3116NQ
Reference: HCV-3116
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 22.09.2026 07:54

Manufacturer products Authorised representative products Authorised representative actors View details

AccuPower® RV Kit (ExiStation™ FA 96)

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: BIONEER Corporation
Manufacturer SRN: KR-MF-000018672
UDI-DI: 08809537078740
Basic UDI-DI: 880953707RVP3116ZP
Reference: RVP-3116
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:59

Manufacturer products Authorised representative products Authorised representative actors View details

ExiCycler™ V5 96

ExiCycler™ V5

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: BIONEER Corporation
Manufacturer SRN: KR-MF-000018672
UDI-DI: 08809537078412
Basic UDI-DI: 880953707A20656V
Reference: A-2065-1
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:59

Manufacturer products Authorised representative products Authorised representative actors View details

ExiStation™ FA DNA/RNA Kit (V3)

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: BIONEER Corporation
Manufacturer SRN: KR-MF-000018672
UDI-DI: 08809537078733
Basic UDI-DI: 880935717K4815BP
Reference: K-4815
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:59

Manufacturer products Authorised representative products Authorised representative actors View details

ExiStation™ FA DNA/RNA Kit (V2)

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: BIONEER Corporation
Manufacturer SRN: KR-MF-000018672
UDI-DI: 08809537078603
Basic UDI-DI: 880953707K4814BG
Reference: K-4814
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:59

Manufacturer products Authorised representative products Authorised representative actors View details

ExiStation™ FA 96

ExiStation™ FA 96/384

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: BIONEER Corporation
Manufacturer SRN: KR-MF-000018672
UDI-DI: 08809537078030
Basic UDI-DI: 880953707A25001ZB
Reference: A-2500-1
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:59

Manufacturer products Authorised representative products Authorised representative actors View details

AccuPower® SARS-CoV-2 Real-Time RT-PCR Kit

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: BIONEER Corporation
Manufacturer SRN: KR-MF-000018672
UDI-DI: 08809537077866
Basic UDI-DI: 880953707NCVM21111JH
Reference: NCVM2-1111
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:58

Manufacturer products Authorised representative products Authorised representative actors View details

IRON-qPCR™ RV Kit

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: BIONEER Corporation
Manufacturer SRN: KR-MF-000018672
UDI-DI: 08809537072533
Basic UDI-DI: 880953707QRV1113YY
Reference: QRV-1113
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:58

Manufacturer products Authorised representative products Authorised representative actors View details

IRON-qPCR™

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: BIONEER Corporation
Manufacturer SRN: KR-MF-000018672
UDI-DI: 08809537070744
Basic UDI-DI: 880953707A26006X
Reference: A-2600
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:58

Manufacturer products Authorised representative products Authorised representative actors View details

ExiPrep™96 Lite

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: BIONEER Corporation
Manufacturer SRN: KR-MF-000018672
UDI-DI: 08809537070188
Basic UDI-DI: 880953707A52507F
Reference: A-5250
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:58

Manufacturer products Authorised representative products Authorised representative actors View details

ExiPrep™16 Dx

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: BIONEER Corporation
Manufacturer SRN: KR-MF-000018672
UDI-DI: 08809537070065
Basic UDI-DI: 880953707A505075
Reference: A-5050
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:58

Manufacturer products Authorised representative products Authorised representative actors View details

ExiPrep™48 Dx

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: BIONEER Corporation
Manufacturer SRN: KR-MF-000018672
UDI-DI: 08809537070058
Basic UDI-DI: 880953707A51507A
Reference: A-5150
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:58

Manufacturer products Authorised representative products Authorised representative actors View details

Exicycler™ 96

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: BIONEER Corporation
Manufacturer SRN: KR-MF-000018672
UDI-DI: 08809537070034
Basic UDI-DI: 880953707A20601Z6
Reference: A-2060-1
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:58

Manufacturer products Authorised representative products Authorised representative actors View details

ExiPrep™ 96 Genomic DNA Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: BIONEER Corporation
Manufacturer SRN: KR-MF-000018672
UDI-DI: 08809357179870
Basic UDI-DI: 880953707K4611AY
Reference: K-4611
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:56

Manufacturer products Authorised representative products Authorised representative actors View details

MagListo™ 5M Viral DNA/RNA Extraction Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: BIONEER Corporation
Manufacturer SRN: KR-MF-000018672
UDI-DI: 08809357179498
Basic UDI-DI: 880953707K3617B5
Reference: K-3617
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:56

Manufacturer products Authorised representative products Authorised representative actors View details

ExiPrep™ 96 Viral DNA/RNA Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: BIONEER Corporation
Manufacturer SRN: KR-MF-000018672
UDI-DI: 08809357179481
Basic UDI-DI: 880953707K4614B6
Reference: K-4614
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:56

Manufacturer products Authorised representative products Authorised representative actors View details

ExiPrep ™ 48 Viral RNA Kit

ExiPrep™48 Viral RNA Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: BIONEER Corporation
Manufacturer SRN: KR-MF-000018672
UDI-DI: 08809357178316
Basic UDI-DI: 880953707K4573BH
Reference: K-4573
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:56

Manufacturer products Authorised representative products Authorised representative actors View details

ExiPrep™ 48 Viral DNA/RNA Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: BIONEER Corporation
Manufacturer SRN: KR-MF-000018672
UDI-DI: 08809357178309
Basic UDI-DI: 880953707K4571BD
Reference: K-4571
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:56

Manufacturer products Authorised representative products Authorised representative actors View details

ExiPrep™ 48 Genomic DNA Kit

ExiPrep™48 Genomic DNA Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: BIONEER Corporation
Manufacturer SRN: KR-MF-000018672
UDI-DI: 08809357178446
Basic UDI-DI: 880953707K4574BK
Reference: K-4574
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:56

Manufacturer products Authorised representative products Authorised representative actors View details