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495 device results listed.

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LOAA-M Powerbox System

LAM306-01

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: OPTOLANE Technologies Inc.
Manufacturer SRN: KR-MF-000026042
UDI-DI: 08809740940124
Basic UDI-DI: 8809740943M0069J
Reference: LAM306-01
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Belgium
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 21:00

Manufacturer products Authorised representative products Authorised representative actors View details

08809740940063

LOAA-M Console

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: OPTOLANE Technologies Inc.
Manufacturer SRN: KR-MF-000026042
UDI-DI: 08809740940063
Basic UDI-DI: 880974094LAM303HV
Reference: LAM303-01
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Belgium
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:59

Manufacturer products Authorised representative products Authorised representative actors View details

LOAA Analyzer

ONPOINT

IVD Class AIVDR 2017/746On the marketInstrumentKitProfessional testing

Manufacturer: OPTOLANE Technologies Inc.
Manufacturer SRN: KR-MF-000026042
UDI-DI: 08809740940025
Basic UDI-DI: 880974094LAM301HR
Reference: LAM301-01
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Belgium
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 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

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

08809054870391

AutoXT Total gDNA Kit

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

Manufacturer: iNtRON Biotechnology
Manufacturer SRN: KR-MF-000036507
UDI-DI: 08809054870391
Basic UDI-DI: 88090548717188-96VF
Reference: 17188-96
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Croatia
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 20:44

Manufacturer products Authorised representative products Authorised representative actors View details

08809054870384

AutoXT Total gDNA Kit

IVD Class AIVDR 2017/746On the marketDirect markingKitReagentSingle use

Manufacturer: iNtRON Biotechnology
Manufacturer SRN: KR-MF-000036507
UDI-DI: 08809054870384
Basic UDI-DI: 88090548717188-48V4
Reference: 17188-48
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Croatia
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 20:44

Manufacturer products Authorised representative products Authorised representative actors View details

08800204300690

RADI PCR

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: KH Medical Co., Ltd.
Manufacturer SRN: KR-MF-000017883
UDI-DI: 08800204300690
Basic UDI-DI: 88002043RADIPCRHC
Reference: KM005
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 20:35

Manufacturer products Authorised representative products Authorised representative actors View details

08800204300096

RADICHAMP

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: KH Medical Co., Ltd.
Manufacturer SRN: KR-MF-000017883
UDI-DI: 08800204300096
Basic UDI-DI: 88002043RADICHAMP25
Reference: KM002
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 20:34

Manufacturer products Authorised representative products Authorised representative actors View details

08800151200272

CL2016

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Wizbiosolutions Inc.
Manufacturer SRN: KR-MF-000024896
UDI-DI: 08800151200272
Basic UDI-DI: 88001512CL2016Z8
Reference: CL2016
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Finland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 03.07.2026 20:34

Manufacturer products Authorised representative products Authorised representative actors View details

08800151200241

CL0001P1

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Wizbiosolutions Inc.
Manufacturer SRN: KR-MF-000024896
UDI-DI: 08800151200241
Basic UDI-DI: 88001512CL0001P1SV
Reference: CL0001P1
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Finland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 03.07.2026 20:34

Manufacturer products Authorised representative products Authorised representative actors View details

08800151200067

CL0016

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Wizbiosolutions Inc.
Manufacturer SRN: KR-MF-000024896
UDI-DI: 08800151200067
Basic UDI-DI: 88001512CL0016YS
Reference: CL0016
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Finland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 03.07.2026 20:34

Manufacturer products Authorised representative products Authorised representative actors View details

isoQuarkM4

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testing

Manufacturer: RevoSketch Inc.
Manufacturer SRN: KR-MF-000037550
UDI-DI: 08800122900064
Basic UDI-DI: 88001229AIM4K2
Reference: RS-AIM4-E001
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 03.07.2026 20:33

Manufacturer products Authorised representative products Authorised representative actors View details

SS-7010

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testing

Manufacturer: RevoSketch Inc.
Manufacturer SRN: KR-MF-000037550
UDI-DI: 08800122900019
Basic UDI-DI: 88001229ASS7MC
Reference: RS-ASS7-E001
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 03.07.2026 20:33

Manufacturer products Authorised representative products Authorised representative actors View details

isoQuarkF2

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testing

Manufacturer: RevoSketch Inc.
Manufacturer SRN: KR-MF-000037550
UDI-DI: 08800122900002
Basic UDI-DI: 88001229AIF2J9
Reference: RS-AIF2-E001
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 03.07.2026 20:33

Manufacturer products Authorised representative products Authorised representative actors View details