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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

IsoAmplar

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133010471
Basic UDI-DI: 880613301047C4
Reference: FPRR043
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 20:38

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

08800204300010

RADIPREP

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: KH Medical Co., Ltd.
Manufacturer SRN: KR-MF-000017883
UDI-DI: 08800204300010
Basic UDI-DI: 88002043RADIPREPSD
Reference: KM001
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
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

08800118510505

UF-400

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Genesystem Co., Ltd.
Manufacturer SRN: KR-MF-000022998
UDI-DI: 08800118510505
Basic UDI-DI: 88001185HS0010503U
Reference: 1599100100
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 20:33

Manufacturer products Authorised representative products Authorised representative actors View details

08800118510413

UF-340

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Genesystem Co., Ltd.
Manufacturer SRN: KR-MF-000022998
UDI-DI: 08800118510413
Basic UDI-DI: 88001185HS0010413T
Reference: 1499100100
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 20:33

Manufacturer products Authorised representative products Authorised representative actors View details

08800118510307

UF-300 / UF-300P

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Genesystem Co., Ltd.
Manufacturer SRN: KR-MF-000022998
UDI-DI: 08800118510307
Basic UDI-DI: 88001185HS0010303N
Reference: 1399100200
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 20:33

Manufacturer products Authorised representative products Authorised representative actors View details

08800118510208

UF-150 / UF-150E / F-150

IVD Class AIVDR 2017/746No longer on the marketDirect markingInstrumentProfessional testing

Manufacturer: Genesystem Co., Ltd.
Manufacturer SRN: KR-MF-000022998
UDI-DI: 08800118510208
Basic UDI-DI: 88001185HS0010203K
Reference: 1199100101
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:33

Manufacturer products Authorised representative products Authorised representative actors View details

STANDARD™ M10 Module

M10-01S

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111706424
Basic UDI-DI: 88001117IPAA01MA01W2
Reference: M10-01M/11M1012
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:30

Manufacturer products Authorised representative products Authorised representative actors View details