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ExiPrep™ Dx Mycobacteria Genomic DNA Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: BIONEER Corporation
Manufacturer SRN: KR-MF-000018672
UDI-DI: 08809357174233
Basic UDI-DI: 880953707K4418B4
Reference: K-4418
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 20:55

Manufacturer products Authorised representative products Authorised representative actors View details

ExiPrep™ Dx Bacteria Genomic DNA Kit

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: BIONEER Corporation
Manufacturer SRN: KR-MF-000018672
UDI-DI: 08809357174219
Basic UDI-DI: 880953707K4414AU
Reference: K-4414
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 20:55

Manufacturer products Authorised representative products Authorised representative actors View details

ExiPrep™ Dx Blood Genomic DNA Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: BIONEER Corporation
Manufacturer SRN: KR-MF-000018672
UDI-DI: 08809357174196
Basic UDI-DI: 880953707K4411AN
Reference: K-4411
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 20:55

Manufacturer products Authorised representative products Authorised representative actors View details

ExiPrep™ Dx Viral DNA Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: BIONEER Corporation
Manufacturer SRN: KR-MF-000018672
UDI-DI: 08809357174172
Basic UDI-DI: 880953707K4472BA
Reference: K-4472
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 20:55

Manufacturer products Authorised representative products Authorised representative actors View details

ExiPrep™ Dx Viral DNA/RNA Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: BIONEER Corporation
Manufacturer SRN: KR-MF-000018672
UDI-DI: 08809357174158
Basic UDI-DI: 880953707K4471B8
Reference: K-4471
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 20:55

Manufacturer products Authorised representative products Authorised representative actors View details

ExiPrep™ Dx Viral RNA Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: BIONEER Corporation
Manufacturer SRN: KR-MF-000018672
UDI-DI: 08809357174134
Basic UDI-DI: 880953707K4473BC
Reference: K-4473
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 20:55

Manufacturer products Authorised representative products Authorised representative actors View details

AccuPrep® Dx Viral RNA Extraction Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: BIONEER Corporation
Manufacturer SRN: KR-MF-000018672
UDI-DI: 08809357173526
Basic UDI-DI: 880953707K3033M76
Reference: K-3033M
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 20:55

Manufacturer products Authorised representative products Authorised representative actors View details

ExiPrep™ 48 SF Mycobacteria Genomic DNA Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: BIONEER Corporation
Manufacturer SRN: KR-MF-000018672
UDI-DI: 08800242990143
Basic UDI-DI: 880024299K45793S
Reference: K-4579
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 20:36

Manufacturer products Authorised representative products Authorised representative actors View details

ExiPrep™ Dx SF Mycobacteria Genomic DNA Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: BIONEER Corporation
Manufacturer SRN: KR-MF-000018672
UDI-DI: 08800242990235
Basic UDI-DI: 880024299K44793M
Reference: K-4479
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 20:36

Manufacturer products Authorised representative products Authorised representative actors View details

ExiPrep™ 48 SF Genomic DNA Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: BIONEER Corporation
Manufacturer SRN: KR-MF-000018672
UDI-DI: 08800242990129
Basic UDI-DI: 880024299K45773N
Reference: K-4577
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 20:36

Manufacturer products Authorised representative products Authorised representative actors View details

ExiPrep™ 48 SF Viral DNA/RNA Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: BIONEER Corporation
Manufacturer SRN: KR-MF-000018672
UDI-DI: 08800242990136
Basic UDI-DI: 880024299K45783Q
Reference: K-4578
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 20:36

Manufacturer products Authorised representative products Authorised representative actors View details

08800151200142

W73052-100

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Wizbiosolutions Inc.
Manufacturer SRN: KR-MF-000024896
UDI-DI: 08800151200142
Basic UDI-DI: 88001512W73052-1002Q
Reference: W73052-100
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
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

08800118520511

Media:DirectTM Extraction Buffer

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Genesystem Co., Ltd.
Manufacturer SRN: KR-MF-000022998
UDI-DI: 08800118520511
Basic UDI-DI: 88001185HR0020513L
Reference: 9799140106
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Austria
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:33

Manufacturer products Authorised representative products Authorised representative actors View details

08800118520412

Swab:DirectTM Extraction Kit, Swab:DirectTM Extraction Kit (2mL) / Trans:DirectTM Extraction Kit

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

Manufacturer: Genesystem Co., Ltd.
Manufacturer SRN: KR-MF-000022998
UDI-DI: 08800118520412
Basic UDI-DI: 88001185HR0020413H
Reference: 9799140105
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 20:33

Manufacturer products Authorised representative products Authorised representative actors View details

PaxView DNA Extraction Kit

V0101

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: PaxGenBio Co., Ltd.
Manufacturer SRN: KR-MF-000024696
UDI-DI: 08800097500085
Basic UDI-DI: 880009750008D7
Reference: V0101F
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 20:29

Manufacturer products Authorised representative products Authorised representative actors View details

PowerPrep™ Pathogen NA Extraction Kit EXP

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: KogeneBiotech Co., Ltd.
Manufacturer SRN: KR-MF-000045858
UDI-DI: 08800056300060
Basic UDI-DI: 88000563E00195H
Reference: E0019
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Czechia
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 20:26

Manufacturer products Authorised representative products Authorised representative actors View details

PowerPrep™ Whole blood NA Extraction Kit EXP

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: KogeneBiotech Co., Ltd.
Manufacturer SRN: KR-MF-000045858
UDI-DI: 08800056300046
Basic UDI-DI: 88000563E00185F
Reference: E0018
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Czechia
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 20:26

Manufacturer products Authorised representative products Authorised representative actors View details

PowerPrep™ Viral NA Extraction Kit EXP

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: KogeneBiotech Co., Ltd.
Manufacturer SRN: KR-MF-000045858
UDI-DI: 08800056300022
Basic UDI-DI: 88000563E00175D
Reference: E0017
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Czechia
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 20:26

Manufacturer products Authorised representative products Authorised representative actors View details

PowerPrep™ Viral DNA/RNA Extraction Kit Ver.1.0

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: KogeneBiotech Co., Ltd.
Manufacturer SRN: KR-MF-000045858
UDI-DI: 08800056300015
Basic UDI-DI: 88000563E00165B
Reference: E0016
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Czechia
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 20:26

Manufacturer products Authorised representative products Authorised representative actors View details

CleanNGS Dx

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: CleanNA B.V.
Manufacturer SRN: NL-MF-000022870
UDI-DI: 08720299808744
Basic UDI-DI: 87202998087CNGS77
Reference: CNGS-0500CE
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Netherlands
Authorised representative: -
Last updated: 03.07.2026 19:53

Manufacturer products View details