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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

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

ExiPrep™ Dx Blood Viral DNA Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: BIONEER Corporation
Manufacturer SRN: KR-MF-000018672
UDI-DI: 08809357174400
Basic UDI-DI: 880953707K4474BE
Reference: K-4474
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 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