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21.09.2026 19:21

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11 device results listed.

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Benchbot® 4800

4800

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: EntroGen, Inc.
Manufacturer SRN: US-MF-000022721
UDI-DI: 05060536830750
Basic UDI-DI: 506053683BBOT01ZU
Reference: BBOT4800
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Italy
Authorised representative: TANJA TOPOVSEK S.P.
Last updated: 31.07.2026 08:48

Manufacturer products Authorised representative products Authorised representative actors View details

Bisulfite Conversion Kit

Bisulfite Conversion Kit

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: EntroGen, Inc.
Manufacturer SRN: US-MF-000022721
UDI-DI: 05060536830675
Basic UDI-DI: 506053683BCK055
Reference: BCK-RT50
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: Slovenia
Authorised representative: TANJA TOPOVSEK S.P.
Last updated: 31.07.2026 08:48

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pureNA® Genomic DNA Isolation Kit

pureNA® Genomic DNA Isolation Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: EntroGen, Inc.
Manufacturer SRN: US-MF-000022721
UDI-DI: 05060536830583
Basic UDI-DI: 506053683GDNA01ZD
Reference: GDNA-50
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: Greece
Authorised representative: TANJA TOPOVSEK S.P.
Last updated: 31.07.2026 08:47

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pureNA® Cell-Free DNA Isolation Kit

pureNA® Cell-Free DNA Isolation Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: EntroGen, Inc.
Manufacturer SRN: US-MF-000022721
UDI-DI: 05060536830576
Basic UDI-DI: 506053683CFDNA1ZS
Reference: CFDNA-50
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: Czechia
Authorised representative: TANJA TOPOVSEK S.P.
Last updated: 31.07.2026 08:47

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Library Quantification for Illumina®

Library Quantification for Illumina®

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: EntroGen, Inc.
Manufacturer SRN: US-MF-000022721
UDI-DI: 05060536830415
Basic UDI-DI: 506053683LIBQ0154
Reference: LIBQ-NGS
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Poland
Authorised representative: TANJA TOPOVSEK S.P.
Last updated: 31.07.2026 08:47

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Internal Quality Control Assay

Internal Quality Control Assay

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: EntroGen, Inc.
Manufacturer SRN: US-MF-000022721
UDI-DI: 05060536830262
Basic UDI-DI: 506053683IQCA014C
Reference: IQCA-RT50
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Northern Ireland
Authorised representative: TANJA TOPOVSEK S.P.
Last updated: 31.07.2026 08:47

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NGS Library Prep Kit For Illumina®

NGS Library Prep Kit For Illumina®

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: EntroGen, Inc.
Manufacturer SRN: US-MF-000022721
UDI-DI: 05060536830712
Basic UDI-DI: 506053683LIG001Z4
Reference: NGS-LIG
EMDN: W0599
EMDN description: IVD GENERAL USE CONSUMABLE DEVICES - OTHER
First on market country: Greece
Authorised representative: TANJA TOPOVSEK S.P.
Last updated: 02.07.2026 02:23

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NGS Adapter Kit for Illumina®

NGS Adapter Kit for Illumina®

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: EntroGen, Inc.
Manufacturer SRN: US-MF-000022721
UDI-DI: 05060536830705
Basic UDI-DI: 506053683ADP001UV
Reference: NGS-ADP
EMDN: W0599
EMDN description: IVD GENERAL USE CONSUMABLE DEVICES - OTHER
First on market country: Greece
Authorised representative: TANJA TOPOVSEK S.P.
Last updated: 02.07.2026 02:23

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Library Prep Purification Kit

Library Prep Purification Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: EntroGen, Inc.
Manufacturer SRN: US-MF-000022721
UDI-DI: 05060536830682
Basic UDI-DI: 506053683BDS001VX
Reference: NGS-BDS
EMDN: W0599
EMDN description: IVD GENERAL USE CONSUMABLE DEVICES - OTHER
First on market country: Greece
Authorised representative: TANJA TOPOVSEK S.P.
Last updated: 02.07.2026 02:23

Manufacturer products Authorised representative products Authorised representative actors View details

DNA Fragmentation Quantification Assay

DNA Fragmentation Quantification Assay

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: EntroGen, Inc.
Manufacturer SRN: US-MF-000022721
UDI-DI: 05060536830231
Basic UDI-DI: 506053683FQA001Y4
Reference: FQA-RT40
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Poland
Authorised representative: TANJA TOPOVSEK S.P.
Last updated: 02.07.2026 02:23

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BRAF Codon 600 Mutation Analysis Kit II

-

IVD generalNot specifiedOn the market

Manufacturer: EntroGen, Inc.
Manufacturer SRN: US-MF-000022721
UDI-DI: 05060536830101
Basic UDI-DI: B-05060536830101
Reference: BRAFX-RT64
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Slovenia
Authorised representative: TANJA TOPOVSEK S.P.
Last updated: 20.06.2026 00:01

Manufacturer products Authorised representative products Authorised representative actors View details