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08809975891017

HysenD30H

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hysen Biotech.Inc
Manufacturer SRN: KR-MF-000048224
UDI-DI: 08809975891017
Basic UDI-DI: 88099758902007000284
Reference: HysenD30H
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 16.07.2026 12:51

Manufacturer products Authorised representative products Authorised representative actors View details

08809975890034

HysenDx 200

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hysen Biotech.Inc
Manufacturer SRN: KR-MF-000048224
UDI-DI: 08809975890034
Basic UDI-DI: 88099758902007000182
Reference: HysenDx 200
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 16.07.2026 12:51

Manufacturer products Authorised representative products Authorised representative actors View details

SGRT

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240109038
Basic UDI-DI: 924010SG73100KR
Reference: SG73100
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: 16.07.2026 12:50

Manufacturer products Authorised representative products Authorised representative actors View details

08809378689204

PANAMAX™ 16

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testingSingle use

Manufacturer: HLB PANAGENE
Manufacturer SRN: KR-MF-000042004
UDI-DI: 08809378689204
Basic UDI-DI: 88093786PNAE200ZR
Reference: PNAE-2001
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 16.07.2026 12:46

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08809378689174

PANAMAX™ 48

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testingSingle use

Manufacturer: HLB PANAGENE
Manufacturer SRN: KR-MF-000042004
UDI-DI: 08809378689174
Basic UDI-DI: 88093786PNAE100ZL
Reference: PNAE-1001
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Bulgaria
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 16.07.2026 12:45

Manufacturer products Authorised representative products Authorised representative actors View details

LQ Suite Droplet Analyzer

TAS-100-5MD

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: BioTNS Co., Ltd.
Manufacturer SRN: KR-MF-000026409
UDI-DI: 08800271570040
Basic UDI-DI: 8800271578800271570040C6
Reference: TAS-100-5MD
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Italy
Authorised representative: Advena Limited
Last updated: 16.07.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

Nucleic Acid Amplification Analyzer

AIMDX 1800

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hangzhou Zhunxin Biotechnology
Manufacturer SRN: CN-MF-000028333
UDI-DI: 06976037880004
Basic UDI-DI: 697603788AIMDX1800R4
Reference: INS-01
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 16.07.2026 11:19

Manufacturer products Authorised representative products Authorised representative actors View details

06974884775016

Rhodonite

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Xi'an Tianlong Science and Technology Co., Ltd.
Manufacturer SRN: CN-MF-000001079
UDI-DI: 06974884775016
Basic UDI-DI: 697488477TLH021YV
Reference: Y005H-RG-01
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 16.07.2026 11:13

Manufacturer products Authorised representative products Authorised representative actors View details

Automated Nucleic Acid Purification System

PureStar-32

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06970341686871
Basic UDI-DI: 6970341680120801HN
Reference: 0120801
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Netherlands
Authorised representative: Umedwings Netherlands B.V.
Last updated: 16.07.2026 10:57

Manufacturer products Authorised representative products Authorised representative actors View details

Real-time PCR instrument DTlite 4S1

Real-time PCR instrument DTlite

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: DNA-Technology, Research & Production, LLC
Manufacturer SRN: RU-MF-000028223
UDI-DI: 04660014360512
Basic UDI-DI: 466001436DA01ZL
Reference: O-DTLITE4S1-EU
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Bulgaria
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 09:30

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Real-time PCR instrument DTprime 5M1

Real-time PCR instrument DTprime

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: DNA-Technology, Research & Production, LLC
Manufacturer SRN: RU-MF-000028223
UDI-DI: 04660014360499
Basic UDI-DI: 466001436DA02ZN
Reference: O-DTPRIME5M1-EU
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Bulgaria
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 09:30

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BioArray Array Imaging System TM (AIS) 400D

400D

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: BioArray Solutions Ltd
Manufacturer SRN: US-MF-000022068
UDI-DI: 10888234102229
Basic UDI-DI: 088823479020016PM
Reference: 790-20016
EMDN: W02050201
EMDN description: MICRO-ARRAY ANALYSERS
First on market country: Germany
Authorised representative: IMMUCOR Medizinische Diagnostik GmbH
Last updated: 16.07.2026 07:44

Manufacturer products Authorised representative products Authorised representative actors View details

Alinity m

ALINITY M HIV-1 DBS ASF

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Abbott Molecular Inc.
Manufacturer SRN: US-MF-000017776
UDI-DI: 00884999051645
Basic UDI-DI: 0884999AMN0053WH
Reference: 08N45-04B
EMDN: W02050182
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - SOFTWARE ACCESSORIES
First on market country: Germany
Authorised representative: Abbott GmbH
Last updated: 16.07.2026 07:24

Manufacturer products Authorised representative products Authorised representative actors View details

00860010246221

NAE 2 PLUS

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Bifour Biotech Inc.
Manufacturer SRN: US-MF-000034957
UDI-DI: 00860010246221
Basic UDI-DI: 08600102462NucleicAcidVQ
Reference: NAE 2 PLUS
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 16.07.2026 06:53

Manufacturer products Authorised representative products Authorised representative actors View details

00860010246214

KadieCheck® Pro Max

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Bifour Biotech Inc.
Manufacturer SRN: US-MF-000034957
UDI-DI: 00860010246214
Basic UDI-DI: 08600102462PCRL9
Reference: KadieCheck® Pro Max
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 16.07.2026 06:53

Manufacturer products Authorised representative products Authorised representative actors View details

cobas® eplex system

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: GenMark Diagnostics
Manufacturer SRN: US-MF-000010772
UDI-DI: 00857167005382
Basic UDI-DI: 085716700510107545001KP
Reference: 10107545001
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:41

Manufacturer products Authorised representative products Authorised representative actors View details

ePlex Instrument

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: GenMark Diagnostics
Manufacturer SRN: US-MF-000010772
UDI-DI: 00857167005009
Basic UDI-DI: 0857167005RM0030017M
Reference: RM003001
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:41

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GeneChip™ Fluidics Station FS450Dx v.2

GeneChip™ System 3000Dx v.2 Instrument System

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Affymetrix, Inc.
Manufacturer SRN: US-MF-000028847
UDI-DI: 00856826006029
Basic UDI-DI: 0856826006000334CC
Reference: 00-0335 (00-0334)
EMDN: W02050201
EMDN description: MICRO-ARRAY ANALYSERS
First on market country: Netherlands
Authorised representative: Life Technologies Europe B.V.
Last updated: 16.07.2026 06:41

Manufacturer products Authorised representative products Authorised representative actors View details

BioArray Array Imaging System TM (AIS) 400D

400D

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: BioArray Solutions Ltd
Manufacturer SRN: US-MF-000022068
UDI-DI: 00850081948001
Basic UDI-DI: 08500819481WAY
Reference: 790-20016
EMDN: W02050201
EMDN description: MICRO-ARRAY ANALYSERS
First on market country: Germany
Authorised representative: IMMUCOR Medizinische Diagnostik GmbH
Last updated: 16.07.2026 06:31

Manufacturer products Authorised representative products Authorised representative actors View details

HighPrep PCR - DX (1000 mL)

Device for post-PCR and post-enzymatic reaction clean-up

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: MagBio Genomics, Inc.
Manufacturer SRN: US-MF-000038221
UDI-DI: 00850049735629
Basic UDI-DI: 0850049735AC-61000ET6
Reference: AC-61000E
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 16.07.2026 06:30

Manufacturer products Authorised representative products Authorised representative actors View details