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D-5539154038ED-209T42K

ED-209

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: OACP IE LTD
Manufacturer SRN: IE-MF-000003506
UDI-DI: D-5539154038ED-209T42K
Basic UDI-DI: B-5539154038ED-209T42K
Reference: ED-209
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 17.07.2026 02:47

Manufacturer products View details

50610078000366

Congenica Rare Disease

IVD generalIVDDOn the marketProfessional testing

Manufacturer: Congenica Ltd
Manufacturer SRN: GB-MF-000026168
UDI-DI: 50610078000366
Basic UDI-DI: B-50610078000366
Reference: 101
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Ireland
Authorised representative: Acorn Regulatory Consultancy Services Ltd
Last updated: 17.07.2026 02:33

Manufacturer products Authorised representative products Authorised representative actors View details

Veros COVID-19

CD0004-SP-107

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Sense Biodetection Limited
Manufacturer SRN: GB-MF-000022999
UDI-DI: 50608178000140
Basic UDI-DI: B-50608178000140
Reference: CD0004-SP-107
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: Ireland
Authorised representative: Emergo Europe B.V.
Last updated: 17.07.2026 02:23

Manufacturer products Authorised representative products Authorised representative actors View details

08885019710094

800800

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: AITbiotech Pte Ltd
Manufacturer SRN: SG-MF-000003510
UDI-DI: 08885019710094
Basic UDI-DI: 888501971800800WU
Reference: 800800
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 16.07.2026 12:51

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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