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01.08.2026 01:12

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122 device results listed.

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06974149860044

ONEblot Dx

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentSingle use

Manufacturer: Aperbio Technologies (Suzhou) Co., Ltd
Manufacturer SRN: CN-MF-000045149
UDI-DI: 06974149860044
Basic UDI-DI: 697414986ONEblotDxC6
Reference: H511001
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 02.07.2026 15:28

Manufacturer products Authorised representative products Authorised representative actors View details

06974149860020

XW Dx

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentSingle use

Manufacturer: Aperbio Technologies (Suzhou) Co., Ltd
Manufacturer SRN: CN-MF-000045149
UDI-DI: 06974149860020
Basic UDI-DI: 697414986XW3XH
Reference: H631104
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 02.07.2026 15:28

Manufacturer products Authorised representative products Authorised representative actors View details

06973609151135

ADC CH196

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Yantai Addcare Bio-Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000018409
UDI-DI: 06973609151135
Basic UDI-DI: 697360915113KL
Reference: （01）6973609151135（11）210110（21）5B62021001
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Romania
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 02.07.2026 14:49

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06973609151128

Nexor 96

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Yantai Addcare Bio-Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000018409
UDI-DI: 06973609151128
Basic UDI-DI: 697360915112KJ
Reference: （01）6973609151128（11）200815（21）5B22020189
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Romania
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 02.07.2026 14:49

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06973609151111

Nexor 32

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Yantai Addcare Bio-Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000018409
UDI-DI: 06973609151111
Basic UDI-DI: 697360915111KG
Reference: （01）6973609151111（11）210106（21）5B12021001
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Denmark
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 02.07.2026 14:49

Manufacturer products Authorised representative products Authorised representative actors View details

06973609150565

NA4424

IVD Class AIVDR 2017/746Not intended for EU marketDirect markingInstrumentProfessional testing

Manufacturer: Yantai Addcare Bio-Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000018409
UDI-DI: 06973609150565
Basic UDI-DI: 697360915056KZ
Reference: （01）6973609150565（11）210103（21）5562021001
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Austria
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 02.07.2026 14:49

Manufacturer products Authorised representative products Authorised representative actors View details

06973609150183

Nexor 32M

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Yantai Addcare Bio-Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000018409
UDI-DI: 06973609150183
Basic UDI-DI: 697360915018KR
Reference: （01）6973609150183（11）210105（21）5B92021001
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Ireland
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 02.07.2026 14:49

Manufacturer products Authorised representative products Authorised representative actors View details

Full Automatic Nucleic Acid Extractor

HH-6160

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testingSingle use

Manufacturer: Shenzhen Huisong Technology Development Co., Ltd
Manufacturer SRN: CN-MF-000032903
UDI-DI: 06973368211255
Basic UDI-DI: 697336821HH003DM
Reference: 9008
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Spain
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 14:32

Manufacturer products Authorised representative products Authorised representative actors View details

Real-time PCR System

STC-96A PLUS, STC-96A

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Jiangsu Bioperfectus Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000014691
UDI-DI: 06973342000257
Basic UDI-DI: 697334200STC96AHW
Reference: STC-96A PLUS
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 14:30

Manufacturer products Authorised representative products Authorised representative actors View details

chemagic Prime Jr-D

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Wallac Oy
Manufacturer SRN: FI-MF-000022620
UDI-DI: 06438147376209
Basic UDI-DI: 6438147chemagic_PrJr3L
Reference: 2029-0010
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:04

Manufacturer products View details

chemagic 360-D

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Wallac Oy
Manufacturer SRN: FI-MF-000022620
UDI-DI: 06438147356706
Basic UDI-DI: 6438147chemagic_360-DZ2
Reference: 2024-0010
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:04

Manufacturer products View details

chemagic Prepito-D

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Wallac Oy
Manufacturer SRN: FI-MF-000022620
UDI-DI: 06438147332205
Basic UDI-DI: 6438147chemagic_Prep5J
Reference: 2022-0020
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:04

Manufacturer products View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

GridION Sequencing Device Dx1 RGL

GridION Dx

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testingReagent

Manufacturer: Oxford Nanopore Diagnostics Limited
Manufacturer SRN: UK-MF-000046755
UDI-DI: 05056793800001
Basic UDI-DI: 50567938OND-GRD-Dx1-RGLKR
Reference: OND-GRD-DX1-RGL
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Netherlands
Authorised representative: MedEnvoy Global BV
Last updated: 02.07.2026 02:01

Manufacturer products Authorised representative products Authorised representative actors View details

04262367270007

LabDisk-Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Dermagnostix GmbH
Manufacturer SRN: DE-MF-000025137
UDI-DI: 04262367270007
Basic UDI-DI: 426236727TD-AZ001GB
Reference: ESDR12-MB-1000
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 23:27

Manufacturer products View details

careHPV Test Luminometer

IVD Class AIVDR 2017/746No longer on the marketDirect markingInstrumentProfessional testing

Manufacturer: QIAGEN GmbH
Manufacturer SRN: DE-MF-000004949
UDI-DI: 04053228048015
Basic UDI-DI: 4053228ICARELUM0000000128
Reference: 9001773
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: -
Authorised representative: -
Last updated: 01.07.2026 19:23

Manufacturer products View details

DML 3000

digene Microplate Luminometer 3000 (DML 3000)

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: QIAGEN Sciences LLC
Manufacturer SRN: US-MF-000014502
UDI-DI: 04053228010777
Basic UDI-DI: 4053228IHC2DML0000000017V
Reference: 5000-00031
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Germany
Authorised representative: QIAGEN GmbH
Last updated: 01.07.2026 19:22

Manufacturer products Authorised representative products Authorised representative actors View details

GTQ-Cycler 96

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hain Lifescience GmbH
Manufacturer SRN: DE-MF-000008606
UDI-DI: 04049055003860
Basic UDI-DI: 40490550300001083UM
Reference: 1876820
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:48

Manufacturer products View details

FluoroCycler® XT

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hain Lifescience GmbH
Manufacturer SRN: DE-MF-000008606
UDI-DI: 04049055003396
Basic UDI-DI: 40490550300001072UG
Reference: 2017
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:47

Manufacturer products View details

FluoroCycler® 12

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hain Lifescience GmbH
Manufacturer SRN: DE-MF-000008606
UDI-DI: 04049055002993
Basic UDI-DI: 40490550300001070UC
Reference: 7027001
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:47

Manufacturer products View details