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NEXgen

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: ADALTIS SRL
Manufacturer SRN: IT-MF-000028990
UDI-DI: ++M521NXGXK
Basic UDI-DI: B-++M521NXGXK
Reference: NXG
EMDN: W0201020103
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h)
First on market country: Romania
Authorised representative: -
Last updated: 04.08.2026 23:02

Manufacturer products View details

BIO-FLASH Waste Bottle

BIO-FLASH

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Biokit S.A.
Manufacturer SRN: ES-MF-000002406
UDI-DI: 08436003070658
Basic UDI-DI: 84269506397259T
Reference: 3410-0827
EMDN: W0201020180
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES
First on market country: Spain
Authorised representative: -
Last updated: 04.08.2026 22:39

Manufacturer products View details

Automated CLEIA system

DNK-MiniCL8

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Chengdu Illumaxbio Technology Co.,LTD
Manufacturer SRN: CN-MF-000026407
UDI-DI: 06980222380187
Basic UDI-DI: 697529264012MV
Reference: E105
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: France
Authorised representative: MedNet EC-REP GmbH
Last updated: 04.08.2026 22:25

Manufacturer products Authorised representative products Authorised representative actors View details

Automated CLEIA system

DNK-MiniCL16

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Chengdu Illumaxbio Technology Co.,LTD
Manufacturer SRN: CN-MF-000026407
UDI-DI: 06980222380170
Basic UDI-DI: 697529264011MT
Reference: E106
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: France
Authorised representative: MedNet EC-REP GmbH
Last updated: 04.08.2026 22:25

Manufacturer products Authorised representative products Authorised representative actors View details

Automated CLEIA system

lumilite8s

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Chengdu Illumaxbio Technology Co.,LTD
Manufacturer SRN: CN-MF-000026407
UDI-DI: 06980222380033
Basic UDI-DI: 697529264003MU
Reference: E103
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: France
Authorised representative: MedNet EC-REP GmbH
Last updated: 04.08.2026 22:25

Manufacturer products Authorised representative products Authorised representative actors View details

Microplate Reader

Please see UDI-DI for detail

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 08887581001730
Basic UDI-DI: 69449040MYYQ-0104******89
Reference: MR-96A
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 04.08.2026 22:10

Manufacturer products Authorised representative products Authorised representative actors View details

Hidex GammaDx

425-604

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hidex Oy
Manufacturer SRN: FI-MF-000056616
UDI-DI: 06429830313908
Basic UDI-DI: 64298303139AMGZP
Reference: 425-604
EMDN: W0201020203
EMDN description: GAMMA COUNTERS
First on market country: Finland
Authorised representative: -
Last updated: 04.08.2026 21:59

Manufacturer products View details

TruVue

TV600

IVD Class AIVDR 2017/746On the marketInstrumentNear-patient testingProfessional testing

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763938
Basic UDI-DI: 5065023763TV600013P
Reference: TV60001
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: France
Authorised representative: SUNGO Europe B.V.
Last updated: 04.08.2026 21:40

Manufacturer products Authorised representative products Authorised representative actors View details

BlueDiver Instrument 2

INSTRUMENT II

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023685044
Basic UDI-DI: 5425023685044W7
Reference: BLUEDIVER2
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Belgium
Authorised representative: -
Last updated: 04.08.2026 21:39

Manufacturer products View details

HM-JACK Sample Cup

HM-JACKarcⅡ

IVD Class AIVDR 2017/746On the marketInstrumentKitProfessional testing

Manufacturer: Canon Medical Diagnostics Corporation
Manufacturer SRN: JP-MF-000020364
UDI-DI: 04987295531517
Basic UDI-DI: 4987295BU002ZT
Reference: 53151
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Spain
Authorised representative: Obelis s.a.
Last updated: 04.08.2026 21:33

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM 1600 Analyzer

IVDR_67_TTN_DUB-C_A_INST_1600 Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414650623
Basic UDI-DI: 0405686901509VM
Reference: 11764888
EMDN: W0201020103
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h)
First on market country: Belgium
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 04.08.2026 20:55

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM 1300 Analyzer

IVDR_67_TTN_DUB-C_A_INST_1300 Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414650579
Basic UDI-DI: 0405686901508VK
Reference: 11764765
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Belgium
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 04.08.2026 20:55

Manufacturer products Authorised representative products Authorised representative actors View details

06930317800892

WD240

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd.
Manufacturer SRN: CN-MF-000001133
UDI-DI: 06930317800892
Basic UDI-DI: B-06930317800892
Reference: WD240
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 12:34

Manufacturer products Authorised representative products Authorised representative actors View details

skyla

HI-P01

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Skyla Corporation Hsinchu Science Park Branch
Manufacturer SRN: TW-MF-000007751
UDI-DI: 04719878650021
Basic UDI-DI: 471987865801-000VN
Reference: 801-000
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.08.2026 09:40

Manufacturer products Authorised representative products Authorised representative actors View details

GastroSoft

IVD generalIVDDOn the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Biohit Oyj
Manufacturer SRN: FI-MF-000014642
UDI-DI: 06419587740195
Basic UDI-DI: B-06419587740195
Reference: 740193
EMDN: W0201020292
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - IVD MEDICAL DEVICE SOFTWAE
First on market country: Finland
Authorised representative: -
Last updated: 03.08.2026 03:54

Manufacturer products View details

09120122921708

MAX 9k

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: MacroArray Diagnostics
Manufacturer SRN: AT-MF-000030541
UDI-DI: 09120122921708
Basic UDI-DI: 91201229217K5
Reference: 17-0000-01
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Austria
Authorised representative: -
Last updated: 01.08.2026 00:41

Manufacturer products View details

09120122921609

MAX 45k

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: MacroArray Diagnostics
Manufacturer SRN: AT-MF-000030541
UDI-DI: 09120122921609
Basic UDI-DI: 91201229216K3
Reference: 16-0000-01
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Austria
Authorised representative: -
Last updated: 01.08.2026 00:41

Manufacturer products View details

09120122921104

ImageXplorer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: MacroArray Diagnostics
Manufacturer SRN: AT-MF-000030541
UDI-DI: 09120122921104
Basic UDI-DI: 91201229211JR
Reference: 11-0000-01
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Austria
Authorised representative: -
Last updated: 01.08.2026 00:41

Manufacturer products View details

HYDROFLEX PLUS

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Tecan Austria GmbH
Manufacturer SRN: AT-MF-000020241
UDI-DI: 09120052071160
Basic UDI-DI: 912005207IVS10080001AP4
Reference: 30190374
EMDN: W0201020299
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - OTHER
First on market country: Austria
Authorised representative: -
Last updated: 01.08.2026 00:34

Manufacturer products View details

INFINITE F50 PLUS

Infinite F50 Plus

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Tecan Austria GmbH
Manufacturer SRN: AT-MF-000020241
UDI-DI: 09120052071146
Basic UDI-DI: 912005207IVS10080000ANZ
Reference: 30183570
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Austria
Authorised representative: -
Last updated: 01.08.2026 00:34

Manufacturer products View details