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Automated Electrochemiluminescence (ECL) Immunoassay Analyzer

YnY3030

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Accucise Diagnostics Inc.
Manufacturer SRN: CN-MF-000045017
UDI-DI: 06975140162014
Basic UDI-DI: 697509050YnY3030BJ
Reference: A18111000002
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 18:10

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Chemiluminescence Immunoassay Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Biobase Diagnostic Technology (Shandong) Co., Ltd.
Manufacturer SRN: CN-MF-000025964
UDI-DI: 06974969982650
Basic UDI-DI: 697496998ZD002YF
Reference: ZD002
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 02.07.2026 17:48

Manufacturer products Authorised representative products Authorised representative actors View details

Macro & Micro-Test Fluorescence Reader

HWTS IF 100

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: 06974849366716
Basic UDI-DI: 697484936W0201020201DG
Reference: HWTS-EQ005
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 17:36

Manufacturer products Authorised representative products Authorised representative actors View details

ST-360 Microplate Reader

ST-360, ST-380, ST-960, ST-980

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shanghai Kehua Laboratory System Co., Ltd.
Manufacturer SRN: CN-MF-000017428
UDI-DI: 06974847812505
Basic UDI-DI: 697484781005Q8
Reference: ST-360
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 02.07.2026 17:36

Manufacturer products Authorised representative products Authorised representative actors View details

ST-36W Microplate Washer

ST-96W, ST-98W, ST-36W, ST-36WT, ST-36WF

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shanghai Kehua Laboratory System Co., Ltd.
Manufacturer SRN: CN-MF-000017428
UDI-DI: 06974847813007
Basic UDI-DI: 697484781006QA
Reference: ST-36W
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 02.07.2026 17:36

Manufacturer products Authorised representative products Authorised representative actors View details

V150 Automatic Chemiluminescence Immunoassay Analyzer

V150

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shanghai Kehua Laboratory System Co., Ltd.
Manufacturer SRN: CN-MF-000017428
UDI-DI: 06974847810532
Basic UDI-DI: 697484781008QE
Reference: V150
EMDN: W0201020103
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h)
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 02.07.2026 17:36

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Electrochemiluminescence Immunoassay Analyzer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Jiangsu Sunlant Bioengineering Co., Ltd.
Manufacturer SRN: CN-MF-000025940
UDI-DI: 06974795529999
Basic UDI-DI: 697479552SECAUL
Reference: SECA
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 02.07.2026 17:29

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Electrochemiluminescence Immunoassay Analyzer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Jiangsu Sunlant Bioengineering Co., Ltd.
Manufacturer SRN: CN-MF-000025940
UDI-DI: 06974795529982
Basic UDI-DI: 697479552SEBAUH
Reference: SEBA
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 02.07.2026 17:29

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Chemiluminescence Immunoassay Analyzer

GBI-MAP 800Plus

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Wuhan BGI Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000019026
UDI-DI: 06974742360064
Basic UDI-DI: 697474236006M2
Reference: GBI-MAP 800Plus
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 02.07.2026 17:26

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Chemiluminescence Immunoassay Analyzer

MAE-1200i

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Wuhan BGI Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000019026
UDI-DI: 06974742360033
Basic UDI-DI: 697474236003LU
Reference: MAE-1200i
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 02.07.2026 17:26

Manufacturer products Authorised representative products Authorised representative actors View details

KEYU Fluorescent Immunoassay Analyzer

FI-650S

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Zhuhai Keyu Biological Engineering Co., Ltd
Manufacturer SRN: CN-MF-000023195
UDI-DI: 06974735361481
Basic UDI-DI: 697473536KUA09PL
Reference: FI-650S
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 17:20

Manufacturer products Authorised representative products Authorised representative actors View details

KEYU Fluorescence Immunoassay Analyzer

Fluorescent Immunoassay Analyzer

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: Zhuhai Keyu Biological Engineering Co., Ltd
Manufacturer SRN: CN-MF-000023195
UDI-DI: 06974735361115
Basic UDI-DI: 697473536KUA06PE
Reference: FI-620
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Netherlands
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 17:20

Manufacturer products Authorised representative products Authorised representative actors View details

mLabs® Smart

m-20

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

Manufacturer: Micropoint Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000007991
UDI-DI: 06974703168098
Basic UDI-DI: 697470316m-20LF
Reference: m-20
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 02.07.2026 17:17

Manufacturer products Authorised representative products Authorised representative actors View details

mLabs® ImmunoMeter

m-101

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

Manufacturer: Micropoint Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000007991
UDI-DI: 06974703168081
Basic UDI-DI: 697470316m-101HS
Reference: m-101
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 02.07.2026 17:17

Manufacturer products Authorised representative products Authorised representative actors View details

Fluorescence Immunoassay Analyzer

FIS-1000

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Zijian Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000022829
UDI-DI: 06974674892107
Basic UDI-DI: 697467489000389R
Reference: 18-05-0027
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Netherlands
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 17:08

Manufacturer products Authorised representative products Authorised representative actors View details

Chemiluminescence Immunoassay Analyzer

C 900

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Aikang MedTech Co., Ltd
Manufacturer SRN: CN-MF-000027272
UDI-DI: 06974621212392
Basic UDI-DI: 697462121C900C5
Reference: C 900
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 17:04

Manufacturer products Authorised representative products Authorised representative actors View details

Chemiluminescence Immunoassay Analyzer

CLIA-mate Series

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Aikang MedTech Co., Ltd
Manufacturer SRN: CN-MF-000027272
UDI-DI: 06974621212118
Basic UDI-DI: 697462121CLIAmateGJ
Reference: CLIA-mate
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 17:04

Manufacturer products Authorised representative products Authorised representative actors View details

Fluorescent Immunoanalyzer

YFA 100

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Aikang MedTech Co., Ltd
Manufacturer SRN: CN-MF-000027272
UDI-DI: 06974621212101
Basic UDI-DI: 697462121YFA100FJ
Reference: YFA 100
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 17:04

Manufacturer products Authorised representative products Authorised representative actors View details

06974621211722

URANUS AE Series

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Aikang MedTech Co., Ltd
Manufacturer SRN: CN-MF-000027272
UDI-DI: 06974621211722
Basic UDI-DI: 697462121URANUSAEL3
Reference: URANUS AE 55
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 17:04

Manufacturer products Authorised representative products Authorised representative actors View details

Automated Chemiluminescence Immunoassay Analyzer

Lumimate 300A

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Aikang MedTech Co., Ltd
Manufacturer SRN: CN-MF-000027272
UDI-DI: 06974621211579
Basic UDI-DI: 697462121LumimateZQ
Reference: Lumimate 300A
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 17:04

Manufacturer products Authorised representative products Authorised representative actors View details