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06975569870132

CLS60

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Shenzhen Sinseng Medical Technology Co., Ltd
Manufacturer SRN: CN-MF-000024231
UDI-DI: 06975569870132
Basic UDI-DI: 697556987CLS60UF
Reference: CLS60
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Austria
Authorised representative: Sungo Cert GmbH
Last updated: 02.07.2026 19:17

Manufacturer products Authorised representative products Authorised representative actors View details

Automated CLEIA system

lumilite8

IVD Class AIVDR 2017/746Not intended for EU marketCompanion diagnosticsInstrumentProfessional testing

Manufacturer: Chengdu Illumaxbio Technology Co.,LTD
Manufacturer SRN: CN-MF-000026407
UDI-DI: 06975292640026
Basic UDI-DI: 697529264002MS
Reference: 102
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 18:34

Manufacturer products Authorised representative products Authorised representative actors View details

Automated CLEIA system

Professional testing

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testingSelf testing

Manufacturer: Chengdu Illumaxbio Technology Co.,LTD
Manufacturer SRN: CN-MF-000026407
UDI-DI: 06975292640019
Basic UDI-DI: 697529264001MQ
Reference: 101
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Türkiye
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 18:34

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Automated Electrochemiluminescence (ECL) Immunoassay Analyzer

YnY 2050;YnY 2050d;YnY 2050h

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testingSingle use

Manufacturer: Accucise Diagnostics Inc.
Manufacturer SRN: CN-MF-000045017
UDI-DI: 06975140163011
Basic UDI-DI: 697509050YnY2050BH
Reference: A18111000003,A18111000004,A18111000005
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

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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

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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

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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

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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

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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

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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

POCLia8

Chemiluminescence Immunoassay Analyzer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Taizhou Zecen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000050486
UDI-DI: 06974201150762
Basic UDI-DI: 697420115YQ001DZ
Reference: Chemiluminescence Immunoassay Analyzer
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: France
Authorised representative: MedPath GmbH
Last updated: 02.07.2026 15:39

Manufacturer products Authorised representative products Authorised representative actors View details

Automated Chemiluminescent Immunoassay Analyzing System

MS-Fast pro 240

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Sophonix Co., Ltd.
Manufacturer SRN: CN-MF-000021894
UDI-DI: 06974183540872
Basic UDI-DI: 697418354A07NT
Reference: A07
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 15:38

Manufacturer products Authorised representative products Authorised representative actors View details

Automated Chemiluminescent Immunoassay Analyzing System

MS-Fast pro 160

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Sophonix Co., Ltd.
Manufacturer SRN: CN-MF-000021894
UDI-DI: 06974183540865
Basic UDI-DI: 697418354A06NR
Reference: A06
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 15:38

Manufacturer products Authorised representative products Authorised representative actors View details

Automated Chemiluminescent Immunoassay Analyzing System

MS-Fast pro 80

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Sophonix Co., Ltd.
Manufacturer SRN: CN-MF-000021894
UDI-DI: 06974183540841
Basic UDI-DI: 697418354A05NP
Reference: A05
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 15:37

Manufacturer products Authorised representative products Authorised representative actors View details

Automated Chemiluminescent Immunoassay Analyzing System

Aceso 80A

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Sophonix Co., Ltd.
Manufacturer SRN: CN-MF-000021894
UDI-DI: 06974183540834
Basic UDI-DI: 697418354A08NV
Reference: A08
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 15:37

Manufacturer products Authorised representative products Authorised representative actors View details

Automated Chemiluminescent Immunoassay Analyzing System

Aceso 80A

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Sophonix Co., Ltd.
Manufacturer SRN: CN-MF-000021894
UDI-DI: 06974183540292
Basic UDI-DI: 697418354A02NH
Reference: A02
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 15:37

Manufacturer products Authorised representative products Authorised representative actors View details

Automated Chemiluminescent Immunoassay Analyzing System

MS-Fast

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Sophonix Co., Ltd.
Manufacturer SRN: CN-MF-000021894
UDI-DI: 06974183540216
Basic UDI-DI: 697418354A01NF
Reference: A01
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 15:37

Manufacturer products Authorised representative products Authorised representative actors View details

Fluorescence Immunoassay Analyzer

FluoreMini

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: SINGUWAY BIOTECH INC.
Manufacturer SRN: CN-MF-000027180
UDI-DI: 06974081870736
Basic UDI-DI: 697408187FluoreMiniL4
Reference: FluoreMini
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Greece
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 15:26

Manufacturer products Authorised representative products Authorised representative actors View details