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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

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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

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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

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

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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

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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

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Automatic Chemiluminescence Immunoassay Analyzer

VERCENTRA CS-1500, VERCENTRA CS-3000

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Virtue Diagnostics (Suzhou) Co., Ltd
Manufacturer SRN: CN-MF-000013251
UDI-DI: 06974402559012
Basic UDI-DI: 697440255INST_VIRTUOSO6E
Reference: 11000002
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Netherlands
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 15:57

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

06974071231059

Palm F

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shijiazhuang Hipro Biotechnology Co.,Ltd
Manufacturer SRN: CN-MF-000002171
UDI-DI: 06974071231059
Basic UDI-DI: 697407123PalmFX4
Reference: Palm F
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Germany
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 02.07.2026 15:24

Manufacturer products Authorised representative products Authorised representative actors View details

06974071231011

HP-AFS/1

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Shijiazhuang Hipro Biotechnology Co.,Ltd
Manufacturer SRN: CN-MF-000002171
UDI-DI: 06974071231011
Basic UDI-DI: 697407123HP-AFS/1QG
Reference: HP-AFS/1
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Germany
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 02.07.2026 15:24

Manufacturer products Authorised representative products Authorised representative actors View details