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760 device results listed.

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06975140170323

shine i1900

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: Shenzhen Increcare Biotech Co., Ltd
Manufacturer SRN: CN-MF-000027299
UDI-DI: 06975140170323
Basic UDI-DI: 697514017YK-SHINE-I1900UH
Reference: 06975140170323
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 18:15

Manufacturer products Authorised representative products Authorised representative actors View details

06975140170248

Shine i2910

IVD Class AIVDR 2017/746On the marketHuman tissuesInstrumentKitProfessional testing

Manufacturer: Shenzhen Increcare Biotech Co., Ltd
Manufacturer SRN: CN-MF-000027299
UDI-DI: 06975140170248
Basic UDI-DI: 697514017shine-i29108D
Reference: GS1
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 18:15

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06975140170187

Shine i2110

IVD Class AIVDR 2017/746On the marketHuman tissuesInstrumentKitProfessional testing

Manufacturer: Shenzhen Increcare Biotech Co., Ltd
Manufacturer SRN: CN-MF-000027299
UDI-DI: 06975140170187
Basic UDI-DI: 697514017Shinei2110FV
Reference: GS1
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 18:15

Manufacturer products Authorised representative products Authorised representative actors View details

06975140170064

shine i2900

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: Shenzhen Increcare Biotech Co., Ltd
Manufacturer SRN: CN-MF-000027299
UDI-DI: 06975140170064
Basic UDI-DI: 697514017YK-SH-IRD
Reference: 06975140170064
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 18:15

Manufacturer products Authorised representative products Authorised representative actors View details

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

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

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

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