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837 device results listed.

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Handheld Immunofluorescence Analyzer

WS-Si1300

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Guangdong Wesail Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008828
UDI-DI: 06973841000277
Basic UDI-DI: 697384100B13004H
Reference: WS-Si1300
EMDN: W0201020103
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h)
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 15:01

Manufacturer products Authorised representative products Authorised representative actors View details

06973609151197

ADC ELISA 190

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Yantai Addcare Bio-Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000018409
UDI-DI: 06973609151197
Basic UDI-DI: 697360915119KY
Reference: W0201020101
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Austria
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 02.07.2026 14:49

Manufacturer products Authorised representative products Authorised representative actors View details

06973609150800

iTube 3000

IVD Class AIVDR 2017/746Not intended for EU marketDirect markingInstrumentProfessional testing

Manufacturer: Yantai Addcare Bio-Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000018409
UDI-DI: 06973609150800
Basic UDI-DI: 697360915080KW
Reference: （01）6973609150800（11）210110（21）5802021001
EMDN: W0201020103
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h)
First on market country: Austria
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 02.07.2026 14:49

Manufacturer products Authorised representative products Authorised representative actors View details

06973609150176

iTube 1000

IVD Class AIVDR 2017/746Not intended for EU marketDirect markingInstrumentProfessional testing

Manufacturer: Yantai Addcare Bio-Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000018409
UDI-DI: 06973609150176
Basic UDI-DI: 697360915017KP
Reference: （01）6973609150176（11）210112（21）5A92021001
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Austria
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 02.07.2026 14:49

Manufacturer products Authorised representative products Authorised representative actors View details

06973609150107

ADC ELISA 180

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Yantai Addcare Bio-Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000018409
UDI-DI: 06973609150107
Basic UDI-DI: 697360915010K9
Reference: （01）6973609150107（11）210111（21）5102021001
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Romania
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 02.07.2026 14:49

Manufacturer products Authorised representative products Authorised representative actors View details

06973609150091

ADC ELISA 200

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Yantai Addcare Bio-Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000018409
UDI-DI: 06973609150091
Basic UDI-DI: 697360915009KQ
Reference: （01）6973609150091（11）210105（21）5092021001
EMDN: W0201020103
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h)
First on market country: Spain
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 02.07.2026 14:49

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06973609150077

ADC ELISA 400

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Yantai Addcare Bio-Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000018409
UDI-DI: 06973609150077
Basic UDI-DI: 697360915007KL
Reference: （01）6973609150077（11）210104（21）5072021001
EMDN: W0201020103
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h)
First on market country: Spain
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 02.07.2026 14:49

Manufacturer products Authorised representative products Authorised representative actors View details

06973609150053

ADC ELISA 600

IVD Class AIVDR 2017/746Not intended for EU marketDirect markingInstrumentProfessional testing

Manufacturer: Yantai Addcare Bio-Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000018409
UDI-DI: 06973609150053
Basic UDI-DI: 697360915005KG
Reference: （01）6973609150053（11）210108（21）5052021001
EMDN: W0201020104
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HIGH ROUTINE (Throughput > 700 test/h)
First on market country: Austria
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 02.07.2026 14:49

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06973609150022

ADC ELISA 1800

IVD Class AIVDR 2017/746Not intended for EU marketDirect markingInstrumentProfessional testing

Manufacturer: Yantai Addcare Bio-Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000018409
UDI-DI: 06973609150022
Basic UDI-DI: 697360915002KA
Reference: NO
EMDN: W0201020104
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HIGH ROUTINE (Throughput > 700 test/h)
First on market country: -
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 02.07.2026 14:49

Manufacturer products Authorised representative products Authorised representative actors View details

06973597100382

Wan600

IVD Class AIVDR 2017/746Not intended for EU marketInstrumentProfessional testing

Manufacturer: Xiamen United Medical Instruments Co., Ltd.
Manufacturer SRN: CN-MF-000028165
UDI-DI: 06973597100382
Basic UDI-DI: 697359710Wan6007B
Reference: Wan600 A
EMDN: W0201020103
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h)
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 02.07.2026 14:48

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Fluorescence Immunoassay Analyzer

QD-S2000

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
UDI-DI: 06973315739580
Basic UDI-DI: 6973315739580BG
Reference: QD-S2000
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 14:29

Manufacturer products Authorised representative products Authorised representative actors View details

Quantum Dot Fluorescence Immune Analyzer

QD-S600

IVD Class AIVDR 2017/746On the marketDirect markingInstrument

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
UDI-DI: 06973315739566
Basic UDI-DI: 6973315739566BN
Reference: QD-S600
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 14:29

Manufacturer products Authorised representative products Authorised representative actors View details

Fluorescence Immune Analyzer

QD-S900

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
UDI-DI: 06973315734707
Basic UDI-DI: 6973315738668BQ
Reference: QD-S900
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 14:29

Manufacturer products Authorised representative products Authorised representative actors View details

06973262866131

EXI 1800, EXI 1810, EXI 1820, EXI 1830

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06973262866131
Basic UDI-DI: 69732628600007ZL
Reference: 02-12-02-0004-00
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 14:27

Manufacturer products Authorised representative products Authorised representative actors View details

06973262866117

Q8 Pro

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06973262866117
Basic UDI-DI: 69732628600006ZJ
Reference: 02-11-01-0001-00
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 14:27

Manufacturer products Authorised representative products Authorised representative actors View details

06973224890891

iStar 2000-A/ iStar 2000-B/ iStar 2000-C

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: 06973224890891
Basic UDI-DI: 6973224890071AH
Reference: FD0220
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 14:25

Manufacturer products Authorised representative products Authorised representative actors View details

06973224890259

iStar 500

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: 06973224890259
Basic UDI-DI: 6973224890040A6
Reference: FG0054
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 14:24

Manufacturer products Authorised representative products Authorised representative actors View details

06973224890143

96 pcs/rack, 20 racks/box

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: 06973224890143
Basic UDI-DI: 6973224890073AM
Reference: C0010
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 14:24

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Luminescence Immunoassay Analyzer

AutoLumo A6000、AutoLumo A6200、AutoLumo A6600、AutoLumo A6800

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Autobio Labtec Instruments Co.,Ltd.
Manufacturer SRN: CN-MF-000012110
UDI-DI: 06973049096881
Basic UDI-DI: 697304909Model72UP
Reference: 07061
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 13:30

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Luminescence Immunoassay Analyzer

AutoLumo A1800, AutoLumo A1820, AutoLumo A1860, AutoLumo A1880

IVD Class AIVDR 2017/746No longer on the marketDirect markingInstrumentProfessional testing

Manufacturer: Autobio Labtec Instruments Co.,Ltd.
Manufacturer SRN: CN-MF-000012110
UDI-DI: 06973049096836
Basic UDI-DI: 697304909Model70UK
Reference: 07071
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 02.07.2026 13:30

Manufacturer products Authorised representative products Authorised representative actors View details