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55 device results listed.

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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

Immunofluorescence Analyzer

WS-Si1500

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Guangdong Wesail Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008828
UDI-DI: 06973841000826
Basic UDI-DI: 697384100B15004T
Reference: WS-Si1500
EMDN: W0201020103
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h)
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 02.07.2026 15:01

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Immunofluorescence Analyzer

WS-Si1000

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Guangdong Wesail Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008828
UDI-DI: 06973841000789
Basic UDI-DI: 697384100B100042
Reference: WS-Si1000
EMDN: W0201020103
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h)
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 02.07.2026 15:01

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Immunofluorescence Analyzer

WS-Mi6000

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Guangdong Wesail Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008828
UDI-DI: 06973841000307
Basic UDI-DI: 697384100B600055
Reference: WS-Mi6000
EMDN: W0201020103
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h)
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 02.07.2026 15:01

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Handheld Colloidalgold Analyzer

WS-Si1400

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Guangdong Wesail Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008828
UDI-DI: 06973841000284
Basic UDI-DI: 697384100H14006Q
Reference: WS-Si1400
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

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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

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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

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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

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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 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 Chemiluminescence Analyzer

i 6000

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Maccura Medical Instrument Co., Ltd.
Manufacturer SRN: CN-MF-000028087
UDI-DI: 06972168353806
Basic UDI-DI: 69721683511049V
Reference: EIM9402025
EMDN: W0201020103
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h)
First on market country: Türkiye
Authorised representative: Humiss International B.V.
Last updated: 02.07.2026 12:35

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Automated ECLImmunoassay Analyzer

eCL8600, eCL8600i, eCL8600p, eCL8800, eCL8800i, eCL8800p

IVD Class AIVDR 2017/746On the marketInstrumentKitProfessional testing

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06978139070758
Basic UDI-DI: 6970341680120504HD
Reference: 012130101
EMDN: W0201020103
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h)
First on market country: Netherlands
Authorised representative: Umedwings Netherlands B.V.
Last updated: 02.07.2026 11:19

Manufacturer products Authorised representative products Authorised representative actors View details

Automated ECLImmunoassay Analyzer

eCL9000、eCL9600、eCL9900、eCL9900i

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984062365
Basic UDI-DI: 6970341680120503HB
Reference: 0120512
EMDN: W0201020103
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h)
First on market country: Netherlands
Authorised representative: Umedwings Netherlands B.V.
Last updated: 02.07.2026 11:18

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GSP, Genetic Screening Processor

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Wallac Oy
Manufacturer SRN: FI-MF-000022620
UDI-DI: 06438147311040
Basic UDI-DI: 6438147GSP_7V
Reference: 2021-0010
EMDN: W0201020103
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h)
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:03

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DxI 9000 Access Immunoassay Analyzer

C11137

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590732103
Basic UDI-DI: 150995901DXI9000INSTRTQ
Reference: C11137
EMDN: W0201020103
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h)
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:39

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Automatic Chemiluminescence Immunoassay Analyzer

LA 3000

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testingSingle use

Manufacturer: Sichuan Orienter Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000003026
UDI-DI: 06970522640043
Basic UDI-DI: 697052264YQ08KV
Reference: QD0301
EMDN: W0201020103
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h)
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 04:44

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI X6

Fully-auto chemiluminescence immunoassay analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145528782
Basic UDI-DI: 69471455X6GB
Reference: 010101006601
EMDN: W0201020103
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:19

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI X8

Fully-auto chemiluminescence immunoassay analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145513467
Basic UDI-DI: 69471455X8GF
Reference: 010101008801
EMDN: W0201020103
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:18

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Chemiluminescence Analyzer

Lumiray 4080

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: 06947024411976
Basic UDI-DI: 694702440983688
Reference: Lumiray 4080
EMDN: W0201020103
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:00

Manufacturer products Authorised representative products Authorised representative actors View details