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Chemiluminescence Immunoassay Analyzer

CS-SA301C

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

Manufacturer: Hangzhou Dalton BioSciences, Ltd.
Manufacturer SRN: CN-MF-000036196
UDI-DI: 06973873149012
Basic UDI-DI: 697387314SACVC
Reference: CS-SA301C
EMDN: W0201020104
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HIGH ROUTINE (Throughput > 700 test/h)
First on market country: -
Authorised representative: Humiss Beratung GmbH
Last updated: 02.07.2026 15:08

Manufacturer products Authorised representative products Authorised representative actors View details

Anbio Biotechnology

AF-100, AF-100S, AF-100C, AF-1200

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Anbio Biotechnology Limited
Manufacturer SRN: CN-MF-000042849
UDI-DI: 06973861682552
Basic UDI-DI: 6973861682552FJ
Reference: AF-100
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 02.07.2026 15:05

Manufacturer products Authorised representative products Authorised representative actors View details

Anbio

AF-100, AF-100S, AF-100C, AF-1200

IVD Class AIVDR 2017/746On the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Anbio (Xiamen) Biotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000023936
UDI-DI: 06973861681715
Basic UDI-DI: 6973861681647FP
Reference: AF-1200
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 15:05

Manufacturer products Authorised representative products Authorised representative actors View details

Anbio

Automatic Luminescence Immunoassay Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Anbio (Xiamen) Biotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000023936
UDI-DI: 06973861680282
Basic UDI-DI: 6973861680282EW
Reference: ADL-i1910
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 15:05

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

06973609150190

DM 801B

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Yantai Addcare Bio-Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000018409
UDI-DI: 06973609150190
Basic UDI-DI: 697360915019KT
Reference: （01）6973609150190（11）210518（21）5C12021002
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
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

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Dry Fluorescence Immunoassay Analyzer

FIC-H1W、FIC-H1N、FIC-Q100、FIC-Q100N、FIC-H2、FIC-S100、FIC-A1600、FIC-M6、FIC-M6G、FIC-H0、FIC-H0mini、FIC-M2、FIC-M2NT

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsDirect markingInstrumentNear-patient testingProfessional testing

Manufacturer: Suzhou Helmen Precision Insturments Co.,Ltd
Manufacturer SRN: CN-MF-000002230
UDI-DI: 06973602150012
Basic UDI-DI: 697360215FICNY
Reference: FIC-H1W
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 14:48

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