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A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06973262866162
Basic UDI-DI: 69732628600007ZL
Reference: 02-12-02-0012-00
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 16.06.2026 13:22

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer: Xiamen United Medical Instruments Co., Ltd.
Manufacturer SRN: CN-MF-000028165
UDI-DI: 06973597100092
Basic UDI-DI: 697359710Wan200+GK
Reference: Wan200+ A
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 16.06.2026 13:19

Manufacturer products Authorised representative products Authorised representative actors View details

Dry Fluorescence Immunoassay Analyzer

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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: 06973602150029
Basic UDI-DI: 697360215FICNY
Reference: FIC-H1N
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 16.06.2026 13:19

Manufacturer products Authorised representative products Authorised representative actors View details

Dry Fluorescence Immunoassay Analyzer

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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: 06973602150111
Basic UDI-DI: 697360215FICNY
Reference: FIC-S100
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 16.06.2026 13:19

Manufacturer products Authorised representative products Authorised representative actors View details

Dry Fluorescence Immunoassay Analyzer

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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: 06973602150210
Basic UDI-DI: 697360215FICNY
Reference: FIC-Q100N
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 16.06.2026 13:19

Manufacturer products Authorised representative products Authorised representative actors View details

Dry Fluorescence Immunoassay Analyzer

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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: 06973602150227
Basic UDI-DI: 697360215FICNY
Reference: FIC-Q100
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 16.06.2026 13:19

Manufacturer products Authorised representative products Authorised representative actors View details

Dry Fluorescence Immunoassay Analyzer

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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: 06973602150319
Basic UDI-DI: 697360215FICNY
Reference: FIC-M6
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 16.06.2026 13:19

Manufacturer products Authorised representative products Authorised representative actors View details

Dry Fluorescence Immunoassay Analyzer

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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: 06973602150326
Basic UDI-DI: 697360215FICNY
Reference: FIC-M6G
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 16.06.2026 13:19

Manufacturer products Authorised representative products Authorised representative actors View details

Dry Fluorescence Immunoassay Analyzer

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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: 06973602150418
Basic UDI-DI: 697360215FICNY
Reference: FIC-A1600
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 16.06.2026 13:19

Manufacturer products Authorised representative products Authorised representative actors View details

Dry Fluorescence Immunoassay Analyzer

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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: 06973602150517
Basic UDI-DI: 697360215FICNY
Reference: FIC-H2
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 16.06.2026 13:19

Manufacturer products Authorised representative products Authorised representative actors View details

Dry Fluorescence Immunoassay Analyzer

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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: 06973602150616
Basic UDI-DI: 697360215FICNY
Reference: FIC-H0mini
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 16.06.2026 13:19

Manufacturer products Authorised representative products Authorised representative actors View details

Dry Fluorescence Immunoassay Analyzer

-

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: 06973602150623
Basic UDI-DI: 697360215FICNY
Reference: FIC-H0
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 16.06.2026 13:19

Manufacturer products Authorised representative products Authorised representative actors View details

Dry Fluorescence Immunoassay Analyzer

-

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: 06973602151415
Basic UDI-DI: 697360215FICNY
Reference: FIC-M2
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 16.06.2026 13:19

Manufacturer products Authorised representative products Authorised representative actors View details

Dry Fluorescence Immunoassay Analyzer

-

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: 06973602151422
Basic UDI-DI: 697360215FICNY
Reference: FIC-M2NT
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 16.06.2026 13:19

Manufacturer products Authorised representative products Authorised representative actors View details

Dry Fluorescence Immunoassay Analyzer

-

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: 06973602151439
Basic UDI-DI: 697360215FICNY
Reference: FIC- NTIMM3
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 16.06.2026 13:19

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer: Anbio (Xiamen) Biotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000023936
UDI-DI: 06973861681722
Basic UDI-DI: 6973861681647FP
Reference: AF-100
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 16.06.2026 13:13

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer: Anbio (Xiamen) Biotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000023936
UDI-DI: 06973861681739
Basic UDI-DI: 6973861681647FP
Reference: AF-100S
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 16.06.2026 13:13

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer: Anbio (Xiamen) Biotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000023936
UDI-DI: 06973861681746
Basic UDI-DI: 6973861681647FP
Reference: AF-100C
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 16.06.2026 13:13

Manufacturer products Authorised representative products Authorised representative actors View details

Anbio Biotechnology

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IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Anbio Biotechnology Limited
Manufacturer SRN: CN-MF-000042849
UDI-DI: 06973861682569
Basic UDI-DI: 6973861682552FJ
Reference: AF-100S
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: -
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 16.06.2026 13:13

Manufacturer products Authorised representative products Authorised representative actors View details

Anbio Biotechnology

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IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Anbio Biotechnology Limited
Manufacturer SRN: CN-MF-000042849
UDI-DI: 06973861682576
Basic UDI-DI: 6973861682552FJ
Reference: AF-100C
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: -
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 16.06.2026 13:13

Manufacturer products Authorised representative products Authorised representative actors View details