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04049095260155

RIDA®Q3

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: R-Biopharm AG
Manufacturer SRN: DE-MF-000007993
UDI-DI: 04049095260155
Basic UDI-DI: 4049095ZRQ3000000FP
Reference: ZRQ3
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:53

Manufacturer products View details

04049095260117

RIDA®QUICK SCAN II

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: R-Biopharm AG
Manufacturer SRN: DE-MF-000007993
UDI-DI: 04049095260117
Basic UDI-DI: 4049095ZRQS2KD000E6
Reference: ZRQS2-KD
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:53

Manufacturer products View details

IDS-iSYS Multi-Discipline Automated System

IS-310400

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: ImmunoDiagnostic Systems France
Manufacturer SRN: FR-MF-000023843
UDI-DI: 03760173851003
Basic UDI-DI: 3760173851003YL
Reference: IS-310400
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 15:16

Manufacturer products View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

Chemiluminescence Immunoassay Analyzer

IVD Class ANot specifiedOn the marketDirect marking

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: 06921963722966
Basic UDI-DI: 692196372293JG
Reference: BOSON 1000
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 01.07.2026 07:11

Manufacturer products Authorised representative products Authorised representative actors View details

Automated Chemiluminescent Enzyme Immunoassay Analyzer AIA-CL2400

IVD Class ANot specifiedOn the market

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 04562185396911
Basic UDI-DI: 45601892100040047M
Reference: 0023651
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 30.06.2026 15:55

Manufacturer products Authorised representative products Authorised representative actors View details

Automated Chemiluminescent Enzyme Immunoassay Analyzer AIA-CL1200

IVD Class ANot specifiedOn the market

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 04562185400588
Basic UDI-DI: 45601892100040047M
Reference: 0024130
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 30.06.2026 15:55

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Automated Chemiluminescent Enzyme Immunoassay Analyzer AIA-CL1200

IVD Class ANot specifiedOn the market

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 04562185400595
Basic UDI-DI: 45601892100040047M
Reference: 0024131
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 30.06.2026 15:55

Manufacturer products Authorised representative products Authorised representative actors View details

Auto-Prep Unit for AIA-CL1200

IVD Class ANot specifiedOn the market

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 04562185400601
Basic UDI-DI: 45601892100040047M
Reference: 0024132
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 30.06.2026 15:55

Manufacturer products Authorised representative products Authorised representative actors View details

Automated Chemiluminescent Enzyme Immunoassay Analyzer AIA-CL300

IVD Class ANot specifiedOn the market

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 04562185404814
Basic UDI-DI: 45601892100040047M
Reference: 0024450
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 30.06.2026 15:55

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Chemiluminescence Analyzer

VIT 700

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Tailaored Medical .Ltd
Manufacturer SRN: CN-MF-000029307
UDI-DI: 06970879394644
Basic UDI-DI: 697087939HF000KQ
Reference: VIT 700
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Spain
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 09:38

Manufacturer products Authorised representative products Authorised representative actors View details

Chemiluminescence Digital Imaging Analyzer

CIS-2E: Chemiluminescent Imaging System Type 2E

IVD generalIVDDOn the marketProfessional testing

Manufacturer: Sino-Swed TongKang Bio-Tech (Shenzhen) Limited.
Manufacturer SRN: CN-MF-000033668
UDI-DI: 06970698569506
Basic UDI-DI: B-06970698569506
Reference: /
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Sweden
Authorised representative: Umedwings Netherlands B.V.
Last updated: 30.06.2026 08:16

Manufacturer products Authorised representative products Authorised representative actors View details

Fluorescent Immunoanalyzer

DFI-1000

IVD Class AIVDR 2017/746On the marketInstrumentKitProfessional testing

Manufacturer: Sino-Swed TongKang Bio-Tech (Shenzhen) Limited.
Manufacturer SRN: CN-MF-000033668
UDI-DI: 06970698560251
Basic UDI-DI: 697069856DFI1000P7
Reference: /
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Sweden
Authorised representative: Umedwings Netherlands B.V.
Last updated: 30.06.2026 08:16

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Chemistry Analyzer

CA2000

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testingSingle use

Manufacturer: Sichuan Orienter Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000003026
UDI-DI: 06970522646960
Basic UDI-DI: 697052264YQ09KX
Reference: QD0401
EMDN: W0201020104
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HIGH ROUTINE (Throughput > 700 test/h)
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 30.06.2026 04:46

Manufacturer products Authorised representative products Authorised representative actors View details

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

Automatic Chemiluminescence Immunoassay Analyzer

LA 2000

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testingSingle use

Manufacturer: Sichuan Orienter Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000003026
UDI-DI: 06970522640036
Basic UDI-DI: 697052264YQ03KK
Reference: QD0201
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 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

06970514080758

Immunochromatography Analyzer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Genobio Pharmaceutical Co., Ltd.
Manufacturer SRN: CN-MF-000027997
UDI-DI: 06970514080758
Basic UDI-DI: 697051408GICN2
Reference: GIC-H1W
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: 30.06.2026 04:07

Manufacturer products Authorised representative products Authorised representative actors View details

06970514080734

Fully Automatic Kinetic Tube Reader

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Genobio Pharmaceutical Co., Ltd.
Manufacturer SRN: CN-MF-000027997
UDI-DI: 06970514080734
Basic UDI-DI: 697051408IGL200A5
Reference: IGL-200
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: 30.06.2026 04:07

Manufacturer products Authorised representative products Authorised representative actors View details

06970514080710

Full-Automatic Chemiluminescence Immunoassay System

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Genobio Pharmaceutical Co., Ltd.
Manufacturer SRN: CN-MF-000027997
UDI-DI: 06970514080710
Basic UDI-DI: 697051408FACISICZ
Reference: FACIS-I
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: 30.06.2026 04:07

Manufacturer products Authorised representative products Authorised representative actors View details

06970341684785

eCL8000x

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

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06970341684785
Basic UDI-DI: 6970341680120501H7
Reference: 0120508
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 30.06.2026 01:56

Manufacturer products Authorised representative products Authorised representative actors View details