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CS-1600

CS-1300B CS-1600

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794504883
Basic UDI-DI: 69257945W0201010103D0JR
Reference: 3019011
EMDN: W0201010103
EMDN description: CHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Random access without ISE mode test/h > 800 and <= 1.200)
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 18:27

Manufacturer products Authorised representative products Authorised representative actors View details

CS-600B

CS-600B CS-650 CS-680 CS-1200

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794504647
Basic UDI-DI: 69257945W0201010102D0JL
Reference: 3000085
EMDN: W0201010102
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)
First on market country: Spain
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 18:27

Manufacturer products Authorised representative products Authorised representative actors View details

CS-T240

DR-7000D CS-T180 CS-T240 CS-T240Plus CS-300B CS-400 CS-480

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794504579
Basic UDI-DI: 69257945W0201010101D0JF
Reference: 3000103
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Spain
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 18:27

Manufacturer products Authorised representative products Authorised representative actors View details

H-100

H-100,H-500,HC-300

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794501295
Basic UDI-DI: 69257945W020101020102D0B3
Reference: 3000068
EMDN: W020101020102
EMDN description: SEMI-AUTOMATED URINE ANALYSERS
First on market country: Poland
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 18:27

Manufacturer products Authorised representative products Authorised representative actors View details

Colloidal Gold Immunoassay Analyzer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: 06921963722973
Basic UDI-DI: 692196372294JJ
Reference: CG-300
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 31.07.2026 18:12

Manufacturer products Authorised representative products Authorised representative actors View details

Chemiluminescence Immunoassay Analyzer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: 06921963722959
Basic UDI-DI: 692196372293JG
Reference: BOSON 3000
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 31.07.2026 18:12

Manufacturer products Authorised representative products Authorised representative actors View details

Fluorescence Immunoassay Analyzer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: 06921963719669
Basic UDI-DI: 692196371965K7
Reference: QDS-300A
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 31.07.2026 18:12

Manufacturer products Authorised representative products Authorised representative actors View details

Urine Analyzer UAM1412

UAM1412

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsDirect markingInstrumentKitProfessional testing

Manufacturer: BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000033011
UDI-DI: 06921807611487
Basic UDI-DI: 692180764010F6
Reference: JY44UAM1412
EMDN: W020101020102
EMDN description: SEMI-AUTOMATED URINE ANALYSERS
First on market country: Germany
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 31.07.2026 18:11

Manufacturer products Authorised representative products Authorised representative actors View details

Urine Analyzer

UAM1411

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsDirect markingInstrumentProfessional testingSingle use

Manufacturer: BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000033011
UDI-DI: 06921807611470
Basic UDI-DI: 692180764009FM
Reference: JY43UAM1411
EMDN: W020101020102
EMDN description: SEMI-AUTOMATED URINE ANALYSERS
First on market country: France
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 31.07.2026 18:11

Manufacturer products Authorised representative products Authorised representative actors View details

Dry Biochemical Analyzer MBM001

MBM001

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsDirect markingInstrumentProfessional testingSingle use

Manufacturer: BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000033011
UDI-DI: 06921807611463
Basic UDI-DI: 692180764008FK
Reference: JY42MBM001
EMDN: W0201010102
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)
First on market country: Germany
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 31.07.2026 18:11

Manufacturer products Authorised representative products Authorised representative actors View details

Fluorescence Immunoassay Analyzer LEPU Quant 1600

LEPU Quant-Fluo 1600

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsDirect markingInstrumentProfessional testingSingle use

Manufacturer: BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000033011
UDI-DI: 06921807605035
Basic UDI-DI: 692180760503F6
Reference: JY20LEPUQuant-Fluo1600
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: France
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 31.07.2026 18:11

Manufacturer products Authorised representative products Authorised representative actors View details

Colloidal Gold Immunochromatograpic Assay Analyzer LEPU Quant 800

LEPU Quant 800

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsDirect markingInstrumentProfessional testingSingle use

Manufacturer: BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000033011
UDI-DI: 06921807601136
Basic UDI-DI: 692180760113EM
Reference: JY04LEPU Quant 800
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: France
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 31.07.2026 18:11

Manufacturer products Authorised representative products Authorised representative actors View details

Fluorescence immunochromatography analyzer LEPU Quant-Fluo800

LEPU Quant-Fluo800

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsDirect markingInstrumentKitProfessional testing

Manufacturer: BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000033011
UDI-DI: 06921807600726
Basic UDI-DI: 692180760072EY
Reference: JY05LEPU Quant-Fluo 800
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Belgium
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 31.07.2026 18:11

Manufacturer products Authorised representative products Authorised representative actors View details

On Call

OGM-361

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

Manufacturer: Acon Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000006977
UDI-DI: 06921756497736
Basic UDI-DI: 6921756499990073XG
Reference: GN112-111-201
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Poland
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 18:10

Manufacturer products Authorised representative products Authorised representative actors View details

06921026705264

Jet-iStar 800

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Joinstar Biomedical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000001083
UDI-DI: 06921026705264
Basic UDI-DI: 69210267JS800GJ
Reference: JS800
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Bulgaria
Authorised representative: Lotus NL B.V.
Last updated: 31.07.2026 18:07

Manufacturer products Authorised representative products Authorised representative actors View details

Labmaster LUCIA™ Analyzer

LM26

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

Manufacturer: Labmaster Oy
Manufacturer SRN: FI-MF-000023942
UDI-DI: 06429810777003
Basic UDI-DI: 6429810777LM268N
Reference: LM26
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 17:45

Manufacturer products View details

QC Cassette

IVD Class AIVDR 2017/746On the market

Manufacturer: Biohit Oyj
Manufacturer SRN: FI-MF-000014642
UDI-DI: 06419587350004
Basic UDI-DI: 6419587QC0010PV
Reference: 740470
EMDN: W0201069080
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 17:36

Manufacturer products View details

GP Reader NT

HIT-92A

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

Manufacturer: Biohit Oyj
Manufacturer SRN: FI-MF-000014642
UDI-DI: 06419587343006
Basic UDI-DI: 6419587RNT0103T
Reference: 740450
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 17:36

Manufacturer products View details

Atellica DT 250 analyzer

Chemistry Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Diatron Medicinai Instrumentumok Laboratóriumi Diagnosztikai Fejlesztő-Gyártó Zártkörűen Működő Részvénytársaság
Manufacturer SRN: HU-MF-000020416
UDI-DI: 05999883586747
Basic UDI-DI: 5999883586ADTVF
Reference: 11310504
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Hungary
Authorised representative: -
Last updated: 31.07.2026 16:47

Manufacturer products View details

Pictus 700 Clinical chemistry analyzer with ISE module

Clinilcal Chemistry analyzers

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Diatron Medicinai Instrumentumok Laboratóriumi Diagnosztikai Fejlesztő-Gyártó Zártkörűen Működő Részvénytársaság
Manufacturer SRN: HU-MF-000020416
UDI-DI: 05999860094180
Basic UDI-DI: 5999860094PCCRQ
Reference: P700-3
EMDN: W0201010106
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (with ISE mode test/h > 400 and <= 800)
First on market country: Hungary
Authorised representative: -
Last updated: 31.07.2026 16:40

Manufacturer products View details