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Probe Washing Buffer

Chemiluminescence Immunoassay Reagent

IVD Class AIVDR 2017/746On the marketReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794577412
Basic UDI-DI: 69257945W01029099R05H
Reference: 3019952
EMDN: -
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 09:33

Manufacturer products Authorised representative products Authorised representative actors View details

Cleaning liquid (Concentrated type)

Urinalysis Reagent

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794577269
Basic UDI-DI: 69257945W0101060299R0QZ
Reference: 3019971
EMDN: -
EMDN description: URINE TESTING - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 09:33

Manufacturer products Authorised representative products Authorised representative actors View details

CS-ISE Detergent

Chemistry Reagent

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794577153
Basic UDI-DI: 69257945W01010399R02C
Reference: 3019956
EMDN: -
EMDN description: ELECTROLYTES - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 09:33

Manufacturer products Authorised representative products Authorised representative actors View details

CS-Alkaline Detergent

Chemistry Reagent

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794577146
Basic UDI-DI: 69257945W01019099R04Y
Reference: 3019925
EMDN: -
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 09:33

Manufacturer products Authorised representative products Authorised representative actors View details

Urine Sediment Analyzer Reagent Diluent

Urinalysis Reagent

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794576477
Basic UDI-DI: 69257945W010106020302R0FD
Reference: 3007269
EMDN: -
EMDN description: URINE SEDIMENT TEST KIT (AUTOMATED)
First on market country: Hungary
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 09:33

Manufacturer products Authorised representative products Authorised representative actors View details

BSP-800 Automated Hematology Smear Slide Processor

BSP-800

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794575685
Basic UDI-DI: 69257945W0202059002D0QR
Reference: 3019712
EMDN: -
EMDN description: AUTOMATED SLIDE STAINERS
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 09:33

Manufacturer products Authorised representative products Authorised representative actors View details

Sample Pretreatment Reagent

Chemiluminescence Immunoassay Reagent

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794524553
Basic UDI-DI: 69257945W01029003R02L
Reference: 3016190
EMDN: -
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 09:33

Manufacturer products Authorised representative products Authorised representative actors View details

CM-320 Chemiluminescence Immunoassay Analyzer

CM-320

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794520043
Basic UDI-DI: 69257945W0201020104D0KF
Reference: 3013359
EMDN: -
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HIGH ROUTINE (Throughput > 700 test/h)
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 09:33

Manufacturer products Authorised representative products Authorised representative actors View details

CM-320i Chemiluminescence Immunoassay Analyzer

CM-320i

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794520036
Basic UDI-DI: 69257945W0201020103D0KA
Reference: 3013370
EMDN: -
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h)
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 09:33

Manufacturer products Authorised representative products Authorised representative actors View details

CS-2000i

CS-2000 CS-2000i

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794520012
Basic UDI-DI: 69257945W0201010104D0JW
Reference: 3012225
EMDN: -
EMDN description: CHEMISTRY ANALYSERS - HIGH ROUTINE (Random access without ISE mode test/h > 1.200)
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 09:33

Manufacturer products Authorised representative products Authorised representative actors View details

LA-60 Sample Processing System

LA-60

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794519856
Basic UDI-DI: 69257945W02060101D0YE
Reference: 3016285
EMDN: -
EMDN description: AUTOMATED SYSTEMS FOR THE MANAGEMENT OF PRE AND POST-ANALYSIS
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 09:33

Manufacturer products Authorised representative products Authorised representative actors View details

CM-180 Chemiluminescence Immunoassay Analyzer

CM-180

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794515025
Basic UDI-DI: 69257945W0201020102D0K5
Reference: 3015506
EMDN: -
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Romania
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 09:33

Manufacturer products Authorised representative products Authorised representative actors View details

BCA-1000 Automatic Blood Coagulation Analyzer

BCA-1000 BCA-3000

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794515001
Basic UDI-DI: 69257945W0202020102D0KU
Reference: 3009736
EMDN: -
EMDN description: AUTOMATED COAGULOMETERS
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 09:33

Manufacturer products Authorised representative products Authorised representative actors View details

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: -
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: 02.07.2026 09:33

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: -
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: 02.07.2026 09:33

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: -
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: 02.07.2026 09:33

Manufacturer products Authorised representative products Authorised representative actors View details

Probe Cleanser(BCC-3000)

Hematology Reagent

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794501684
Basic UDI-DI: 69257945W0103010105R0LU
Reference: 3002433
EMDN: -
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Poland
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 09:33

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: -
EMDN description: SEMI-AUTOMATED URINE ANALYSERS
First on market country: Poland
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 09:33

Manufacturer products Authorised representative products Authorised representative actors View details

Urinalysis Strips

IVD generalNot specifiedOn the market

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 16925794514827
Basic UDI-DI: B-16925794514827
Reference: 3008634
EMDN: -
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (AUTOMATED)
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 29.06.2026 13:21

Manufacturer products Authorised representative products Authorised representative actors View details

Urinalysis Strips

IVD generalNot specifiedOn the market

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 16925794514834
Basic UDI-DI: B-16925794514834
Reference: 3008642
EMDN: -
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (AUTOMATED)
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 29.06.2026 13:21

Manufacturer products Authorised representative products Authorised representative actors View details