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Human Sex Hormone-binding Globulin Detection Kit (Chemiluminescence Immunoassay)

1×100 Tests/kit, 1×50 Tests/kit, 2×50 Tests/kit

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794588685
Basic UDI-DI: 69257945W0102050109R0NV
Reference: 3013889
EMDN: -
EMDN description: SEX HORMONE BINDING GLOBULIN
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 02.07.2026 09:33

Manufacturer products Authorised representative products Authorised representative actors View details

Alpha-fetoprotein Detection Kit (Chemiluminescence Immunoassay)

1×100 Tests/kit, 1×50 Tests/kit, 2×50 Tests/kit

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794588562
Basic UDI-DI: 69257945W0102039001R0PV
Reference: 3013790
EMDN: -
EMDN description: ALPHAFETOPROTEIN
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 02.07.2026 09:33

Manufacturer products Authorised representative products Authorised representative actors View details

Free Triiodothyronine Detection Kit (Chemiluminescence Immunoassay)

1×100 Tests/kit, 1×50 Tests/kit, 2×50 Tests/kit

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794588449
Basic UDI-DI: 69257945W01020401R0XW
Reference: 3013860
EMDN: -
EMDN description: FREE TRIIODOTHYRONINE
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 02.07.2026 09:33

Manufacturer products Authorised representative products Authorised representative actors View details

Cancer Antigen 19-9 Detection Kit (Chemiluminescence Immunoassay)

1×100 Tests/kit, 1×50 Tests/kit, 2×50 Tests/kit

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794588302
Basic UDI-DI: 69257945W0102030103R0LV
Reference: 3013798
EMDN: -
EMDN description: CANCER ANTIGEN 19-9
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 02.07.2026 09:33

Manufacturer products Authorised representative products Authorised representative actors View details

BF-WFF Dye

Hematology Reagent

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794577641
Basic UDI-DI: 69257945W0103010199R0PF
Reference: 3019941
EMDN: -
EMDN description: REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - 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

FE Dye

1. Dye A: 1×50mL/bottle; Dye B: 1× 50mL/bottle 2. Dye A: 1×100mL/bottle, Dye B: 1×100mL/bottle 3. Dye A: 1×200mL/bottle, Dye B: 1×200mL/bottle 4. Dye A: 1×400mL/bottle, Dye B: 1×400mL/bottle 5. Dye A: 1×500mL/bottle, Dye B: 1×500mL/bottle

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794577580
Basic UDI-DI: 69257945W01030702R0ZM
Reference: 3019942
EMDN: -
EMDN description: CYTOCHEMICAL STAINING REAGENTS
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 Diluent

Blood Coagulation

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794577542
Basic UDI-DI: 69257945W0103020903R0PT
Reference: 3019961
EMDN: -
EMDN description: BUFFERS (HAEMOSTASIS)
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

Automatic Blood Coagulation Analyzer Detergent II

Automatic Blood Coagulation Analyzer Detergent

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794577511
Basic UDI-DI: 69257945W0103020999R0SQ
Reference: 3019962
EMDN: -
EMDN description: AUXILIARY REAGENTS (HAEMOSTASIS) - 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

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