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Clinical Chemistry Control

Level 2: 1×5mL

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202228575
Basic UDI-DI: B-06942202228575
Reference: 3025045
EMDN: W0101050199
EMDN description: MULTICOMPONENT CONTROLS (CC) - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 03.08.2026 16:57

Manufacturer products Authorised representative products Authorised representative actors View details

Clinical Chemistry Control

Level 1: 4×5mL

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202228568
Basic UDI-DI: B-06942202228568
Reference: 3024985
EMDN: W0101050199
EMDN description: MULTICOMPONENT CONTROLS (CC) - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 03.08.2026 16:57

Manufacturer products Authorised representative products Authorised representative actors View details

DIRUI

Level 1：1×5mL

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagentSingle use

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202228551
Basic UDI-DI: B-06942202228551
Reference: Level 1：1×5mL
EMDN: W0101050399
EMDN description: CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 03.08.2026 16:57

Manufacturer products Authorised representative products Authorised representative actors View details

DIRUI

Level 1：1×5mL

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagentSingle use

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202228537
Basic UDI-DI: B-06942202228537
Reference: Level 1：1×5mL
EMDN: W0101050399
EMDN description: CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 03.08.2026 16:57

Manufacturer products Authorised representative products Authorised representative actors View details

ISE blood quality control

High: Dissolved liquid: 4mL×1bottle，Freeze-dried powder: 0.18g×1bottle

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202226526
Basic UDI-DI: B-06942202226526
Reference: 3024572
EMDN: W0101050199
EMDN description: MULTICOMPONENT CONTROLS (CC) - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 16:54

Manufacturer products Authorised representative products Authorised representative actors View details

ISE blood quality control

IVD generalNot specifiedOn the market

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202226519
Basic UDI-DI: B-06942202226519
Reference: 3024568
EMDN: W0101050199
EMDN description: MULTICOMPONENT CONTROLS (CC) - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 16:52

Manufacturer products Authorised representative products Authorised representative actors View details

ISE blood sample calibrator

IVD generalNot specifiedOn the market

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202226502
Basic UDI-DI: B-06942202226502
Reference: 3024567
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 16:52

Manufacturer products Authorised representative products Authorised representative actors View details

ISE Internal Standard Solution

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202226465
Basic UDI-DI: B-06942202226465
Reference: 3024569
EMDN: W01010399
EMDN description: ELECTROLYTES - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 16:52

Manufacturer products Authorised representative products Authorised representative actors View details

ISE Reference Solution

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202226458
Basic UDI-DI: B-06942202226458
Reference: 3024564
EMDN: W01010399
EMDN description: ELECTROLYTES - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 16:52

Manufacturer products Authorised representative products Authorised representative actors View details

GLYCOHEMOGLOBIN A 1C REAGENT KIT

R1:1×30mL,R2：1×10mL ，Diluent: 7mL,Calibration sample: 5x1mL,

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202226342
Basic UDI-DI: B-06942202226342
Reference: 3009801
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 16:51

Manufacturer products Authorised representative products Authorised representative actors View details

GLYCOHEMOGLOBIN A 1C REAGENT KIT

R1:1×30mL,R2：1×10mL

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202226335
Basic UDI-DI: B-06942202226335
Reference: 3024548
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 16:51

Manufacturer products Authorised representative products Authorised representative actors View details

TOTAL BILIRUBIN REAGENT KIT(SURFACTANT/DIAZO SALT METHOD)

R1: 12x20mL, R2: 1x5mL，Calibration sample: 2mL

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202226328
Basic UDI-DI: B-06942202226328
Reference: 3024547
EMDN: W01010203
EMDN description: BILIRUBIN
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 16:51

Manufacturer products Authorised representative products Authorised representative actors View details

DIRECT BILIRUBIN REAGENT KIT(DIAZO SALT METHOD)

R1: 12x20mL, R2: 1x3mL，Calibration sample: 2mL

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202226311
Basic UDI-DI: B-06942202226311
Reference: 3024549
EMDN: W01010203
EMDN description: BILIRUBIN
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 16:51

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine Kinase MB Detection Kit (Chemiluminescence Immunoassay)

2×50 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202224065
Basic UDI-DI: B-06942202224065
Reference: 3013914
EMDN: W01010115
EMDN description: CREATINE KINASE ISOENZYMES
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 16:50

Manufacturer products Authorised representative products Authorised representative actors View details

Thyroglobulin Detection Kit (Chemiluminescence Immunoassay)

2×50 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202223891
Basic UDI-DI: B-06942202223891
Reference: 3013871
EMDN: W01010231
EMDN description: TRIGLYCERIDES
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 16:50

Manufacturer products Authorised representative products Authorised representative actors View details

GLYCOHEMOGLOBIN A 1C REAGENT KIT

R1:1×30mL,R2:R2：1×10mL ，Diluent: 7mL,Calibration sample: 5x1mL, Control: 2x1mL

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202223549
Basic UDI-DI: B-06942202223549
Reference: 3009799
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 16:49

Manufacturer products Authorised representative products Authorised representative actors View details

Multi-Calibrator for Urine Physical and Chemical Analysis

Calibrator level 3: 4×4mL

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202221804
Basic UDI-DI: B-06942202221804
Reference: 3024163
EMDN: W010106020602
EMDN description: URINE TESTING CALIBRATORS AND STANDARDS
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 16:49

Manufacturer products Authorised representative products Authorised representative actors View details

Multi-Calibrator for Urine Physical and Chemical Analysis

Calibrator level 2: 4×4mL

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202221798
Basic UDI-DI: B-06942202221798
Reference: 3024161
EMDN: W010106020602
EMDN description: URINE TESTING CALIBRATORS AND STANDARDS
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 16:49

Manufacturer products Authorised representative products Authorised representative actors View details

Multi-Calibrator for Urine Physical and Chemical Analysis

Calibrator level 1: 4×4mL

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202221781
Basic UDI-DI: B-06942202221781
Reference: 3024165
EMDN: W010106020602
EMDN description: URINE TESTING CALIBRATORS AND STANDARDS
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 16:49

Manufacturer products Authorised representative products Authorised representative actors View details

DIRECT BILIRUBIN REAGENT KIT(DIAZO SALT METHOD)

R1: 5x50mL, R2: 1x3mL，Calibration sample: 2mL

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202216084
Basic UDI-DI: B-06942202216084
Reference: 3023578
EMDN: W01010203
EMDN description: BILIRUBIN
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 16:49

Manufacturer products Authorised representative products Authorised representative actors View details