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Clinical Chemistry Calibrator

Level 1: 15×5mL

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202230660
Basic UDI-DI: B-06942202230660
Reference: 3025244
EMDN: W0101050399
EMDN description: CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 26.06.2026 15:06

Manufacturer products Authorised representative products Authorised representative actors View details

Clinical Chemistry Calibrator

Level 1: 10×5mL

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202230653
Basic UDI-DI: B-06942202230653
Reference: 3025193
EMDN: W0101050399
EMDN description: CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 26.06.2026 15:06

Manufacturer products Authorised representative products Authorised representative actors View details

Clinical Chemistry Calibrator

Level 1: 8×5mL

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202230646
Basic UDI-DI: B-06942202230646
Reference: 3025211
EMDN: W0101050399
EMDN description: CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 26.06.2026 15:06

Manufacturer products Authorised representative products Authorised representative actors View details

Clinical Chemistry Calibrator

Level 1: 6×5mL

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202230639
Basic UDI-DI: B-06942202230639
Reference: 3025210
EMDN: W0101050399
EMDN description: CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 26.06.2026 15:06

Manufacturer products Authorised representative products Authorised representative actors View details

Clinical Chemistry Calibrator

Level 1: 3×5mL

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202230622
Basic UDI-DI: B-06942202230622
Reference: 3025264
EMDN: W0101050399
EMDN description: CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 26.06.2026 15:05

Manufacturer products Authorised representative products Authorised representative actors View details

Clinical Chemistry Calibrator

Level 1: 2×5mL

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202230615
Basic UDI-DI: B-06942202230615
Reference: 3025192
EMDN: W0101050399
EMDN description: CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 26.06.2026 15:05

Manufacturer products Authorised representative products Authorised representative actors View details

06942202230172

R1: 5×5mL; R2: 5×5mL; D-Dimer Diluent:1×50mL; Calibrator: 1×1mL; Control Low value:1×1mL; Control High value: 1×1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202230172
Basic UDI-DI: B-06942202230172
Reference: R1: 5×5mL; R2: 5×5mL; D-Dimer Diluent:1×50mL; Calibrator: 1×1mL; Control Low value:1×1mL; Control High value: 1×1mL
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 26.06.2026 15:05

Manufacturer products Authorised representative products Authorised representative actors View details

Auto-Chemistry Analyzer

CS-650

IVD generalIVDDOn the marketInstrument

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202229800
Basic UDI-DI: B-06942202229800
Reference: CS-650
EMDN: W0201010102
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 26.06.2026 15:05

Manufacturer products Authorised representative products Authorised representative actors View details

Auto-Chemistry Analyzer

CS-450

IVD generalIVDDOn the marketInstrument

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202229794
Basic UDI-DI: B-06942202229794
Reference: CS-450
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 26.06.2026 15:05

Manufacturer products Authorised representative products Authorised representative actors View details

DIRUI

3x1mL

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202229619
Basic UDI-DI: B-06942202229619
Reference: 3003159
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 26.06.2026 15:05

Manufacturer products Authorised representative products Authorised representative actors View details

DIRUI

3x1mL

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202229602
Basic UDI-DI: B-06942202229602
Reference: 3003153
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 26.06.2026 15:05

Manufacturer products Authorised representative products Authorised representative actors View details

DIRUI

4x5mL

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202229596
Basic UDI-DI: B-06942202229596
Reference: 3001277
EMDN: W0101050199
EMDN description: MULTICOMPONENT CONTROLS (CC) - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 26.06.2026 15:05

Manufacturer products Authorised representative products Authorised representative actors View details

DIRUI

4x5mL

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202229589
Basic UDI-DI: B-06942202229589
Reference: 3001276
EMDN: W0101050199
EMDN description: MULTICOMPONENT CONTROLS (CC) - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 26.06.2026 15:05

Manufacturer products Authorised representative products Authorised representative actors View details

DIRUI

4x5mL

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202229572
Basic UDI-DI: B-06942202229572
Reference: 3001833
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 26.06.2026 15:05

Manufacturer products Authorised representative products Authorised representative actors View details

DIRUI

R1: 4x50ml, R2: 1x50ml

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202229565
Basic UDI-DI: B-06942202229565
Reference: 3000811
EMDN: W01010108
EMDN description: AMYLASE ISOENZYMES
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 26.06.2026 15:05

Manufacturer products Authorised representative products Authorised representative actors View details

DIRUI

R1: 1x60ml, R2: 1x17ml, Calibration sample: 2x0.5mL,Control: 1x0.5mL

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202229558
Basic UDI-DI: B-06942202229558
Reference: 3005504
EMDN: W01010299
EMDN description: SUBSTRATES - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 26.06.2026 15:05

Manufacturer products Authorised representative products Authorised representative actors View details

DIRUI

R1: 4x50ml, R2: 1x50ml

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202229541
Basic UDI-DI: B-06942202229541
Reference: 3000788
EMDN: W01010119
EMDN description: LACTATE DEHYDROGENASE L ( LDH - L --> P )
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 26.06.2026 15:05

Manufacturer products Authorised representative products Authorised representative actors View details

DIRUI

R1: 4x50ml, R2: 1x50ml

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202229534
Basic UDI-DI: B-06942202229534
Reference: 3000756
EMDN: W01010113
EMDN description: CREATINE KINASE - TOTAL
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 26.06.2026 15:05

Manufacturer products Authorised representative products Authorised representative actors View details

DIRUI

R1: 1x50ml, R2: 1x10ml, Calibration sample: 1x1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202229527
Basic UDI-DI: B-06942202229527
Reference: 3004615
EMDN: W0102010107
EMDN description: IMMUNOGLOBULIN M
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 26.06.2026 15:05

Manufacturer products Authorised representative products Authorised representative actors View details

DIRUI

R1: 1x50ml, R2: 1x10ml, Calibration sample: 1x1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202229510
Basic UDI-DI: B-06942202229510
Reference: 3004616
EMDN: W0102010105
EMDN description: IMMUNOGLOBULIN G
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 26.06.2026 15:05

Manufacturer products Authorised representative products Authorised representative actors View details