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FE CalibratorⅡ

1×60 mL

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794516626
Basic UDI-DI: B-06925794516626
Reference: 3009398
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 09:30

Manufacturer products Authorised representative products Authorised representative actors View details

FE Focus B II

1×60mL

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794516619
Basic UDI-DI: B-06925794516619
Reference: 3009373
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 09:30

Manufacturer products Authorised representative products Authorised representative actors View details

Urine Conductivity Analysis Control

Level 1：1×60mL/bottle; Level 2：1×60mL/bottle

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794515124
Basic UDI-DI: B-06925794515124
Reference: 3008160
EMDN: W010106020601
EMDN description: URINE TESTING CONTROLS
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:30

Manufacturer products Authorised representative products Authorised representative actors View details

Urine Conductivity Analysis Calibrator

Level 1：1×3mL/bottle; Level 2：1×3mL/bottle; Level 3：1×3mL/bottle.

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794514875
Basic UDI-DI: B-06925794514875
Reference: 3008146
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 09:30

Manufacturer products Authorised representative products Authorised representative actors View details

FE Multi Control

Level 1: 1×10mL/bottle; Level 3: 1×10mL/bottle

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794514325
Basic UDI-DI: B-06925794514325
Reference: 3006183
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:30

Manufacturer products Authorised representative products Authorised representative actors View details

Vaginal Secretions Analysis Control

Negative: 10× 1.0mL/bottle; Positive:10× 1.0mL/bottle

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794514080
Basic UDI-DI: B-06925794514080
Reference: 3006198
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:30

Manufacturer products Authorised representative products Authorised representative actors View details

FE Control

Negative control: 1×60 mL

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794513335
Basic UDI-DI: B-06925794513335
Reference: 3006334
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:30

Manufacturer products Authorised representative products Authorised representative actors View details

FE Control

Level 3 of positive control: 1×60 mL

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794513281
Basic UDI-DI: B-06925794513281
Reference: 3006329
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:30

Manufacturer products Authorised representative products Authorised representative actors View details

FE Focus B

IVD generalNot specifiedOn the market

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794513137
Basic UDI-DI: B-06925794513137
Reference: 3006314
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:29

Manufacturer products Authorised representative products Authorised representative actors View details

FE Calibrator

1×15 mL

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794513007
Basic UDI-DI: B-06925794513007
Reference: 3006338
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:29

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine Kinase MB Detection Kit (Chemiluminescence Immunoassay)

1×100 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794511904
Basic UDI-DI: B-06925794511904
Reference: 3008767
EMDN: W01010115
EMDN description: CREATINE KINASE ISOENZYMES
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:29

Manufacturer products Authorised representative products Authorised representative actors View details

Thyroglobulin Detection Kit (Chemiluminescence Immunoassay)

1×100 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794511805
Basic UDI-DI: B-06925794511805
Reference: 3008737
EMDN: W01010231
EMDN description: TRIGLYCERIDES
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:29

Manufacturer products Authorised representative products Authorised representative actors View details

Kit for Urine Sediment Analyzer

125ml×4 (Including 1 Negative Control, 1 Positive Control, 1 Standard Solution and 1 Focus)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794505286
Basic UDI-DI: B-06925794505286
Reference: 232030203201
EMDN: W010106020302
EMDN description: URINE SEDIMENT TEST KIT (AUTOMATED)
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:29

Manufacturer products Authorised representative products Authorised representative actors View details

Urinalysis Control

8ml/bottle (Negative)

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794505033
Basic UDI-DI: B-06925794505033
Reference: 232030301201
EMDN: W010106020601
EMDN description: URINE TESTING CONTROLS
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:29

Manufacturer products Authorised representative products Authorised representative actors View details

Urinalysis Control

8ml/bottle (Positive)

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794505019
Basic UDI-DI: B-06925794505019
Reference: 232030303201
EMDN: W010106020601
EMDN description: URINE TESTING CONTROLS
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:29

Manufacturer products Authorised representative products Authorised representative actors View details

H series urine analyzer Control liquid for Specific gravity

8ml/vial （1.050）

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794504265
Basic UDI-DI: B-06925794504265
Reference: 232030101203
EMDN: W010106020601
EMDN description: URINE TESTING CONTROLS
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:28

Manufacturer products Authorised representative products Authorised representative actors View details

H series urine analyzer Control liquid for Specific gravity

8ml/vial （1.030）

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794504258
Basic UDI-DI: B-06925794504258
Reference: 232030101202
EMDN: W010106020601
EMDN description: URINE TESTING CONTROLS
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:28

Manufacturer products Authorised representative products Authorised representative actors View details

H series urine analyzer Control liquid for Specific gravity

8ml/vial （1.005）

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794504241
Basic UDI-DI: B-06925794504241
Reference: 232030101201
EMDN: W010106020601
EMDN description: URINE TESTING CONTROLS
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:28

Manufacturer products Authorised representative products Authorised representative actors View details

H series urine analyzer Calibration liquid for Specific gravity

8ml/vial （1.040）

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794504234
Basic UDI-DI: B-06925794504234
Reference: 232030101204
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 09:28

Manufacturer products Authorised representative products Authorised representative actors View details

H series urine analyzer Control liquid for Turbidity

8ml/vial（200NTU）

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794504210
Basic UDI-DI: B-06925794504210
Reference: 232030104201
EMDN: W010106020601
EMDN description: URINE TESTING CONTROLS
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:28

Manufacturer products Authorised representative products Authorised representative actors View details