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Specific Protein Control

Level 2: 2×1mL

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202228667
Basic UDI-DI: B-06942202228667
Reference: 3025081
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
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

Specific Protein Control

Level 2: 1×1mL

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202228650
Basic UDI-DI: B-06942202228650
Reference: 3025046
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
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

Specific Protein Control

Level 1: 8×1mL

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202228643
Basic UDI-DI: B-06942202228643
Reference: 3024986
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
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

Specific Protein Control

Level 1: 6×1mL

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202228636
Basic UDI-DI: B-06942202228636
Reference: 3024968
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
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

Specific Protein Control

Level 1: 5×1mL

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202228629
Basic UDI-DI: B-06942202228629
Reference: 3025103
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
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 1:3×1mL

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagentSingle use

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202228612
Basic UDI-DI: B-06942202228612
Reference: Level 1:3×1mL
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
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

Specific Protein Control

Level 1: 2×1mL

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202228605
Basic UDI-DI: B-06942202228605
Reference: 3025012
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
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

Specific Protein Control

Level 1: 1×1mL

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202228599
Basic UDI-DI: B-06942202228599
Reference: 3025010
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
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

β2-Microglobulin Control

Type B：Low value：1×1mL High value：1×1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202223365
Basic UDI-DI: B-06942202223365
Reference: 3024314
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 03.08.2026 16:49

Manufacturer products Authorised representative products Authorised representative actors View details

β2-Microglobulin Control

Type B：Low value：1×0.5mL High value：1×0.5mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202223358
Basic UDI-DI: B-06942202223358
Reference: 3024307
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 03.08.2026 16:49

Manufacturer products Authorised representative products Authorised representative actors View details

β2-Microglobulin Control

Type A：Low value：1×1mL High value：1×1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202223341
Basic UDI-DI: B-06942202223341
Reference: 3024313
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 03.08.2026 16:49

Manufacturer products Authorised representative products Authorised representative actors View details

DIRUI

Type A：Low value：1×0.5mL, High value：1×0.5mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagentSingle use

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202223334
Basic UDI-DI: B-06942202223334
Reference: Type A：Low value：1×0.5mL, High value：1×0.5mL
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 03.08.2026 16:49

Manufacturer products Authorised representative products Authorised representative actors View details

β2-Microglobulin Calibrator

Type B：5×1mL（5levels）

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202223280
Basic UDI-DI: B-06942202223280
Reference: 3024317
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 03.08.2026 16:49

Manufacturer products Authorised representative products Authorised representative actors View details

β2-Microglobulin Calibrator

Type B：5×0.5mL（5levels）

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202223273
Basic UDI-DI: B-06942202223273
Reference: 3024318
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 03.08.2026 16:49

Manufacturer products Authorised representative products Authorised representative actors View details

β2-Microglobulin Calibrator

Type A：5×1mL（5levels）

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202223266
Basic UDI-DI: B-06942202223266
Reference: 3024273
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 03.08.2026 16:49

Manufacturer products Authorised representative products Authorised representative actors View details

DIRUI

Type A：5×0.5mmL（level 1, level 2, level 3, level 4, level 5）

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagentSingle use

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202223259
Basic UDI-DI: B-06942202223259
Reference: Type A：5×0.5mmL（level 1, level 2, level 3, level 4, level 5）
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 03.08.2026 16:49

Manufacturer products Authorised representative products Authorised representative actors View details

H-FABP Control

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802604557
Basic UDI-DI: B-06926802604557
Reference: MCL04901E
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Netherlands
Authorised representative: R Sight B.V.
Last updated: 03.08.2026 11:07

Manufacturer products Authorised representative products Authorised representative actors View details

Lp-PLA2 Control

IVD generalIVDDOn the marketMicrobial substancesProfessional testingReagent

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802604540
Basic UDI-DI: B-06926802604540
Reference: MCL04801E
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Netherlands
Authorised representative: R Sight B.V.
Last updated: 03.08.2026 11:07

Manufacturer products Authorised representative products Authorised representative actors View details

sST2 Control

IVD generalIVDDOn the marketMicrobial substancesProfessional testingReagent

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802604533
Basic UDI-DI: B-06926802604533
Reference: MCL04701E
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Netherlands
Authorised representative: R Sight B.V.
Last updated: 03.08.2026 11:07

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-CCP Control

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802604526
Basic UDI-DI: B-06926802604526
Reference: MCL04601E
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Netherlands
Authorised representative: R Sight B.V.
Last updated: 03.08.2026 11:07

Manufacturer products Authorised representative products Authorised representative actors View details