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Diagnostic Kit for cTnI/Myo/CK-MB (Time-resolved Fluorescence Immunochromatographic Assay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521000563
Basic UDI-DI: B-06974521000563
Reference: SUPF025025
EMDN: W01021499
EMDN description: MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:27

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Kit for C-reactive Protein /Serum Amyloid A (Time-resolved Fluorescence Immunochromatographic Assay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521000556
Basic UDI-DI: B-06974521000556
Reference: SUPF006025
EMDN: W01021499
EMDN description: MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:27

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Kit for C-reactive Protein (hsCRP&CRP) (Time-resolved Fluorescence Immunochromatographic assay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521000549
Basic UDI-DI: B-06974521000549
Reference: SUPF008025
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:27

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Kit for Cortisol (Time-resolved Fluorescence Immunochromatographic Assay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521000532
Basic UDI-DI: B-06974521000532
Reference: SUPF089025
EMDN: W0102060203
EMDN description: CORTISOL
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:27

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Kit for CK-MB (Time-resolved Fluorescence Immunochromatographic Assay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521000525
Basic UDI-DI: B-06974521000525
Reference: SUPF019025
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:27

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Kit for Cardiac Troponin T (Time-resolved Fluorescence Immunochromatographic Assay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521000518
Basic UDI-DI: B-06974521000518
Reference: SUPF026025
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:27

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Kit for Cardiac Troponin I (cTnI) (Time-resolved Fluorescence Immunochromatographic Assay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521000501
Basic UDI-DI: B-06974521000501
Reference: SUPF013025
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:27

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Kit for BNP (Time-resolved Fluorescence Immunochromatographic Assay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521000495
Basic UDI-DI: B-06974521000495
Reference: SUPF027025
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:27

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Kit for Anti-Müllerian Hormone (AMH) (Time-resolved Fluorescence Immunochromatographic Assay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521000488
Basic UDI-DI: B-06974521000488
Reference: SUPF030025
EMDN: W0102050215
EMDN description: ANTI-MÛLLERIAN HORMONE
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:27

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Kit for 25-HydroxyvitaminD (25-OH-VD) (Time-resolved Fluorescence Immunochromatographic Assay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521000471
Basic UDI-DI: B-06974521000471
Reference: SUPF031025
EMDN: W0102070206
EMDN description: VITAMIN D (CHOLECALCIFEROL)
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:27

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Kit for 2019-Novel Coronavirus(2019-nCoV) Ag Test (Fluorescence Immunochromatographic Assay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521000464
Basic UDI-DI: B-06974521000464
Reference: SUPF044025
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:27

Manufacturer products Authorised representative products Authorised representative actors View details

D-Dimer/ cTnI/ NT-proBNP Control

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521000457
Basic UDI-DI: B-06974521000457
Reference: QC109
EMDN: W01021521
EMDN description: MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:27

Manufacturer products Authorised representative products Authorised representative actors View details

D-Dimer Control

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521000440
Basic UDI-DI: B-06974521000440
Reference: QC103
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Iceland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:27

Manufacturer products Authorised representative products Authorised representative actors View details

cTnT Control

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521000433
Basic UDI-DI: B-06974521000433
Reference: QC106
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:26

Manufacturer products Authorised representative products Authorised representative actors View details

cTnI Control

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521000426
Basic UDI-DI: B-06974521000426
Reference: QC101
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:26

Manufacturer products Authorised representative products Authorised representative actors View details

CRP/SAA Control

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521000419
Basic UDI-DI: B-06974521000419
Reference: QC404
EMDN: W01021521
EMDN description: MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:26

Manufacturer products Authorised representative products Authorised representative actors View details

Cortisol Control

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521000396
Basic UDI-DI: B-06974521000396
Reference: QC317
EMDN: W0102152008
EMDN description: CONTROLS FOR INDIVIDUAL AND SPECIFIC HORMONES
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:26

Manufacturer products Authorised representative products Authorised representative actors View details

AMH Control

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521000389
Basic UDI-DI: B-06974521000389
Reference: QC309
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:26

Manufacturer products Authorised representative products Authorised representative actors View details

25-OH-VD Control

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521000372
Basic UDI-DI: B-06974521000372
Reference: QC701
EMDN: W0102152006
EMDN description: ANAEMIA RELATED/VITAMIN CONTROLS
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:26

Manufacturer products Authorised representative products Authorised representative actors View details

Multi-Drug Test Card (Colloidal Gold)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521000365
Basic UDI-DI: B-06974521000365
Reference: SUPG239025
EMDN: W0102090199
EMDN description: DRUGS OF ABUSE - OTHER
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:26

Manufacturer products Authorised representative products Authorised representative actors View details