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EUDAMED Device Search

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SmarLumi

Cardiac Troponin T (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289858489
Basic UDI-DI: B-06933289858489
Reference: WA01P0007
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 05.08.2026 14:22

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Cardiac Troponin T (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289858472
Basic UDI-DI: B-06933289858472
Reference: WA01P0006
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 05.08.2026 14:22

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289858465
Basic UDI-DI: B-06933289858465
Reference: WA01P0005
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 05.08.2026 14:20

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289858458
Basic UDI-DI: B-06933289858458
Reference: WA01P0004
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 05.08.2026 14:20

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Lipoprotein-Associated Phospholipase A2 (CLIA）

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289857710
Basic UDI-DI: B-06933289857710
Reference: W387P0007
EMDN: W01021312
EMDN description: LIPOPROTEIN-ASSOCIATED PHOSPHOLIPASE A2
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 05.08.2026 14:19

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Lipoprotein-Associated Phospholipase A2 (CLIA）

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289857703
Basic UDI-DI: B-06933289857703
Reference: W387P0006
EMDN: W01021312
EMDN description: LIPOPROTEIN-ASSOCIATED PHOSPHOLIPASE A2
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 05.08.2026 14:19

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Lipoprotein-Associated Phospholipase A2 (CLIA）

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289857697
Basic UDI-DI: B-06933289857697
Reference: W387P0005
EMDN: W01021312
EMDN description: LIPOPROTEIN-ASSOCIATED PHOSPHOLIPASE A2
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 05.08.2026 14:19

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Lipoprotein-Associated Phospholipase A2 (CLIA）

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289857680
Basic UDI-DI: B-06933289857680
Reference: W387P0004
EMDN: W01021312
EMDN description: LIPOPROTEIN-ASSOCIATED PHOSPHOLIPASE A2
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 05.08.2026 14:19

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Myoglobin (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289857635
Basic UDI-DI: B-06933289857635
Reference: W384P0007
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 05.08.2026 14:19

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Myoglobin (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289857628
Basic UDI-DI: B-06933289857628
Reference: W384P0006
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 05.08.2026 14:19

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Myoglobin (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289857611
Basic UDI-DI: B-06933289857611
Reference: W384P0005
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 05.08.2026 14:19

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Myoglobin (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289857604
Basic UDI-DI: B-06933289857604
Reference: W384P0004
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 05.08.2026 14:19

Manufacturer products Authorised representative products Authorised representative actors View details

AURYX 90 CK-MB STAT Reagent Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: PZ CORMAY Spółka Akcyjna
Manufacturer SRN: PL-MF-000023053
UDI-DI: 05907514600588
Basic UDI-DI: B-05907514600588
Reference: I20-R0040
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Poland
Authorised representative: -
Last updated: 05.08.2026 13:59

Manufacturer products View details

AURYX 90 CK-MB STAT Reagent Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: PZ CORMAY Spółka Akcyjna
Manufacturer SRN: PL-MF-000023053
UDI-DI: 05907514600571
Basic UDI-DI: B-05907514600571
Reference: I20-R0039
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Poland
Authorised representative: -
Last updated: 05.08.2026 13:59

Manufacturer products View details

Diagnostic Kit for Myoglobin

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: MP Biomedicals Germany GmbH
Manufacturer SRN: DE-MF-000020991
UDI-DI: 04260163315939
Basic UDI-DI: B-04260163315939
Reference: 07MY5025
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 11:40

Manufacturer products View details

Diagnostic Kit for Myoglobin (Myo)

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: MP Biomedicals Germany GmbH
Manufacturer SRN: DE-MF-000020991
UDI-DI: 04260163315779
Basic UDI-DI: B-04260163315779
Reference: 07MY5025
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 11:39

Manufacturer products View details

Ischemic Modified Albumin Reagent Kit (ACB Assay)

R1: 1x30ml, R2: 1x10ml, Calibration sample: 2x1mL, Control: 1x1mL

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202239151
Basic UDI-DI: B-06942202239151
Reference: 3011606
EMDN: W01021399
EMDN description: CARDIAC MARKERS - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 05.08.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

Ischemic Modified Albumin Reagent Kit (ACB Assay)

R1: 1x30ml, R2: 1x10ml

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202239168
Basic UDI-DI: B-06942202239168
Reference: 3011744
EMDN: W01021399
EMDN description: CARDIAC MARKERS - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 05.08.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

High Sensitivity C-Reactive Protein Kit (Latex Immunoturbidimetric Assay)

R1: 1x60ml, R2: 1x20ml

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202238697
Basic UDI-DI: B-06942202238697
Reference: 3012186
EMDN: W01021308
EMDN description: HIGH-SENSITIVITY C-.REACTIVE PROTEIN
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 04.08.2026 22:54

Manufacturer products Authorised representative products Authorised representative actors View details

High Sensitivity C-Reactive Protein Kit (Latex Immunoturbidimetric Assay)

R1: 1x60ml, R2: 1x20ml, Calibration sample: 1x1mL, Control: 2x1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202238642
Basic UDI-DI: B-06942202238642
Reference: 3009794
EMDN: W01021308
EMDN description: HIGH-SENSITIVITY C-.REACTIVE PROTEIN
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 04.08.2026 22:54

Manufacturer products Authorised representative products Authorised representative actors View details