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524 device results listed.

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Des-Gamma-Carboxy Prothrombin Test Kit (FIA)

VID136

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID136F2
Basic UDI-DI: B-VID136F2
Reference: VID136-06-011
EMDN: W0103020101
EMDN description: PROTHROMBIN TIME ( QUICK TEST )
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:20

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Myxovirus Resistance Protein A Test Kit (FIA)

VID137

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID137F4
Basic UDI-DI: B-VID137F4
Reference: VID137-01-011
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:20

Manufacturer products Authorised representative products Authorised representative actors View details

Heart Fatty Acid Binding Protein Test Kit (FIA)

VID13

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID132Q
Basic UDI-DI: B-VID132Q
Reference: VID13-03-011
EMDN: W0102160705
EMDN description: HEART-TYPE FATTY ACID-BINDING PROTEIN - RT & POC
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:20

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VivaDiag Herpes Simplex Virus Type 1 IgG Test Kit (FIA)

VID133

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID133EU
Basic UDI-DI: B-VID133EU
Reference: VID133-01-011
EMDN: W0105040306
EMDN description: HSV 1 IGG
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:20

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VivaDiag Synthetic Marijuana K3 Test Kit (FIA)

VID130

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID130EN
Basic UDI-DI: B-VID130EN
Reference: VID130-09-011
EMDN: W0102090299
EMDN description: TOXICOLOGY - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:20

Manufacturer products Authorised representative products Authorised representative actors View details

VivaDiag Folate Test Kit (FIA)

VID129

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID129F5
Basic UDI-DI: B-VID129F5
Reference: VID129-07-011
EMDN: W0102070103
EMDN description: FOLATE
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:20

Manufacturer products Authorised representative products Authorised representative actors View details

VivaDiag Vitamin B12 Test Kit (FIA)

VID128

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID128F3
Basic UDI-DI: B-VID128F3
Reference: VID128-07-011
EMDN: W0102070204
EMDN description: VITAMIN B12
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:20

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VivaDiag Tacrolimus Test Kit (FIA)

VID127

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID127EZ
Basic UDI-DI: B-VID127EZ
Reference: VID127-13-011
EMDN: W0102080603
EMDN description: TACROLIMUS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:20

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VivaDiag Cyclosporin A Test Kit (FIA)

VID126

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID126EX
Basic UDI-DI: B-VID126EX
Reference: VID126-13-011
EMDN: W0102080602
EMDN description: CYCLOSPORINE SPECIFIC
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:20

Manufacturer products Authorised representative products Authorised representative actors View details

Myoglobin Test Kit (FIA)

VID12

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID122N
Basic UDI-DI: B-VID122N
Reference: VID12-03-011
EMDN: W0102160702
EMDN description: MYOGLOBIN - RT & POC
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:20

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-cyclic Citrullinated Peptide Antibody Test Kit (FIA)

VID119

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID119F2
Basic UDI-DI: B-VID119F2
Reference: VID119-01-011
EMDN: W01021112
EMDN description: ANTI-CYCLIC CITRULLINATED PEPTIDE
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:20

Manufacturer products Authorised representative products Authorised representative actors View details

Cytokeratin 19 Fragment (CYFRA21-1) Test Kit (FIA)

VID117

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID117EW
Basic UDI-DI: B-VID117EW
Reference: VID117-06-011
EMDN: W0102030126
EMDN description: CYTOKERATINS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:20

Manufacturer products Authorised representative products Authorised representative actors View details

Monkeypox Virus IgM/IgG Test Kit (FIA)

VID114

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID114EQ
Basic UDI-DI: B-VID114EQ
Reference: VID114-01-011
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:20

Manufacturer products Authorised representative products Authorised representative actors View details

VivaDiag High Sensitive Cardiac Troponin I Test Kit (FIA)

VID113

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID113EN
Basic UDI-DI: B-VID113EN
Reference: VID113-03-011
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:20

Manufacturer products Authorised representative products Authorised representative actors View details

D-Dimer Test Kit (FIA)

VID11

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID112L
Basic UDI-DI: B-VID112L
Reference: VID11-03-011
EMDN: W0103020803
EMDN description: D-DIMER - RT & POC
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:20

Manufacturer products Authorised representative products Authorised representative actors View details

VivaDiag Rotavirus/Adenovirus Test Kit (FIA)

VID112

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID112EL
Basic UDI-DI: B-VID112EL
Reference: VID112-01-011
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:20

Manufacturer products Authorised representative products Authorised representative actors View details

VivaDiag Influenza A+B/RSV Test Kit (FIA)

VID111

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID111EJ
Basic UDI-DI: B-VID111EJ
Reference: VID111-01-011
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:20

Manufacturer products Authorised representative products Authorised representative actors View details

VivaDiag Infection Combo (SAA/CRP) Test Kit (FIA)

VID110

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID110EG
Basic UDI-DI: B-VID110EG
Reference: VID110-01-011
EMDN: W0102069099
EMDN description: INDIVIDUAL AND SPECIFIC HORMONES - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:20

Manufacturer products Authorised representative products Authorised representative actors View details

VivaDiag Infection Combo (PCT/IL-6/CRP) Test Kit (FIA)

VID109

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID109EX
Basic UDI-DI: B-VID109EX
Reference: VID109-01-011
EMDN: W0102069099
EMDN description: INDIVIDUAL AND SPECIFIC HORMONES - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:20

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine Kinase-MB Test Kit (FIA)

VID10

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID102J
Basic UDI-DI: B-VID102J
Reference: VID10-03-011
EMDN: W0102160701
EMDN description: CREATINE KINASE - MB MASS - RT & POC
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:20

Manufacturer products Authorised representative products Authorised representative actors View details