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244 device results listed.

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Creatine Kinase MB Isoenzyme (CK-MB) Test Kit (Quantum Dots Fluorescence Immunochromatography)

A4402CL, A4402CV, A4403CC, A4403CV, A4404CC, A4402CC

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingReagentSingle use

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
UDI-DI: 06973315736947
Basic UDI-DI: B-06973315736947
Reference: A4402CV
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 17:02

Manufacturer products Authorised representative products Authorised representative actors View details

High Sensitivity Cardiac Troponin T (hs-cTnT) Test Kit (Quantum Dots Fluorescence Immunochromatography)

A8402CV

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
UDI-DI: 06973315736930
Basic UDI-DI: B-06973315736930
Reference: A8402CV
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 17:02

Manufacturer products Authorised representative products Authorised representative actors View details

D-Dimer Test Kit (Quantum Dots Fluorescence Immunochromatography)

D2402CV

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingReagentSingle use

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
UDI-DI: 06973315736923
Basic UDI-DI: B-06973315736923
Reference: D2402CV
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 17:02

Manufacturer products Authorised representative products Authorised representative actors View details

Brain Natriuretic Peptide (BNP) Test Kit (Quantum Dots Fluorescence Immunochromatography)

A7402CL, A7403CV, A7402CV, A7402CC, A7404CC, A7403CC

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingReagentSingle use

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
UDI-DI: 06973315736916
Basic UDI-DI: B-06973315736916
Reference: A7402CV
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 17:01

Manufacturer products Authorised representative products Authorised representative actors View details

High Sensitivity Cardiac Troponin I (hs-cTnI) Test Kit (Quantum Dots Fluorescence Immunochromatography)

A6402CL, A6403CV, A6402CV, A6402CC, A6404CC, A6403CC

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingReagentSingle use

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
UDI-DI: 06973315736909
Basic UDI-DI: B-06973315736909
Reference: A6402CV
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 17:01

Manufacturer products Authorised representative products Authorised representative actors View details

Interleukin 6 (IL-6) Test Kit (Quantum Dots Fluorescence Immunochromatography)

C4402CL, C4403CV, C4402CV, C4402CC, C4404CC, C4403CC

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingReagentSingle use

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
UDI-DI: 06973315736893
Basic UDI-DI: B-06973315736893
Reference: C4402CV
EMDN: W01030609
EMDN description: INTERLEUKIN 6 (IL-6)
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 17:01

Manufacturer products Authorised representative products Authorised representative actors View details

Procalcitonin (PCT) Test Kit (Quantum Dots Fluorescence Immunochromatography)

C1402CL, C1403CV, C1402CV, C1402CC, C1404CC, C1403CC

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingReagentSingle use

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
UDI-DI: 06973315736879
Basic UDI-DI: B-06973315736879
Reference: C1402CV
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 17:01

Manufacturer products Authorised representative products Authorised representative actors View details

Full-Scale C-Reactive Protein (CRP) Test Kit (Quantum Dots Fluorescence Immunochromatography)

C2402CL, C2403CV, C2402CV, C2402CC, C2404CC, C2403CC

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingReagentSingle use

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
UDI-DI: 06973315736886
Basic UDI-DI: B-06973315736886
Reference: C2402CV
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 17:01

Manufacturer products Authorised representative products Authorised representative actors View details

Quality Control (TSH/FT3/FT4)

L7801Q, L7802Q

IVD generalIVDDOn the marketMicrobial substancesNear-patient testingReagentSingle use

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
UDI-DI: 06973315736794
Basic UDI-DI: B-06973315736794
Reference: L7801Q
EMDN: W01021521
EMDN description: MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 17:01

Manufacturer products Authorised representative products Authorised representative actors View details

Quality Control (TT3/TT4)

L6801Q, L6802Q

IVD generalIVDDOn the marketNear-patient testingReagentSingle use

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
UDI-DI: 06973315736800
Basic UDI-DI: B-06973315736800
Reference: L6801Q
EMDN: W01021521
EMDN description: MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 17:01

Manufacturer products Authorised representative products Authorised representative actors View details

Thyroid Stimulating Hormone (TSH) Test Kit

L3402CV

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
UDI-DI: 06973315734691
Basic UDI-DI: B-06973315734691
Reference: L3402CV
EMDN: W01020410
EMDN description: THYROID STIMULATING HORMONE
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 06.07.2026 17:01

Manufacturer products Authorised representative products Authorised representative actors View details

Total Thyroxine (TT4) Test Kit

L2402CV

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
UDI-DI: 06973315734684
Basic UDI-DI: B-06973315734684
Reference: L2402CV
EMDN: W01020407
EMDN description: THYROXINE
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 06.07.2026 17:01

Manufacturer products Authorised representative products Authorised representative actors View details

Total Triiodothyronine (TT3) Test Kit

L1402CV

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
UDI-DI: 06973315734677
Basic UDI-DI: B-06973315734677
Reference: L1402CV
EMDN: W01020405
EMDN description: TRIIODOTHYRONINE
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 06.07.2026 17:01

Manufacturer products Authorised representative products Authorised representative actors View details

Free Thyroxine (FT4) Test Kit

L5402CV

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
UDI-DI: 06973315734660
Basic UDI-DI: B-06973315734660
Reference: L5402CV
EMDN: W01020402
EMDN description: FREE THYROXINE
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 06.07.2026 17:01

Manufacturer products Authorised representative products Authorised representative actors View details

Free Triiodothyronine (FT3) Test Kit

L4402CV

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
UDI-DI: 06973315734653
Basic UDI-DI: B-06973315734653
Reference: L4402CV/L4403CV/L4402CC/L4404CC/L4403CC
EMDN: W01020401
EMDN description: FREE TRIIODOTHYRONINE
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 06.07.2026 17:01

Manufacturer products Authorised representative products Authorised representative actors View details

2019-nCoV IgG/IgM Detection Kit (Colloidal Gold-Based）

C6603C

IVD generalIVDDOn the marketKitReagent

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
UDI-DI: 06973315730747
Basic UDI-DI: B-06973315730747
Reference: C6603C
EMDN: W0105090502
EMDN description: CORONAVIRUS ANTIBODY (AB) - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 17:01

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 and Influenza A/B Virus Antigen Combined Detection Kit (Colloidal Gold-Based)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
UDI-DI: 06973315730570
Basic UDI-DI: B-06973315730570
Reference: C9602CA
EMDN: W0105090601
EMDN description: CORONAVIRUS / INFLUENZA - RT & POC
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 06.07.2026 17:01

Manufacturer products Authorised representative products Authorised representative actors View details

Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antigen Detection Kit (Colloidal Gold-Based)

C8611C

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
UDI-DI: 06973315730518
Basic UDI-DI: B-06973315730518
Reference: C8611C
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 06.07.2026 17:01

Manufacturer products Authorised representative products Authorised representative actors View details

Novel Coronavirus (SARS-CoV-2) and Influenza A/B Virus RT-qPCR Detection Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
UDI-DI: 06973315730341
Basic UDI-DI: B-06973315730341
Reference: CD502
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 06.07.2026 17:01

Manufacturer products Authorised representative products Authorised representative actors View details

Vazyme Precision CS18 Dx Panel

NC354ME-C1

IVD Class AIVDR 2017/746On the marketMicrobial substancesProfessional testingReagent

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
UDI-DI: 06979469760333
Basic UDI-DI: 6979469760333M7
Reference: NC354ME-C1
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 03.07.2026 00:44

Manufacturer products Authorised representative products Authorised representative actors View details