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242 device results listed.

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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

STI Sample Preservation Buffer

PSTI01C-01

IVD Class AIVDR 2017/746On the marketNear-patient testingProfessional testingSingle use

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
UDI-DI: 06979469760357
Basic UDI-DI: 6979469760357MM
Reference: PSTI01C-01
EMDN: W0104010204
EMDN description: SAMPLE TRANSPORT FOR NA TESTING
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 03.07.2026 00:43

Manufacturer products Authorised representative products Authorised representative actors View details

Vazyme Precision PN30 Dx Panel

NC353ME-C1

IVD Class AIVDR 2017/746On the marketMicrobial substancesProfessional testingReagent

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
UDI-DI: 06979469760340
Basic UDI-DI: 6979469760340M4
Reference: NC353ME-C1
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 03.07.2026 00:43

Manufacturer products Authorised representative products Authorised representative actors View details

DNA/RNA Extraction Kit

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
UDI-DI: 06973315739870
Basic UDI-DI: 6973315739870BU
Reference: RM301-01
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 14:29

Manufacturer products Authorised representative products Authorised representative actors View details

Virus Sample Stabilizer

R513-02

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
UDI-DI: 06973315739795
Basic UDI-DI: 6973315739795C7
Reference: R513-01
EMDN: W0104010206
EMDN description: MEDIA IN TUBES (SOLID & LIQUID)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 14:29

Manufacturer products Authorised representative products Authorised representative actors View details