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228 device results listed.

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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

Real-Time Quantitative Thermal Cycler

FMR3

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
UDI-DI: 06973315739740
Basic UDI-DI: 6973315739740BE
Reference: FMR3
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: Caretechion GmbH
Last updated: 02.07.2026 14:29

Manufacturer products Authorised representative products Authorised representative actors View details

Full-automatic Nucleic Acids Extraction Instrument

VNP-96

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
UDI-DI: 06973315739726
Basic UDI-DI: 6973315739726BL
Reference: VNP-96
EMDN: W02060101
EMDN description: AUTOMATED SYSTEMS FOR THE MANAGEMENT OF PRE AND POST-ANALYSIS
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

Automatic Nucleic Acids Extraction Instrument

VNP-32YL

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
UDI-DI: 06973315739597
Basic UDI-DI: 6973315739597BZ
Reference: VNP-32YL
EMDN: W02060101
EMDN description: AUTOMATED SYSTEMS FOR THE MANAGEMENT OF PRE AND POST-ANALYSIS
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

Automatic Fluorescence Immunoassay Analyzer

QD-S2000

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
UDI-DI: 06973315739580
Basic UDI-DI: 6973315739580BG
Reference: QD-S2000
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
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

Quantum Dot Fluorescence Immune Analyzer

QD-S600

IVD Class AIVDR 2017/746On the marketDirect markingInstrument

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
UDI-DI: 06973315739566
Basic UDI-DI: 6973315739566BN
Reference: QD-S600
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
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

Cell-Free DNA Collection Tube

BH106ME-C1-XY、BH106ME-C1

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
UDI-DI: 06973315739498
Basic UDI-DI: 6973315739498BW
Reference: BH106ME-C1-XY
EMDN: W050101010201
EMDN description: BLOOD COLLECTION, TUBES WITH ADDITIVES OR SERUM SEPARATOR
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 02.07.2026 14:29

Manufacturer products Authorised representative products Authorised representative actors View details

HPV Sample Preservation Solution

PHPV01C-01

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

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
UDI-DI: 06973315739405
Basic UDI-DI: 6973315739405AV
Reference: PHPV01C-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: 02.07.2026 14:29

Manufacturer products Authorised representative products Authorised representative actors View details

Universal DNA/RNA Extraction Kit

ECM01ME-01

IVD Class AIVDR 2017/746On the marketKitProfessional testingSingle use

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
UDI-DI: 06973315739399
Basic UDI-DI: 6973315739399BT
Reference: ECM01ME-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

Vazyme Target Capture Hybridization and Wash Pro Kit

NC401ME-C1, NC401ME-C1-P1

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
UDI-DI: 06973315739351
Basic UDI-DI: 6973315739351AX
Reference: NC401ME-C1
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 02.07.2026 14:29

Manufacturer products Authorised representative products Authorised representative actors View details

Vazyme Target Capture Hybridization and Wash Kit

NC403ME-C1

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
UDI-DI: 06973315739344
Basic UDI-DI: 6973315739344B2
Reference: NC403ME-C1
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 02.07.2026 14:29

Manufacturer products Authorised representative products Authorised representative actors View details

Vazyme MedExome Dx Panel

NC004ME-C1

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
UDI-DI: 06973315739337
Basic UDI-DI: 6973315739337B5
Reference: NC004ME-C1
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 02.07.2026 14:29

Manufacturer products Authorised representative products Authorised representative actors View details

Vazyme Comprehensive Exome Dx Panel

NC001ME-01

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
UDI-DI: 06973315739290
Basic UDI-DI: 6973315739290B4
Reference: NC001ME-01
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 02.07.2026 14:29

Manufacturer products Authorised representative products Authorised representative actors View details

VAHTS DNA Library Prep Kit for MGI

IVD Class AIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
UDI-DI: 06973315738996
Basic UDI-DI: 6973315738996CC
Reference: NDM609ME-02
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
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

Automated Liquid Handling Workstation

VNL-96

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
UDI-DI: 06973315738767
Basic UDI-DI: 6973315738675BM
Reference: VNL-96
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
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