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242 device results listed.

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Equalbit 1 × dsDNA HS Assay Kit

EQ121ME

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
UDI-DI: 06973315736008
Basic UDI-DI: 69733157360089S
Reference: EQ121ME-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

Logilet Logicore System

Logicore-a

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
UDI-DI: 06973315734936
Basic UDI-DI: 6973315734769B3
Reference: Logicore-a
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
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

Logilet Respiratory Pathogen Panel

VD1011

IVD Class BIVDR 2017/746On the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
UDI-DI: 06973315734882
Basic UDI-DI: 6973315734882AY
Reference: VD1011
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Hungary
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

06973315734875

Quality Control Kit for Logilet Respiratory Pathogen Panel

IVD Class BIVDR 2017/746On the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
UDI-DI: 06973315734875
Basic UDI-DI: 6973315734875B3
Reference: QC1011
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
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

Sample Preservation Buffer

IVD Class AIVDR 2017/746On the marketDirect markingKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
UDI-DI: 06973315734820
Basic UDI-DI: 6973315734820AA
Reference: VP1013-01
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

Fluorescence Immune Analyzer

QD-S900

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
UDI-DI: 06973315734707
Basic UDI-DI: 6973315738668BQ
Reference: QD-S900
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

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
UDI-DI: 06973315739504
Basic UDI-DI: 6973315739498BW
Reference: BH106ME-C1
EMDN: W050101010201
EMDN description: BLOOD COLLECTION, TUBES WITH ADDITIVES OR SERUM SEPARATOR
First on market country: -
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 23.06.2026 22:40

Manufacturer products Authorised representative products Authorised representative actors View details

Sample Preservation Buffer

IVD Class AIVDR 2017/746On the marketDirect markingKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
UDI-DI: 06973315734837
Basic UDI-DI: 6973315734820AA
Reference: VP1013-02
EMDN: W0104010204
EMDN description: SAMPLE TRANSPORT FOR NA TESTING
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.06.2026 13:22

Manufacturer products Authorised representative products Authorised representative actors View details

Sample Preservation Buffer

IVD Class AIVDR 2017/746On the marketDirect markingKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
UDI-DI: 06973315734844
Basic UDI-DI: 6973315734820AA
Reference: VP1013-03
EMDN: W0104010204
EMDN description: SAMPLE TRANSPORT FOR NA TESTING
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.06.2026 13:22

Manufacturer products Authorised representative products Authorised representative actors View details

Equalbit 1 × dsDNA HS Assay Kit

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
UDI-DI: 06973315736336
Basic UDI-DI: 69733157360089S
Reference: EQ121ME-01
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.06.2026 13:22

Manufacturer products Authorised representative products Authorised representative actors View details

VAHTS DNA Library Prep Kit for Illumina

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

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
UDI-DI: 06973315736350
Basic UDI-DI: 6973315736343AB
Reference: ND609ME-01
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.06.2026 13:22

Manufacturer products Authorised representative products Authorised representative actors View details

VAMNE MagUltra Circulating Cell-free DNA Isolation Mini 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: 06973315738958
Basic UDI-DI: 6973315736367AR
Reference: N904-C2ME
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.06.2026 13:22

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: 06973315739009
Basic UDI-DI: 6973315738996CC
Reference: NDM609ME-01
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.06.2026 13:22

Manufacturer products Authorised representative products Authorised representative actors View details

Vazyme Target Capture Hybridization and Wash Pro Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
UDI-DI: 06973315739368
Basic UDI-DI: 6973315739351AX
Reference: NC401ME-C1-P1
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: -
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 16.06.2026 13:22

Manufacturer products Authorised representative products Authorised representative actors View details

HPV Sample Preservation Solution

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: 06973315739412
Basic UDI-DI: 6973315739405AV
Reference: PHPV01C-02
EMDN: W0104010204
EMDN description: SAMPLE TRANSPORT FOR NA TESTING
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.06.2026 13:22

Manufacturer products Authorised representative products Authorised representative actors View details

HPV Sample Preservation Solution

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: 06973315739429
Basic UDI-DI: 6973315739405AV
Reference: PHPV01C-03
EMDN: W0104010204
EMDN description: SAMPLE TRANSPORT FOR NA TESTING
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.06.2026 13:22

Manufacturer products Authorised representative products Authorised representative actors View details

Virus Sample Stabilizer

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

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
UDI-DI: 06973315739801
Basic UDI-DI: 6973315739795C7
Reference: R513-02
EMDN: W0104010206
EMDN description: MEDIA IN TUBES (SOLID & LIQUID)
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.06.2026 13:22

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: 06973315739887
Basic UDI-DI: 6973315739870BU
Reference: RM301-02
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.06.2026 13:22

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: 06973315739917
Basic UDI-DI: 6973315739870BU
Reference: RM302-01
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.06.2026 13:22

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: 06973315739924
Basic UDI-DI: 6973315739870BU
Reference: RM302-02
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.06.2026 13:22

Manufacturer products Authorised representative products Authorised representative actors View details