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165 device results listed.

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Rapid identification Kit for B.1.1.7/B.1.351 and P.1 of SARS-CoV-2 (ARMS-PCR)

50 tests/kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: 06974849366167
Basic UDI-DI: B-06974849366167
Reference: HWTS-RT078A
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 20:51

Manufacturer products Authorised representative products Authorised representative actors View details

Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for Novel Coronavirus (SARS-CoV-2)

16 tests/kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: 06974849366150
Basic UDI-DI: B-06974849366150
Reference: HWTS-RT056A
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 20:51

Manufacturer products Authorised representative products Authorised representative actors View details

Real time fluorescent RT-PCR kit for detecting six kinds of respiratory pathogens

50tests/kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: 06974849366068
Basic UDI-DI: B-06974849366068
Reference: HWTS-RT058A
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 20:50

Manufacturer products Authorised representative products Authorised representative actors View details

Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for Influenza A virus

Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for Influenza A virus

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: 06974849366020
Basic UDI-DI: B-06974849366020
Reference: HWTS-RT049A
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 20:50

Manufacturer products Authorised representative products Authorised representative actors View details

Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for Dengue virus

Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for Dengue virus

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: 06974849366013
Basic UDI-DI: B-06974849366013
Reference: HWTS-FE024A
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 20:50

Manufacturer products Authorised representative products Authorised representative actors View details

Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for Enterovirus

Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for Enterovirus

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: 06974849366006
Basic UDI-DI: B-06974849366006
Reference: HWTS-EV015A
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 20:50

Manufacturer products Authorised representative products Authorised representative actors View details

PML/RARA Gene Fusion Probe Detection Kit (fluorescence in situ hybridization )

IVD generalIVDDOn the marketAnimal tissuesReagentSingle use

Manufacturer: Wuhan YZY Medical Science and Technology Co., Ltd
Manufacturer SRN: CN-MF-000036323
UDI-DI: 06974604726199
Basic UDI-DI: B-06974604726199
Reference: IVDD
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 20:02

Manufacturer products Authorised representative products Authorised representative actors View details

ATM/p53/13q14/RB1/CSP12 gene Probe Detection Kit (fluorescence in situ hybridization )

IVD generalIVDDOn the marketAnimal tissuesReagentSingle use

Manufacturer: Wuhan YZY Medical Science and Technology Co., Ltd
Manufacturer SRN: CN-MF-000036323
UDI-DI: 06974604726182
Basic UDI-DI: B-06974604726182
Reference: IVDD
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 20:02

Manufacturer products Authorised representative products Authorised representative actors View details

i(17q) gene Probe Detection Kit (fluorescence in situ hybridization )

IVD generalIVDDOn the marketAnimal tissuesReagentSingle use

Manufacturer: Wuhan YZY Medical Science and Technology Co., Ltd
Manufacturer SRN: CN-MF-000036323
UDI-DI: 06974604726007
Basic UDI-DI: B-06974604726007
Reference: IVDD
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 20:01

Manufacturer products Authorised representative products Authorised representative actors View details

HER-2 DNA Probe Kit (fluorescence in situ hybridization )

IVD generalIVDDOn the marketAnimal tissuesReagentSingle use

Manufacturer: Wuhan YZY Medical Science and Technology Co., Ltd
Manufacturer SRN: CN-MF-000036323
UDI-DI: 06974604723099
Basic UDI-DI: B-06974604723099
Reference: IVDD
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 20:01

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Kit for Novel-Coronavirus (2019-nCoV) RNA (Isothermal Amplification-Real Time Fluorescence Assay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Ustar Biotechnologies (Hangzhou) Ltd.
Manufacturer SRN: CN-MF-000014615
UDI-DI: 06973492240299
Basic UDI-DI: B-06973492240299
Reference: U20223
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 17:19

Manufacturer products Authorised representative products Authorised representative actors View details

Monkeypox Virus Real Time PCR Kit

YJC70115NW-50T

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Jiangsu Bioperfectus Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000014691
UDI-DI: 06973342003456
Basic UDI-DI: B-06973342003456
Reference: YJC70115NW-50T
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 17:08

Manufacturer products Authorised representative products Authorised representative actors View details

Monkeypox Virus Real Time PCR Kit

YJC70115NW-25T

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Jiangsu Bioperfectus Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000014691
UDI-DI: 06973342003449
Basic UDI-DI: B-06973342003449
Reference: YJC70115NW-25T
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 17:08

Manufacturer products Authorised representative products Authorised representative actors View details

Detection Kit for Monkeypox Virus DNA (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle useSterile

Manufacturer: QINGDAO HUAREN MEDICAL PRODUCT CO.,LTD.
Manufacturer SRN: CN-MF-000028417
UDI-DI: 06971760720054
Basic UDI-DI: B-06971760720054
Reference: 50 tests/kit
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 13:46

Manufacturer products Authorised representative products Authorised representative actors View details

Detection Kit for Monkeypox Virus DNA (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle useSterile

Manufacturer: QINGDAO HUAREN MEDICAL PRODUCT CO.,LTD.
Manufacturer SRN: CN-MF-000028417
UDI-DI: 06971760720047
Basic UDI-DI: B-06971760720047
Reference: 25 tests/kit
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 13:46

Manufacturer products Authorised representative products Authorised representative actors View details

Detection Kit for Monkeypox Virus DNA (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle useSterile

Manufacturer: QINGDAO HUAREN MEDICAL PRODUCT CO.,LTD.
Manufacturer SRN: CN-MF-000028417
UDI-DI: 06971760720030
Basic UDI-DI: B-06971760720030
Reference: 20 tests/kit
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 13:46

Manufacturer products Authorised representative products Authorised representative actors View details

Detection Kit for Monkeypox Virus DNA (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle useSterile

Manufacturer: QINGDAO HUAREN MEDICAL PRODUCT CO.,LTD.
Manufacturer SRN: CN-MF-000028417
UDI-DI: 06971760720023
Basic UDI-DI: B-06971760720023
Reference: 10 tests/kit
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 13:46

Manufacturer products Authorised representative products Authorised representative actors View details

Detection Kit for Monkeypox Virus DNA (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle useSterile

Manufacturer: QINGDAO HUAREN MEDICAL PRODUCT CO.,LTD.
Manufacturer SRN: CN-MF-000028417
UDI-DI: 06971760720016
Basic UDI-DI: B-06971760720016
Reference: 5 tests/kit
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 13:46

Manufacturer products Authorised representative products Authorised representative actors View details

D-00105900102032ZV

20 Tests/Kit

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Beijing Healthgene Laboratory Co.,Ltd
Manufacturer SRN: CN-MF-000032465
UDI-DI: D-00105900102032ZV
Basic UDI-DI: B-00105900102032ZV
Reference: 20 Tests/Kit
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 04.07.2026 09:10

Manufacturer products Authorised representative products Authorised representative actors View details

Demi DNA Reagent Cassette

Nucleic acid amplification mastermix reagent IVD

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

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044003073
Basic UDI-DI: 93430440W010590010259
Reference: 40241
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
First on market country: Italy
Authorised representative: R-Biopharm AG
Last updated: 04.07.2026 00:05

Manufacturer products Authorised representative products Authorised representative actors View details