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191 device results listed.

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Human Papillomavirus (28 Types) Genotyping Detection Kit (Fluorescence PCR)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: D-0000128071400A3PD
Basic UDI-DI: B-0000128071400A3PD
Reference: HWTS-CC007
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 04.07.2026 08:58

Manufacturer products Authorised representative products Authorised representative actors View details

Freeze-dried Mycobacterium Tuberculosis Nucleic Acid and Rifampicin, Isoniazid Resistance Detection Kit (Melting Curve)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: D-0000128071390DAS4
Basic UDI-DI: B-0000128071390DAS4
Reference: HWTS-RT105
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 04.07.2026 08:58

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue NS1 Antigen, IgM/IgG Antibody Dual Detection Kit (Immunochromatography)

1 test/kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: D-000012807086165QZ
Basic UDI-DI: B-000012807086165QZ
Reference: HWTS-FE031A
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 04.07.2026 08:58

Manufacturer products Authorised representative products Authorised representative actors View details

Freeze-dried Mycobacterium Tuberculosis DNA Detection Kit (Fluorescence PCR)

48 tests/kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: D-000012807042309NR
Basic UDI-DI: B-000012807042309NR
Reference: HWTS-RT105C
EMDN: W0105010799
EMDN description: MYCOBACTERIA REAGENTS - OTHER
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 04.07.2026 08:58

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue NS1 Antigen, IgM/IgG Antibody Dual Detection Kit (Immunochromatography)

20 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: D-000012807086266R8
Basic UDI-DI: B-000012807086266R8
Reference: HWTS-FE031B
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 04.07.2026 08:58

Manufacturer products Authorised representative products Authorised representative actors View details

Freeze-dried Mycobacterium Tuberculosis DNA Detection Kit (Fluorescence PCR)

50 tests/kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: D-000012807042208NJ
Basic UDI-DI: B-000012807042208NJ
Reference: HWTS-RT105A
EMDN: W0105010799
EMDN description: MYCOBACTERIA REAGENTS - OTHER
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 04.07.2026 08:57

Manufacturer products Authorised representative products Authorised representative actors View details

Freeze-dried Mycobacterium Tuberculosis DNA Detection Kit (Fluorescence PCR)

20 tests/kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: D-00001280704210BNX
Basic UDI-DI: B-00001280704210BNX
Reference: HWTS-RT105B
EMDN: W0105010799
EMDN description: MYCOBACTERIA REAGENTS - OTHER
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 04.07.2026 08:57

Manufacturer products Authorised representative products Authorised representative actors View details

Carbapenem Resistance Gene Detection Kit (Fluorescence PCR)

HWTS-OT149A

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: 06974849369649
Basic UDI-DI: 697484936HWTS-OT149A5A
Reference: HWTS-OT149A
EMDN: W0104080606
EMDN description: NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED CARBAPENEMASE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 17:37

Manufacturer products Authorised representative products Authorised representative actors View details

Freeze-dried Influenza A Virus/Influenza B Virus Nucleic Acid Detection Kit (Fluorescence PCR)

HWTS-RT176A

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: 06974849369595
Basic UDI-DI: 697484936W01050405V2
Reference: HWTS-RT176A
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 17:36

Manufacturer products Authorised representative products Authorised representative actors View details

Freeze-dried Six Respiratory Pathogens Nucleic Acid Detection Kit (Fluorescence PCR)

HWTS-RT177A

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: 06974849368680
Basic UDI-DI: 697484936RT177AVK
Reference: HWTS-RT177A
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 17:36

Manufacturer products Authorised representative products Authorised representative actors View details

Sputasol

4×100mL/kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: 06974849366785
Basic UDI-DI: 697484936W0599NY
Reference: HWTS-3012C
EMDN: W0599
EMDN description: IVD GENERAL USE CONSUMABLE DEVICES - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 17:36

Manufacturer products Authorised representative products Authorised representative actors View details

Macro & Micro-Test Fluorescence Reader

HWTS IF 100

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: 06974849366716
Basic UDI-DI: 697484936W0201020201DG
Reference: HWTS-EQ005
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 17:36

Manufacturer products Authorised representative products Authorised representative actors View details

Macro & Micro-Test Automatic Nucleic Acid Extractor

HWTS-NPure32

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: 06974849366570
Basic UDI-DI: 697484936W02069099YC
Reference: HWTS-3006
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 17:36

Manufacturer products Authorised representative products Authorised representative actors View details

Macro & Micro-Test Viral DNA/RNA Kit

Type Ⅰ: 50 tests/ kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: 06974849366525
Basic UDI-DI: 697484936W0105900101HP
Reference: HWTS-3017-50
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 17:36

Manufacturer products Authorised representative products Authorised representative actors View details

Easy Amp Real-time Fluorescence Isothermal Detection System

HWTS 1600P,HWTS 1600S

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: 06974849366389
Basic UDI-DI: 697484936W02050199W7
Reference: HWTS-EQ002
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 17:36

Manufacturer products Authorised representative products Authorised representative actors View details

Macro & Micro-Test Sample Collecting, Mailing & Shipping Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingSingle use

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: 06974849366228
Basic UDI-DI: 697484936W05019099Y8
Reference: HWTS-3008-1
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 17:36

Manufacturer products Authorised representative products Authorised representative actors View details

Nucleic Acid Detection Kit for Clostridium Difficile toxin A/B gene (Fluorescence PCR)

HWTS-EV032A

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: 06974849366198
Basic UDI-DI: 697484936HWTS-EV032AYS
Reference: HWTS-EV032A
EMDN: W0105011802
EMDN description: C.DIFFICILE TOXIN A/B DETECTION
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 17:36

Manufacturer products Authorised representative products Authorised representative actors View details

Freeze-dried Six Respiratory Pathogens Nucleic Acid Detection Kit (Fluorescence PCR)

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: 06974849368697
Basic UDI-DI: 697484936RT177AVK
Reference: HWTS-RT177B
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.06.2026 06:48

Manufacturer products Authorised representative products Authorised representative actors View details

Freeze-dried Six Respiratory Pathogens Nucleic Acid Detection Kit (Fluorescence PCR)

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: 06974849368703
Basic UDI-DI: 697484936RT177AVK
Reference: HWTS-RT177C
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.06.2026 06:48

Manufacturer products Authorised representative products Authorised representative actors View details

Freeze-dried Six Respiratory Pathogens Nucleic Acid Detection Kit (Fluorescence PCR)

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: 06974849368727
Basic UDI-DI: 697484936RT177AVK
Reference: HWTS-RT177E
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.06.2026 06:48

Manufacturer products Authorised representative products Authorised representative actors View details