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897 device results listed.

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Bio·Firm

WI-MPXV-C42-25

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Wantaifu Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000037582
UDI-DI: D-WI-MPXV-C42-25L6
Basic UDI-DI: B-WI-MPXV-C42-25L6
Reference: WI-MPXV-C42-25
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 13:32

Manufacturer products Authorised representative products Authorised representative actors View details

Bio·Firm

WI-MICR-C86A-25

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Wantaifu Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000037582
UDI-DI: D-WI-MICR-C86A-25CQ
Basic UDI-DI: B-WI-MICR-C86A-25CQ
Reference: WI-MICR-C86A-25
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 13:32

Manufacturer products Authorised representative products Authorised representative actors View details

Bio·Firm

WI-MICR-C85A-25

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Wantaifu Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000037582
UDI-DI: D-WI-MICR-C85A-25CD
Basic UDI-DI: B-WI-MICR-C85A-25CD
Reference: WI-MICR-C85A-25
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 13:32

Manufacturer products Authorised representative products Authorised representative actors View details

Bio·Firm

WI-MICR-C83A-25

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Wantaifu Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000037582
UDI-DI: D-WI-MICR-C83A-25BP
Basic UDI-DI: B-WI-MICR-C83A-25BP
Reference: WI-MICR-C83A-25
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 13:32

Manufacturer products Authorised representative products Authorised representative actors View details

Bio·Firm

WI-MICR-C810C-25

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Wantaifu Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000037582
UDI-DI: D-WI-MICR-C810C-25U5
Basic UDI-DI: B-WI-MICR-C810C-25U5
Reference: WI-MICR-C810C-25
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 13:32

Manufacturer products Authorised representative products Authorised representative actors View details

Bio·Firm

WI-MICR-C810C-10

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Wantaifu Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000037582
UDI-DI: D-WI-MICR-C810C-10TQ
Basic UDI-DI: B-WI-MICR-C810C-10TQ
Reference: WI-MICR-C810C-10
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 13:32

Manufacturer products Authorised representative products Authorised representative actors View details

Bio·Firm

WI-MICR-C810C-01

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Wantaifu Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000037582
UDI-DI: D-WI-MICR-C810C-01TP
Basic UDI-DI: B-WI-MICR-C810C-01TP
Reference: WI-MICR-C810C-01
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 13:32

Manufacturer products Authorised representative products Authorised representative actors View details

Monkeypox Virus Nucleic Acid Detection Kit

VPK901

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VPK901KM
Basic UDI-DI: B-VPK901KM
Reference: VPK901-011
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:26

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2/M.pneumoniae IgG/IgM Combo Rapid Test

VISM-737

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VISM-737UT
Basic UDI-DI: B-VISM-737UT
Reference: VISM-737
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:24

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2/M.pneumoniae IgG Combo Rapid Test

VISM-727

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VISM-727UQ
Basic UDI-DI: B-VISM-727UQ
Reference: VISM-727
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:23

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2/Influenza A+B/RSV/Adenovirus Ag Combo Rapid Test

VISIRA-757

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VISIRA-757WS
Basic UDI-DI: B-VISIRA-757WS
Reference: VISIRA-757
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:23

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2/Influenza A+B/RSV Ag Combo Rapid Test

VISIR-737

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VISIR-737U4
Basic UDI-DI: B-VISIR-737U4
Reference: VISIR-737
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:23

Manufacturer products Authorised representative products Authorised representative actors View details

VivaDiag™ Monkeypox Virus Ag Rapid Test

VIMV-702

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VIMV-702UV
Basic UDI-DI: B-VIMV-702UV
Reference: VIMV-702
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:23

Manufacturer products Authorised representative products Authorised representative actors View details

VivaDiag Monkeypox Virus IgM/IgG Rapid Test

VIMV-426

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VIMV-426UU
Basic UDI-DI: B-VIMV-426UU
Reference: VIMV-426
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:23

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2/Flu A/FIu B Ag FIA Test VID47

VID47

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID4739
Basic UDI-DI: B-VID4739
Reference: VID47-08-011
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:22

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 Ag FIA Test VID44

VID44

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID4433
Basic UDI-DI: B-VID4433
Reference: VID44-08-011
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:22

Manufacturer products Authorised representative products Authorised representative actors View details

Monkeypox Virus Ag Test Kit (FIA)

VID208

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID208F2
Basic UDI-DI: B-VID208F2
Reference: VID208-01-011
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:22

Manufacturer products Authorised representative products Authorised representative actors View details

Monkeypox Virus IgG Test Kit (FIA)

VID206

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID206EW
Basic UDI-DI: B-VID206EW
Reference: VID206-01-011
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:22

Manufacturer products Authorised representative products Authorised representative actors View details

Monkeypox Virus IgM Test Kit (FIA)

VID205

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID205EU
Basic UDI-DI: B-VID205EU
Reference: VID205-01-011
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:22

Manufacturer products Authorised representative products Authorised representative actors View details

Monkeypox Virus IgM/IgG Test Kit (FIA)

VID114

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID114EQ
Basic UDI-DI: B-VID114EQ
Reference: VID114-01-011
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:20

Manufacturer products Authorised representative products Authorised representative actors View details