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56 device results listed.

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Monkeypox Virus Antibody Test Cassette

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-acrMXB402F8V
Basic UDI-DI: B-acrMXB402F8V
Reference: acrMXB402F
EMDN: W0105099008
EMDN description: MONKEYPOX VIRUS / MPOX RT & POC
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 12.08.2026 23:14

Manufacturer products Authorised representative products Authorised representative actors View details

Monkeypox Virus Antigen Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-IMXG-ACO402FM
Basic UDI-DI: B-IMXG-ACO402FM
Reference: IMXG-ACO402
EMDN: W0105099008
EMDN description: MONKEYPOX VIRUS / MPOX RT & POC
First on market country: Finland
Authorised representative: VidaQuick Biotech S.L.
Last updated: 07.08.2026 02:19

Manufacturer products Authorised representative products Authorised representative actors View details

Monkeypox Virus Antibody Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-IMXB-ACO402CN
Basic UDI-DI: B-IMXB-ACO402CN
Reference: IMXB-ACO402
EMDN: W0105099008
EMDN description: MONKEYPOX VIRUS / MPOX RT & POC
First on market country: Latvia
Authorised representative: VidaQuick Biotech S.L.
Last updated: 07.08.2026 02:19

Manufacturer products Authorised representative products Authorised representative actors View details

Monkeypox Virus Antigen Rapid Test

IMPX0002

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-IMPX00054
Basic UDI-DI: B-IMPX00054
Reference: IMPX0002
EMDN: W0105099008
EMDN description: MONKEYPOX VIRUS / MPOX RT & POC
First on market country: Germany
Authorised representative: HUMISS TRADING S. L.
Last updated: 06.08.2026 01:36

Manufacturer products Authorised representative products Authorised representative actors View details

Monkeypox Virus IgM/IgG Ab Test

Strip & Cassette

IVD generalIVDDOn the marketKitProfessional testingReagentSelf testingSingle use

Manufacturer: Abiores Technology (Beijing) Co.,Ltd.
Manufacturer SRN: CN-MF-000022952
UDI-DI: 06958982140419
Basic UDI-DI: B-06958982140419
Reference: AB330-20
EMDN: W0105099008
EMDN description: MONKEYPOX VIRUS / MPOX RT & POC
First on market country: Croatia
Authorised representative: Medunion S.L.
Last updated: 05.08.2026 14:40

Manufacturer products Authorised representative products Authorised representative actors View details

Monkeypox Virus Ag Test

Strip & Cassette

IVD generalIVDDOn the marketKitProfessional testingReagentSelf testingSingle useSterile

Manufacturer: Abiores Technology (Beijing) Co.,Ltd.
Manufacturer SRN: CN-MF-000022952
UDI-DI: 06958982140402
Basic UDI-DI: B-06958982140402
Reference: AB331-20
EMDN: W0105099008
EMDN description: MONKEYPOX VIRUS / MPOX RT & POC
First on market country: Croatia
Authorised representative: Medunion S.L.
Last updated: 05.08.2026 14:40

Manufacturer products Authorised representative products Authorised representative actors View details

Monkeypox Virus Antigen Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-ACO-MXG-402VD
Basic UDI-DI: B-ACO-MXG-402VD
Reference: ACO-MXG-402
EMDN: W0105099008
EMDN description: MONKEYPOX VIRUS / MPOX RT & POC
First on market country: Austria
Authorised representative: VidaQuick Biotech S.L.
Last updated: 04.08.2026 19:29

Manufacturer products Authorised representative products Authorised representative actors View details

Monkeypox Antigen Rapid Test

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Zhejiang Anji Saianfu Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045029
UDI-DI: 69743840309812
Basic UDI-DI: B-69743840309812
Reference: 3027101
EMDN: W0105099008
EMDN description: MONKEYPOX VIRUS / MPOX RT & POC
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 17.07.2026 04:11

Manufacturer products Authorised representative products Authorised representative actors View details

Monkeypox Antibody Rapid Test (Whole blood/Serum/Plasma)

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Zhejiang Anji Saianfu Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045029
UDI-DI: 69743840309508
Basic UDI-DI: B-69743840309508
Reference: 3027102
EMDN: W0105099008
EMDN description: MONKEYPOX VIRUS / MPOX RT & POC
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 17.07.2026 04:11

Manufacturer products Authorised representative products Authorised representative actors View details

Monkeypox Virus Antigen Rapid Test(Swab)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646MON005N54C
Basic UDI-DI: B-697424646MON005N54C
Reference: MON Ag-6012
EMDN: W0105099008
EMDN description: MONKEYPOX VIRUS / MPOX RT & POC
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:09

Manufacturer products Authorised representative products Authorised representative actors View details

Monkeypox Virus Antigen Rapid Test(Serum/Plasma)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646MON004N343
Basic UDI-DI: B-697424646MON004N343
Reference: MON Ag-3012
EMDN: W0105099008
EMDN description: MONKEYPOX VIRUS / MPOX RT & POC
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:09

Manufacturer products Authorised representative products Authorised representative actors View details

Monkeypox Virus Antigen Rapid Test(Whole blood/Serum/Plasma)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646MON003MZ67
Basic UDI-DI: B-697424646MON003MZ67
Reference: MON Ag-4012
EMDN: W0105099008
EMDN description: MONKEYPOX VIRUS / MPOX RT & POC
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:09

Manufacturer products Authorised representative products Authorised representative actors View details

Monkeypox Virus IgG/IgM Rapid Test(Serum/Plasma)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646MON002MX5W
Basic UDI-DI: B-697424646MON002MX5W
Reference: MON Ab-3022
EMDN: W0105099008
EMDN description: MONKEYPOX VIRUS / MPOX RT & POC
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:09

Manufacturer products Authorised representative products Authorised representative actors View details

Monkeypox Virus IgG/IgM Rapid Test(Whole blood/Serum/Plasma)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646MON001MV5M
Basic UDI-DI: B-697424646MON001MV5M
Reference: MON Ab-4022
EMDN: W0105099008
EMDN description: MONKEYPOX VIRUS / MPOX RT & POC
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:09

Manufacturer products Authorised representative products Authorised representative actors View details

Monkeypox Virus Antigen Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646MON000MT5C
Basic UDI-DI: B-697424646MON000MT5C
Reference: MON Ag-4012/MON Ag-3012/MON Ag-6012
EMDN: W0105099008
EMDN description: MONKEYPOX VIRUS / MPOX RT & POC
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 17.07.2026 04:09

Manufacturer products Authorised representative products Authorised representative actors View details

Acmex

Cassette

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Acmex Bio-Technology (Chongqing) Co., Ltd.
Manufacturer SRN: CN-MF-000037745
UDI-DI: 06976232252163
Basic UDI-DI: B-06976232252163
Reference: CA03-70-422P25
EMDN: W0105099008
EMDN description: MONKEYPOX VIRUS / MPOX RT & POC
First on market country: Türkiye
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 19:32

Manufacturer products Authorised representative products Authorised representative actors View details

Monkeypox Virus Antigen Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IMXG-R402HE
Basic UDI-DI: B-IMXG-R402HE
Reference: IMXG-R402
EMDN: W0105099008
EMDN description: MONKEYPOX VIRUS / MPOX RT & POC
First on market country: Austria
Authorised representative: VidaQuick Biotech S.L.
Last updated: 14.07.2026 01:39

Manufacturer products Authorised representative products Authorised representative actors View details

Monkeypox Virus Antibody Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IMXB-R402FD
Basic UDI-DI: B-IMXB-R402FD
Reference: IMXB-R402
EMDN: W0105099008
EMDN description: MONKEYPOX VIRUS / MPOX RT & POC
First on market country: Austria
Authorised representative: VidaQuick Biotech S.L.
Last updated: 14.07.2026 01:39

Manufacturer products Authorised representative products Authorised representative actors View details

Mpox Virus IgG/IgM Ab Rapid Test Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: D-GKPD124XC
Basic UDI-DI: B-GKPD124XC
Reference: GKPD124
EMDN: W0105099008
EMDN description: MONKEYPOX VIRUS / MPOX RT & POC
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 14.07.2026 00:37

Manufacturer products Authorised representative products Authorised representative actors View details

Mpox Virus Ag Rapid Test Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: D-GKPD123XA
Basic UDI-DI: B-GKPD123XA
Reference: GKPD123
EMDN: W0105099008
EMDN description: MONKEYPOX VIRUS / MPOX RT & POC
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 14.07.2026 00:37

Manufacturer products Authorised representative products Authorised representative actors View details