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22 device results listed.

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D-697994388Fa009WK8D

Monkeypox Virus Nucleic Acid Detection Kit (Fluorescence)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Kangsheng Information Technology (Hangzhou) Co. LTD
Manufacturer SRN: CN-MF-000053775
UDI-DI: D-697994388Fa009WK8D
Basic UDI-DI: B-697994388Fa009WK8D
Reference: Fa009
EMDN: W0105040532
EMDN description: MONKEYPOX VIRUS / MPOX - NA REAGENT
First on market country: Germany
Authorised representative: Crealkraft GmbH
Last updated: 17.07.2026 04:19

Manufacturer products Authorised representative products Authorised representative actors View details

D-697603130AMPV01EMWG

AMPV01，AMPV01D

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Danwei Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000041344
UDI-DI: D-697603130AMPV01EMWG
Basic UDI-DI: B-697603130AMPV01EMWG
Reference: AMPV01，AMPV01D
EMDN: W0105040532
EMDN description: MONKEYPOX VIRUS / MPOX - NA REAGENT
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:17

Manufacturer products Authorised representative products Authorised representative actors View details

D-69509960AMPV01UYBQ

AMPV01-AOG48E; AMPV01-AOG96E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-69509960AMPV01UYBQ
Basic UDI-DI: B-69509960AMPV01UYBQ
Reference: AMPV01-AOG48E; AMPV01-AOG96E
EMDN: W0105040532
EMDN description: MONKEYPOX VIRUS / MPOX - NA REAGENT
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 03:52

Manufacturer products Authorised representative products Authorised representative actors View details

Cowingene Monkeypox Virus Typing Detection Kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Taizhou Cowingene Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000042619
UDI-DI: D-ST08NC
Basic UDI-DI: B-ST08NC
Reference: ST08011X, ST08012X, ST08013W
EMDN: W0105040532
EMDN description: MONKEYPOX VIRUS / MPOX - NA REAGENT
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 15.07.2026 10:42

Manufacturer products Authorised representative products Authorised representative actors View details

Cowingene Monkeypox Virus Detection Kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Taizhou Cowingene Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000042619
UDI-DI: D-ST07NA
Basic UDI-DI: B-ST07NA
Reference: ST07011X, ST07012X, ST07013W
EMDN: W0105040532
EMDN description: MONKEYPOX VIRUS / MPOX - NA REAGENT
First on market country: Spain
Authorised representative: MedPath GmbH
Last updated: 15.07.2026 10:42

Manufacturer products Authorised representative products Authorised representative actors View details

D-81649002AMPV01HGSL

AMPV01-AHG48E; AMPV01-AHG96E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-81649002AMPV01HGSL
Basic UDI-DI: B-81649002AMPV01HGSL
Reference: AMPV01-AHG48E; AMPV01-AHG96E
EMDN: W0105040532
EMDN description: MONKEYPOX VIRUS / MPOX - NA REAGENT
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details

D-81649002AMPV01DK32Z

AMPV01D-AHG48E; AMPV01D-AHG96E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-81649002AMPV01DK32Z
Basic UDI-DI: B-81649002AMPV01DK32Z
Reference: AMPV01D-AHG48E; AMPV01D-AHG96E
EMDN: W0105040532
EMDN description: MONKEYPOX VIRUS / MPOX - NA REAGENT
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details

RevoDx Monkeypox qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387214254
Basic UDI-DI: B-08684387214254
Reference: IP202224-100
EMDN: W0105040532
EMDN description: MONKEYPOX VIRUS / MPOX - NA REAGENT
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 02:01

Manufacturer products View details

Monkeypox Virus Real Time PCR Kit

50 rxns/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Diagnostic Technology (Shandong) Co., Ltd.
Manufacturer SRN: CN-MF-000025964
UDI-DI: 06974969983039
Basic UDI-DI: B-06974969983039
Reference: 50 rxns/kit（DR1160-1）
EMDN: W0105040532
EMDN description: MONKEYPOX VIRUS / MPOX - NA REAGENT
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 21:17

Manufacturer products Authorised representative products Authorised representative actors View details

FlashDetect

FlashDetect™ LyocartE Monkeypox Virus Assay

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Coyote Bioscience Co., Ltd.
Manufacturer SRN: CN-MF-000024155
UDI-DI: 06974767391913
Basic UDI-DI: B-06974767391913
Reference: 6018022507-CE
EMDN: W0105040532
EMDN description: MONKEYPOX VIRUS / MPOX - NA REAGENT
First on market country: Sweden
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:41

Manufacturer products Authorised representative products Authorised representative actors View details

FlashDetect

FlashDetect™ LyocartE Monkeypox Virus Assay

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Coyote Bioscience Co., Ltd.
Manufacturer SRN: CN-MF-000024155
UDI-DI: 06974767391739
Basic UDI-DI: B-06974767391739
Reference: 6018022502-CE
EMDN: W0105040532
EMDN description: MONKEYPOX VIRUS / MPOX - NA REAGENT
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:41

Manufacturer products Authorised representative products Authorised representative actors View details

06974323012047

Real-time PCR Detection Kit for Monkeypox Virus

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06974323012047
Basic UDI-DI: B-06974323012047
Reference: D2361YH
EMDN: W0105040532
EMDN description: MONKEYPOX VIRUS / MPOX - NA REAGENT
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 18:49

Manufacturer products Authorised representative products Authorised representative actors View details

06974323012030

Real-time PCR Detection Kit for Monkeypox Virus

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06974323012030
Basic UDI-DI: B-06974323012030
Reference: D2361YH
EMDN: W0105040532
EMDN description: MONKEYPOX VIRUS / MPOX - NA REAGENT
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 18:49

Manufacturer products Authorised representative products Authorised representative actors View details

06970895479509

Monkeypox Virus Nucleic Acid Detection Kit (Fluorescent Probe-based Real-time PCR Assay)

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Jiangsu Mole Bioscience Co., LTD.
Manufacturer SRN: CN-MF-000001539
UDI-DI: 06970895479509
Basic UDI-DI: B-06970895479509
Reference: R60101T2050
EMDN: W0105040532
EMDN description: MONKEYPOX VIRUS / MPOX - NA REAGENT
First on market country: Finland
Authorised representative: Medunion S.L.
Last updated: 30.06.2026 10:00

Manufacturer products Authorised representative products Authorised representative actors View details

06970514080949

Monkeypox Virus Molecular Detection Kit (Real-time PCR)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Genobio Pharmaceutical Co., Ltd.
Manufacturer SRN: CN-MF-000027997
UDI-DI: 06970514080949
Basic UDI-DI: B-06970514080949
Reference: MXVPCR-50
EMDN: W0105040532
EMDN description: MONKEYPOX VIRUS / MPOX - NA REAGENT
First on market country: Germany
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 30.06.2026 04:07

Manufacturer products Authorised representative products Authorised representative actors View details

06970514080932

Monkeypox Virus Molecular Detection Kit (Real-time PCR)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Genobio Pharmaceutical Co., Ltd.
Manufacturer SRN: CN-MF-000027997
UDI-DI: 06970514080932
Basic UDI-DI: B-06970514080932
Reference: MXVPCR-25
EMDN: W0105040532
EMDN description: MONKEYPOX VIRUS / MPOX - NA REAGENT
First on market country: Germany
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 30.06.2026 04:07

Manufacturer products Authorised representative products Authorised representative actors View details

Singclean®

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Hangzhou Singclean Medical Products Co., Ltd.
Manufacturer SRN: CN-MF-000014098
UDI-DI: 06936020115414
Basic UDI-DI: B-06936020115414
Reference: IVD76-02-20t
EMDN: W0105040532
EMDN description: MONKEYPOX VIRUS / MPOX - NA REAGENT
First on market country: Germany
Authorised representative: SUNGO Europe B.V.
Last updated: 24.06.2026 15:09

Manufacturer products Authorised representative products Authorised representative actors View details

Singclean®

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Hangzhou Singclean Medical Products Co., Ltd.
Manufacturer SRN: CN-MF-000014098
UDI-DI: 06936020115407
Basic UDI-DI: B-06936020115407
Reference: IVD76-02-5t
EMDN: W0105040532
EMDN description: MONKEYPOX VIRUS / MPOX - NA REAGENT
First on market country: Germany
Authorised representative: SUNGO Europe B.V.
Last updated: 24.06.2026 15:09

Manufacturer products Authorised representative products Authorised representative actors View details

Singclean®

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Hangzhou Singclean Medical Products Co., Ltd.
Manufacturer SRN: CN-MF-000014098
UDI-DI: 06936020115391
Basic UDI-DI: B-06936020115391
Reference: MPV-02-01t
EMDN: W0105040532
EMDN description: MONKEYPOX VIRUS / MPOX - NA REAGENT
First on market country: Germany
Authorised representative: SUNGO Europe B.V.
Last updated: 24.06.2026 15:09

Manufacturer products Authorised representative products Authorised representative actors View details

Singclean®

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Hangzhou Singclean Medical Products Co., Ltd.
Manufacturer SRN: CN-MF-000014098
UDI-DI: 06936020115384
Basic UDI-DI: B-06936020115384
Reference: MPV-02-20t
EMDN: W0105040532
EMDN description: MONKEYPOX VIRUS / MPOX - NA REAGENT
First on market country: Germany
Authorised representative: SUNGO Europe B.V.
Last updated: 24.06.2026 15:09

Manufacturer products Authorised representative products Authorised representative actors View details