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Nipah 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-GKPD113X7
Basic UDI-DI: B-GKPD113X7
Reference: GKPD113
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
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

Nipah 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-GKPD112X5
Basic UDI-DI: B-GKPD112X5
Reference: GKPD112
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
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

Respiratory Syncytial Virus (RSV) 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-GKPD102X2
Basic UDI-DI: B-GKPD102X2
Reference: GKPD102
EMDN: W0105099002
EMDN description: RSV - RT & POC
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 14.07.2026 00:36

Manufacturer products Authorised representative products Authorised representative actors View details

Mumps Virus 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-GKPD101WY
Basic UDI-DI: B-GKPD101WY
Reference: GKPD101
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 14.07.2026 00:36

Manufacturer products Authorised representative products Authorised representative actors View details

Adenovirus 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-GKPD100WW
Basic UDI-DI: B-GKPD100WW
Reference: GKPD100
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 14.07.2026 00:36

Manufacturer products Authorised representative products Authorised representative actors View details

RSV Antigen Rapid Test Cassette (Swab)

GCRSV-502a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCRSV-502aHGLX
Basic UDI-DI: B-GCRSV-502aHGLX
Reference: GCRSV-502a
EMDN: W0105099002
EMDN description: RSV - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:30

Manufacturer products Authorised representative products Authorised representative actors View details

RSV Antigen Rapid Test Cassette (Swab)

GCRSV-502Ca

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCRSV-502CaHGVH
Basic UDI-DI: B-GCRSV-502CaHGVH
Reference: GCRSV-502Ca
EMDN: W0105099002
EMDN description: RSV - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:30

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19/Flu A&B/RSV/Adeno/HPIV/HMPV/RhV/M. pneumoniae Ag Combo Rapid Test Cassette (Swab)

GCRESA-T555a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCRESA-T555aNB
Basic UDI-DI: B-GCRESA-T555aNB
Reference: GCRESA-T555a
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:29

Manufacturer products Authorised representative products Authorised representative actors View details

Mononucleosis IgG/IgM Rapid Test Cassette (Whole blood/Serum/Plasma)

GCMON-425a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCMON-425aHG9Q
Basic UDI-DI: B-GCMON-425aHG9Q
Reference: GCMON-425a
EMDN: W0105099003
EMDN description: MONONUCLEOSIS (EBV) - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:29

Manufacturer products Authorised representative products Authorised representative actors View details

Mononucleosis IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)

GCMON-425a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCMON-425a7C
Basic UDI-DI: B-GCMON-425a7C
Reference: GCMON-425a
EMDN: W0105099003
EMDN description: MONONUCLEOSIS (EBV) - RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:29

Manufacturer products Authorised representative products Authorised representative actors View details

Mononucleosis Rapid Test Cassette (Whole Blood/Serum/Plasma)

GCMON-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCMON-402aHG8D
Basic UDI-DI: B-GCMON-402aHG8D
Reference: GCMON-402a
EMDN: W0105099003
EMDN description: MONONUCLEOSIS (EBV) - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:29

Manufacturer products Authorised representative products Authorised representative actors View details

Mononucleosis Rapid Test Cassette (Whole Blood/Serum/Plasma)

GCMON-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCMON-402a6R
Basic UDI-DI: B-GCMON-402a6R
Reference: GCMON-402a
EMDN: W0105099003
EMDN description: MONONUCLEOSIS (EBV) - RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:29

Manufacturer products Authorised representative products Authorised representative actors View details

Mononucleosis IgG/lgM Rapid Test Cassette(Serum/Plasma)

GCMON-325a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCMON-325aHG9B
Basic UDI-DI: B-GCMON-325aHG9B
Reference: GCMON-325a
EMDN: W0105099003
EMDN description: MONONUCLEOSIS (EBV) - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:29

Manufacturer products Authorised representative products Authorised representative actors View details

Mononucleosis IgG/IgM Rapid Test Cassette (Serum/Plasma)

GCMON-325a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCMON-325a75
Basic UDI-DI: B-GCMON-325a75
Reference: GCMON-325a
EMDN: W0105099003
EMDN description: MONONUCLEOSIS (EBV) - RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:29

Manufacturer products Authorised representative products Authorised representative actors View details

Monkeypox Ag Rapid Test Cassette (Swab)

GCMKP-502b

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCMKP-502bHG79
Basic UDI-DI: B-GCMKP-502bHG79
Reference: GCMKP-502b
EMDN: W0105099008
EMDN description: MONKEYPOX VIRUS / MPOX RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:29

Manufacturer products Authorised representative products Authorised representative actors View details

Monkeypox Ag Rapid Test Cassette (Swab)

GCMKP-502b

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCMKP-502b5Q
Basic UDI-DI: B-GCMKP-502b5Q
Reference: GCMKP-502b
EMDN: W0105099008
EMDN description: MONKEYPOX VIRUS / MPOX RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:29

Manufacturer products Authorised representative products Authorised representative actors View details

Monkeypox IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)

GCMKP-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCMKP-402aHG6P
Basic UDI-DI: B-GCMKP-402aHG6P
Reference: GCMKP-402a
EMDN: W0105099008
EMDN description: MONKEYPOX VIRUS / MPOX RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:29

Manufacturer products Authorised representative products Authorised representative actors View details

Monkeypox IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)

GCMKP-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCMKP-402a5F
Basic UDI-DI: B-GCMKP-402a5F
Reference: GCMKP-402a
EMDN: W0105099008
EMDN description: MONKEYPOX VIRUS / MPOX RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:29

Manufacturer products Authorised representative products Authorised representative actors View details

Flu A/RSV Ag Combo Rapid Test Cassette (Swab)

GCFR(A)-T502a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCFR(A)-T502aMC
Basic UDI-DI: B-GCFR(A)-T502aMC
Reference: GCFR(A)-T502a
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:27

Manufacturer products Authorised representative products Authorised representative actors View details

Flu A&B/RSV Ag Combo Rapid Test Cassette (Swab)

GCFR-T502a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCFR-T502a4G
Basic UDI-DI: B-GCFR-T502a4G
Reference: GCFR-T502a
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:27

Manufacturer products Authorised representative products Authorised representative actors View details