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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

Influenza A & B Ag Rapid Test Cassette (Swab)

GCFLU(A/B)-502a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCFLU(A/B)-502aHG63
Basic UDI-DI: B-GCFLU(A/B)-502aHG63
Reference: GCFLU(A/B)-502a
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:26

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A & B Ag Rapid Test Cassette (Swab)

GCFLU(A/B)-502Ca

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCFLU(A/B)-502CaHGN5
Basic UDI-DI: B-GCFLU(A/B)-502CaHGN5
Reference: GCFLU(A/B)-502Ca
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:26

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A & B Ag Rapid Test Cassette (Swab)

GCFLU(A/B)-502a, GCFLU(A/B)-502Ca

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCFLU(A/B)-5024L
Basic UDI-DI: B-GCFLU(A/B)-5024L
Reference: GCFLU(A/B)-502a，GCFLU(A/B)-502Ca
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:26

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A & B Ag Rapid Test Strip (Swab)

GCFLU(A/B)-501a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCFLU(A/B)-501aHG5U
Basic UDI-DI: B-GCFLU(A/B)-501aHG5U
Reference: GCFLU(A/B)-501a
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:26

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A & B Ag Rapid Test Strip (Swab)

GCFLU(A/B)-501a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCFLU(A/B)-501aAB
Basic UDI-DI: B-GCFLU(A/B)-501aAB
Reference: GCFLU(A/B)-501a
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:26

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A Ag Rapid Test Strip (Swab)

GCFLU(A)-501a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCFLU(A)-501aWQ
Basic UDI-DI: B-GCFLU(A)-501aWQ
Reference: GCFLU(A)-501a
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:26

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19/Flu A/Flu B/RSV/ADV/M.P Ag Combo Rapid Test Cassette (Swab)

GCFCRAMP-T535a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCFCRAMP-T535aDE
Basic UDI-DI: B-GCFCRAMP-T535aDE
Reference: GCFCRAMP-T535a
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 00:26

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19/Flu A&B/RSV/Adeno Ag Combo Rapid Test Cassette (Swab)

GCFCRA-T525a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCFCRA-T525a8X
Basic UDI-DI: B-GCFCRA-T525a8X
Reference: GCFCRA-T525a
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 00:26

Manufacturer products Authorised representative products Authorised representative actors View details

Flu, COVID-19, RSV & Adeno Ag Combo Test Cassette (Swab)

GCFCRA-545a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCFCRA-545aWP
Basic UDI-DI: B-GCFCRA-545aWP
Reference: GCFCRA-545a
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 00:26

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19/Flu A&B/RSV Ag Combo Rapid Test Cassette (Swab)

GCFCR-T525a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCFCR-T525a3T
Basic UDI-DI: B-GCFCR-T525a3T
Reference: GCFCR-T525a
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 00:26

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 /Flu A&B /RSV Ag Combo Rapid Test Cassette (Swab)

GCFCR-T525a-NN

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCFCR-T525a-NNNG
Basic UDI-DI: B-GCFCR-T525a-NNNG
Reference: GCFCR-T525a-NN
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 00:26

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 /Flu A&B /RSV Ag Combo Rapid Test Cassette (Swab)

GCFCR-T525a-NN

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCFCR-T525a-NNHGR9
Basic UDI-DI: B-GCFCR-T525a-NNHGR9
Reference: GCFCR-T525a-NN
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 00:26

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19+Flu A&B+RSV Ag Combo Rapid Test Cassette (Swab)

GCFCR-T525Sa-DD

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCFCR-T525Sa-DD4H
Basic UDI-DI: B-GCFCR-T525Sa-DD4H
Reference: GCFCR-T525Sa-DD
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 00:26

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue NS1+IgM/IgG Combo Rapid Test Cassette (Whole Blood/Serum/Plasma)

GCDEN-425a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCDEN-425aHGSA
Basic UDI-DI: B-GCDEN-425aHGSA
Reference: GCDEN-425a
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:25

Manufacturer products Authorised representative products Authorised representative actors View details

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

GCDEN(ab)-402e

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCDEN(ab)-402eHGPF
Basic UDI-DI: B-GCDEN(ab)-402eHGPF
Reference: GCDEN(ab)-402e
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:25

Manufacturer products Authorised representative products Authorised representative actors View details