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639 device results listed.

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RSV Antigen Control Kit

GCRSV-PN2，GCRSV-PN10

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCRSV-PNVK
Basic UDI-DI: B-GCRSV-PNVK
Reference: GCRSV-PN2，GCRSV-PN10
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:30

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Rotavirus and Adenovirus Antigen Control Kit

GCROA/ADE-PN2

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCROA/ADE-PN2QK
Basic UDI-DI: B-GCROA/ADE-PN2QK
Reference: GCROA/ADE-PN2
EMDN: W0105080807
EMDN description: MULTICONSTITUENT CONTROLS - INF.IMM.
First on market country: Greece
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:30

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Rotavirus and Adenovirus Combo Rapid Test Cassette (Feces)

GCROA/ADE-602a

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCROA/ADE-602aRF
Basic UDI-DI: B-GCROA/ADE-602aRF
Reference: GCROA/ADE-602a
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Austria
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:30

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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

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Norovirus Antigen Rapid Test Cassette (Feces)

GCNOR-602a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCNOR-602a9E
Basic UDI-DI: B-GCNOR-602a9E
Reference: GCNOR-602a
EMDN: W0105040616
EMDN description: NOROVIRUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:29

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M. pneumoniae Ag Rapid Test Cassette (Swab)

GCMP-502a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCMP-502a3U
Basic UDI-DI: B-GCMP-502a3U
Reference: GCMP-502a
EMDN: W0105010801
EMDN description: MYCOPLASMA ANTIGEN DETECTION
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:29

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M. pneumonia IgM Rapid Test Cassette (Serum/Plasma)

GCMP(IgM)-302a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCMP(IgM)-302aVL
Basic UDI-DI: B-GCMP(IgM)-302aVL
Reference: GCMP(IgM)-302a
EMDN: W0105010802
EMDN description: MYCOPLASMA ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:29

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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

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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

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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 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

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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

Malaria Pf/Pv Ab Rapid Test Cassette (whole blood/serum/plasma)

GCMAL(pf/pv Ab)-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCMAL(pf/pvAb)-402aAB
Basic UDI-DI: B-GCMAL(pf/pvAb)-402aAB
Reference: GCMAL(pf/pv Ab)-402a
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - 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

Malaria Pf/Pv Ab Rapid Test Cassette (Serum/Plasma)

GCMAL(pf/pv Ab)-302a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCMAL(pf/pvAb)-302aA4
Basic UDI-DI: B-GCMAL(pf/pvAb)-302aA4
Reference: GCMAL(pf/pv Ab)-302a
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - 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

Malaria P.f./P.v. Ag Rapid Test Cassette (Whole Blood)

GCMAL(pf/pv)-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCMAL(pf/pv)-402aTT
Basic UDI-DI: B-GCMAL(pf/pv)-402aTT
Reference: GCMAL(pf/pv)-402a
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - 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

Malaria P.f./Pan Ag Rapid Test Cassette (Whole Blood)

GCMAL(pf/pan)-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCMAL(pf/pan)-402aBS
Basic UDI-DI: B-GCMAL(pf/pan)-402aBS
Reference: GCMAL(pf/pan)-402a
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - 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

Malaria P.f. Ag Rapid Test Casssette (Whole Blood)

GCMAL(pf)-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCMAL(pf)-402a83
Basic UDI-DI: B-GCMAL(pf)-402a83
Reference: GCMAL(pf)-402a
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:29

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria Pan Ag Rapid Test Cassette (Whole Blood)

GCMAL(pan)-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCMAL(pan)-402aAX
Basic UDI-DI: B-GCMAL(pan)-402aAX
Reference: GCMAL(pan)-402a
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - 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

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

GCLEP(IgG/IgM)-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCLEP(IgG/IgM)-402aRF
Basic UDI-DI: B-GCLEP(IgG/IgM)-402aRF
Reference: GCLEP(IgG/IgM)-402a
EMDN: W0105011704
EMDN description: LEPTOSPIRA
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:28

Manufacturer products Authorised representative products Authorised representative actors View details

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

GCKal-T402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCKal-T402aYL
Basic UDI-DI: B-GCKal-T402aYL
Reference: GCKal-T402a
EMDN: W0105050205
EMDN description: LEISHMANIA
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:28

Manufacturer products Authorised representative products Authorised representative actors View details