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639 device results listed.

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Leishmania Ab Rapid Test Cassette (Whole Blood/Serum/Plasma)

GCKal-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCKal-402aNM
Basic UDI-DI: B-GCKal-402aNM
Reference: GCKal-402a
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

Leishmania Ab Rapid Test Strip (Whole Blood/Serum/Plasma)

GCKal-401a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCKal-401aNJ
Basic UDI-DI: B-GCKal-401aNJ
Reference: GCKal-401a
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

Hantavirus IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)

GCHV(IgM)-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCHV(IgM)-402aVU
Basic UDI-DI: B-GCHV(IgM)-402aVU
Reference: GCHV(IgM)-402a
EMDN: W0105040614
EMDN description: HANTAVIRUS / BUNYAVIRUS
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

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

GCHV(IgG/IgM)-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCHV(IgG/IgM)-402aLS
Basic UDI-DI: B-GCHV(IgG/IgM)-402aLS
Reference: GCHV(IgG/IgM)-402a
EMDN: W0105040614
EMDN description: HANTAVIRUS / BUNYAVIRUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:28

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HSV IgM Rapid Test Cassette (Whole blood/Serum/Plasma)

GCHSV(IgM)-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCHSV(IgM)-402aX7
Basic UDI-DI: B-GCHSV(IgM)-402aX7
Reference: GCHSV(IgM)-402a
EMDN: W0105040304
EMDN description: HSV 1+2 IGM
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

HSV IgM Rapid Test Cassette (Serum/Plasma)

GCHSV(IgM)-302a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCHSV(IgM)-302aWY
Basic UDI-DI: B-GCHSV(IgM)-302aWY
Reference: GCHSV(IgM)-302a
EMDN: W0105040304
EMDN description: HSV 1+2 IGM
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

HSV IgG Rapid Test Cassette (Whole blood/Serum/Plasma)

GCHSV(IgG)-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCHSV(IgG)-402aTZ
Basic UDI-DI: B-GCHSV(IgG)-402aTZ
Reference: GCHSV(IgG)-402a
EMDN: W0105040303
EMDN description: HSV 1+2 IGG
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:28

Manufacturer products Authorised representative products Authorised representative actors View details

HSV IgG Rapid Test Cassette (Serum/Plasma)

GCHSV(IgG)-302a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCHSV(IgG)-302aTS
Basic UDI-DI: B-GCHSV(IgG)-302aTS
Reference: GCHSV(IgG)-302a
EMDN: W0105040303
EMDN description: HSV 1+2 IGG
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

Human Papillomavirus E7 Protein Rapid Test Cassette (Swab)

GCHPV-502a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCHPV-502a7S
Basic UDI-DI: B-GCHPV-502a7S
Reference: GCHPV-502a
EMDN: W0105041099
EMDN description: HPV REAGENTS - OTHER
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

H. pylori Ag Control Kit

GCHP-PN2

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCHP-PN2K6
Basic UDI-DI: B-GCHP-PN2K6
Reference: GCHP-PN2
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
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

H.pylori Ag Rapid Test Device (Feces)

GCHP-606a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCHP-606aZP
Basic UDI-DI: B-GCHP-606aZP
Reference: GCHP-606a
EMDN: W0105010401
EMDN description: H. PYLORI ANTIGEN DETECTION
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

H. pylori Ag Rapid Test Cassette (Feces)

GCHP-602a，GCHP-602Ca

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCHP-602CJ
Basic UDI-DI: B-GCHP-602CJ
Reference: GCHP-602a，GCHP-602Ca
EMDN: W0105010401
EMDN description: H. PYLORI ANTIGEN DETECTION
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

H. pylori Ag Rapid Test Strip (Feces)

GCHP-601a，GCHP-601Ca

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCHP-601CG
Basic UDI-DI: B-GCHP-601CG
Reference: GCHP-601a，GCHP-601Ca
EMDN: W0105010401
EMDN description: H. PYLORI ANTIGEN DETECTION
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

H. pylori Ab Rapid Test Cassette (Whole blood/Serum/Plasma)

GCHP-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCHP-402aYV
Basic UDI-DI: B-GCHP-402aYV
Reference: GCHP-402a
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:27

Manufacturer products Authorised representative products Authorised representative actors View details

H. pylori Ab Rapid Test Strip (Whole blood/Serum/Plasma)

GCHP-401a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCHP-401aYS
Basic UDI-DI: B-GCHP-401aYS
Reference: GCHP-401a
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:27

Manufacturer products Authorised representative products Authorised representative actors View details

H. pylori Ab Rapid Test Cassette (Serum/Plasma)

GCHP-302a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCHP-302aYN
Basic UDI-DI: B-GCHP-302aYN
Reference: GCHP-302a
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:27

Manufacturer products Authorised representative products Authorised representative actors View details

H. pylori Ab Rapid Test Strip (Serum/Plasma)

GCHP-301a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCHP-301aYK
Basic UDI-DI: B-GCHP-301aYK
Reference: GCHP-301a
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:27

Manufacturer products Authorised representative products Authorised representative actors View details

HEV IgM Rapid Test Cassette (Serum/Plasma)

GCHEV-302a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCHEV-302aZE
Basic UDI-DI: B-GCHEV-302aZE
Reference: GCHEV-302a
EMDN: W0105020505
EMDN description: HEV ANTIBODY IGM
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:27

Manufacturer products Authorised representative products Authorised representative actors View details

HAV Ag Rapid Test Cassette (Feces)

GCHAV-602a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCHAV-602aXX
Basic UDI-DI: B-GCHAV-602aXX
Reference: GCHAV-602a
EMDN: W0105020101
EMDN description: HAV ANTIGEN CONFIRMATORY
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:27

Manufacturer products Authorised representative products Authorised representative actors View details

HAV IgM Rapid Test Cassette (Serum/Plasma)

GCHAV(IgM)-302Ba

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCHAV(IgM)-302BaVF
Basic UDI-DI: B-GCHAV(IgM)-302BaVF
Reference: GCHAV(IgM)-302Ba
EMDN: W0105020104
EMDN description: HAV ANTIBODY IGM
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:27

Manufacturer products Authorised representative products Authorised representative actors View details