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A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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727 device results listed.

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Chlamydia Trachomatis Antigen Rapid Test (Cassette) (Swab/Urine)

GCCHL-502a

IVD Annex II List BIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCCHL-502aUE
Basic UDI-DI: B-GCCHL-502aUE
Reference: GCCHL-502a
EMDN: W0105010107
EMDN description: CHLAMYDIA TRACHOMATIS ANTIGEN DETECTION
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:23

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One Step Chikungunya Ag Test Cassette (Whole Blood/Serum/Plasma)

GCCHK-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCCHK-402aTS
Basic UDI-DI: B-GCCHK-402aTS
Reference: GCCHK-402a
EMDN: W0105040625
EMDN description: CHIKUNGUNYA VIRUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:23

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

GCCHK(IgM/IgG)-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCCHK(IgM/IgG)-402a94
Basic UDI-DI: B-GCCHK(IgM/IgG)-402a94
Reference: GCCHK(IgM/IgG)-402a
EMDN: W0105040625
EMDN description: CHIKUNGUNYA VIRUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:23

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

GCCHK(IgM)-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCCHK(IgM)-402aZB
Basic UDI-DI: B-GCCHK(IgM)-402aZB
Reference: GCCHK(IgM)-402a
EMDN: W0105040625
EMDN description: CHIKUNGUNYA VIRUS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:23

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Chikungunya IgM Rapid Test Cassette (Serum/Plasma)

GCCHK(IgM)-302a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCCHK(IgM)-302aZ4
Basic UDI-DI: B-GCCHK(IgM)-302aZ4
Reference: GCCHK(IgM)-302a
EMDN: W0105040625
EMDN description: CHIKUNGUNYA VIRUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:23

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

GCCHK(IgG/IgM)-402b

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCCHK(IgG/IgM)-402b6J
Basic UDI-DI: B-GCCHK(IgG/IgM)-402b6J
Reference: GCCHK(IgG/IgM)-402b
EMDN: W0105040625
EMDN description: CHIKUNGUNYA VIRUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:23

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

GCCHA-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCCHA-402aPQ
Basic UDI-DI: B-GCCHA-402aPQ
Reference: GCCHA-402a
EMDN: W0105050202
EMDN description: CHAGAS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:23

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Chagas Ab Rapid Test Cassette (Serum/Plasma)

GCCHA-302a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCCHA-302aPH
Basic UDI-DI: B-GCCHA-302aPH
Reference: GCCHA-302a
EMDN: W0105050202
EMDN description: CHAGAS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:23

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Clostridium difficile GDH & Toxin A/B Rapid Test Cassette (Feces)

GCCD-602a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCCD-602aRS
Basic UDI-DI: B-GCCD-602aRS
Reference: GCCD-602a
EMDN: W0105011803
EMDN description: C.DIFFICILE GDH AND TOXIN A/B COMBINED DETECTION
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:23

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Clostridium difficile Toxin A&B Rapid Test Casette (Feces)

GCCD(Toxin A/B)-602a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCCD(ToxinAB)-602aZC
Basic UDI-DI: B-GCCD(ToxinAB)-602aZC
Reference: GCCD(Toxin A/B)-602a
EMDN: W0105011802
EMDN description: C.DIFFICILE TOXIN A/B DETECTION
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:23

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Clostridium difficile Antigen GDH Rapid Test Cassette (Feces)

GCCD(GDH)-602a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCCD(GDH)-602aH3
Basic UDI-DI: B-GCCD(GDH)-602aH3
Reference: GCCD(GDH)-602a
EMDN: W0105011801
EMDN description: C.DIFFICILE GDH DETECTION
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:23

Manufacturer products Authorised representative products Authorised representative actors View details

Candida albicans Antigen Rapid Test Cassette (Swab)

GCCA-502a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCCA-502aQC
Basic UDI-DI: B-GCCA-502aQC
Reference: GCCA-502a
EMDN: W0105060302
EMDN description: CANDIDA ALBICANS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:23

Manufacturer products Authorised representative products Authorised representative actors View details

Brucella Antibody Rapid Test Cassette (Whole Blood/Serum/Plasma)

GCBRU-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCBRU-402a4N
Basic UDI-DI: B-GCBRU-402a4N
Reference: GCBRU-402a
EMDN: W0105011701
EMDN description: BRUCELLA
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:22

Manufacturer products Authorised representative products Authorised representative actors View details

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

GCBRU(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-GCBRU(IgG/IgM)-402a3Y
Basic UDI-DI: B-GCBRU(IgG/IgM)-402a3Y
Reference: GCBRU(IgG/IgM)-402a
EMDN: W0105011701
EMDN description: BRUCELLA
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:22

Manufacturer products Authorised representative products Authorised representative actors View details

Adenovirus Antigen Control Kit

GCADE-PN2

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCADE-PN23K
Basic UDI-DI: B-GCADE-PN23K
Reference: GCADE-PN2
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 00:22

Manufacturer products Authorised representative products Authorised representative actors View details

Adenovirus Rapid Test Cassette (Feces)

GCADE-602a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCADE-602aNG
Basic UDI-DI: B-GCADE-602aNG
Reference: GCADE-602a
EMDN: W0105040601
EMDN description: ADENOVIRUS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:22

Manufacturer products Authorised representative products Authorised representative actors View details

Adenovirus Antigen Rapid Test Cassette (Swab)

GCADE-502a

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCADE-502aN9
Basic UDI-DI: B-GCADE-502aN9
Reference: GCADE-502a
EMDN: W0105040601
EMDN description: ADENOVIRUS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:22

Manufacturer products Authorised representative products Authorised representative actors View details

Adenovirus Antigen Rapid Test Cassette (Swab)

GCADE-502Ca

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCADE-502CaFM
Basic UDI-DI: B-GCADE-502CaFM
Reference: GCADE-502Ca
EMDN: W0105040601
EMDN description: ADENOVIRUS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:22

Manufacturer products Authorised representative products Authorised representative actors View details

Hair Multi-Drug Rapid Test Kit (ICA)

GBXXX-1102

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GBXXX-1102J6
Basic UDI-DI: B-GBXXX-1102J6
Reference: GBXXX-1102
EMDN: W0102090199
EMDN description: DRUGS OF ABUSE - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:22

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Drugs of Abuse Test Dip Card (Urine)

GBXXX-105

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GBXXX-105NM
Basic UDI-DI: B-GBXXX-105NM
Reference: GBXXX-105
EMDN: W0102090199
EMDN description: DRUGS OF ABUSE - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:22

Manufacturer products Authorised representative products Authorised representative actors View details