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496 device results listed.

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Entamoeba histolytica Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IEH-R602AY
Basic UDI-DI: B-IEH-R602AY
Reference: IEH-R602
EMDN: W0105050201
EMDN description: ENTAMOEBA HISTOLYTICA
First on market country: Austria
Authorised representative: VidaQuick Biotech S.L.
Last updated: 14.07.2026 01:05

Manufacturer products Authorised representative products Authorised representative actors View details

Cryptosporidium Antigen Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-ICR-R602DY
Basic UDI-DI: B-ICR-R602DY
Reference: ICR-R602
EMDN: W0105050207
EMDN description: CRYPTOSPORIDIUM
First on market country: Austria
Authorised representative: VidaQuick Biotech S.L.
Last updated: 14.07.2026 01:05

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Chagas Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-ICHA-R402YF
Basic UDI-DI: B-ICHA-R402YF
Reference: ICHA-R402
EMDN: W0105050202
EMDN description: CHAGAS
First on market country: Austria
Authorised representative: VidaQuick Biotech S.L.
Last updated: 14.07.2026 01:04

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Chagas Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-ICHA-R302YA
Basic UDI-DI: B-ICHA-R302YA
Reference: ICHA-R302
EMDN: W0105050202
EMDN description: CHAGAS
First on market country: Austria
Authorised representative: VidaQuick Biotech S.L.
Last updated: 14.07.2026 01:04

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Toxoplasma gondii 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-GKPD140XA
Basic UDI-DI: B-GKPD140XA
Reference: GKPD140
EMDN: W0105050101
EMDN description: TOXOPLASMA ANTIBODY (TOTAL)
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 14.07.2026 00:38

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Trichomonas vaginalis 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-GKPD137XM
Basic UDI-DI: B-GKPD137XM
Reference: GKPD137
EMDN: W0105050210
EMDN description: TRICHOMONAS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 14.07.2026 00:38

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Trichomonas Ag Rapid Test Cassette (Swab)

GCTV-502a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCTV-502aHG3D
Basic UDI-DI: B-GCTV-502aHG3D
Reference: GCTV-502a
EMDN: W0105050210
EMDN description: TRICHOMONAS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:32

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Trichomonas Ag Rapid Test Cassette (Swab)

GCTV-502a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCTV-502a9Z
Basic UDI-DI: B-GCTV-502a9Z
Reference: GCTV-502a
EMDN: W0105050210
EMDN description: TRICHOMONAS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:32

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Toxoplasma gondii (Toxo) IgM Rapid Test

GCTOX(IgM)-302a

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-GCTOX(IgM)-302aBR
Basic UDI-DI: B-GCTOX(IgM)-302aBR
Reference: GCTOX(IgM)-302a
EMDN: W0105050103
EMDN description: TOXOPLASMA ANTIBODY IGM
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:32

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Toxoplasma gondii (Toxo) IgG/IgM Rapid Test

GCTOX(IgG/IgM)-302a

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-GCTOX(IgG/IgM)-302a4G
Basic UDI-DI: B-GCTOX(IgG/IgM)-302a4G
Reference: GCTOX(IgG/IgM)-302a
EMDN: W0105050101
EMDN description: TOXOPLASMA ANTIBODY (TOTAL)
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:32

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Toxoplasma gondii (Toxo) IgG Rapid Test

GCTOX(IgG)-302a

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-GCTOX(IgG)-302a8K
Basic UDI-DI: B-GCTOX(IgG)-302a8K
Reference: GCTOX(IgG)-302a
EMDN: W0105050102
EMDN description: TOXOPLASMA ANTIBODY IGG
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:32

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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

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

GCKal-T402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCKal-T402aHGQK
Basic UDI-DI: B-GCKal-T402aHGQK
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

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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 Cassette (Whole Blood/Serum/Plasma)

GCKal-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCKal-402aHGWR
Basic UDI-DI: B-GCKal-402aHGWR
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

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

GCKal-401a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCKal-401aHGWJ
Basic UDI-DI: B-GCKal-401aHGWJ
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

Giardia lamblia Antigen Rapid Test Cassette (Feces)

GCGIA-602a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCGIA-602aT3
Basic UDI-DI: B-GCGIA-602aT3
Reference: GCGIA-602a
EMDN: W0105050208
EMDN description: GIARDIA LAMBLIA
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

Giardia lamblia Antigen Rapid Test Cassette (Feces)

GCGIA-602a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCGIA-602aHGPM
Basic UDI-DI: B-GCGIA-602aHGPM
Reference: GCGIA-602a
EMDN: W0105050208
EMDN description: GIARDIA LAMBLIA
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

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

Manufacturer products Authorised representative products Authorised representative actors View details