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

Last updated

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50 device results listed.

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Zika Rapid Test

Zika Rapid Test

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Zhejiang Anji Saianfu Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045029
UDI-DI: 69743840311242
Basic UDI-DI: B-69743840311242
Reference: 3023903
EMDN: W0105040630
EMDN description: ZIKA VIRUS
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 17.07.2026 04:12

Manufacturer products Authorised representative products Authorised representative actors View details

+ENTIZVM0790DS0C

NovaLisa® Zika Virus IgM μ-capture

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIZVM0790DS0C
Basic UDI-DI: B-+ENTIZVM0790DS0C
Reference: ZVM0790DS
EMDN: W0105040630
EMDN description: ZIKA VIRUS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:20

Manufacturer products View details

NovaLisa® Zika Virus IgM μ-capture

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIZVM07900E
Basic UDI-DI: B-+ENTIZVM07900E
Reference: ZVM0790
EMDN: W0105040630
EMDN description: ZIKA VIRUS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:20

Manufacturer products View details

+ENTIZVG0790DS06

NovaLisa® Zika Virus IgG capture

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIZVG0790DS06
Basic UDI-DI: B-+ENTIZVG0790DS06
Reference: ZVG0790DS
EMDN: W0105040630
EMDN description: ZIKA VIRUS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:20

Manufacturer products View details

NovaLisa® Zika Virus IgG capture

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIZVG079008
Basic UDI-DI: B-+ENTIZVG079008
Reference: ZVG0790
EMDN: W0105040630
EMDN description: ZIKA VIRUS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:20

Manufacturer products View details

+ENTIEIA-59840E

Zika Virus IgG capture ELISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIEIA-59840E
Basic UDI-DI: B-+ENTIEIA-59840E
Reference: EIA-5984
EMDN: W0105040630
EMDN description: ZIKA VIRUS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:13

Manufacturer products View details

+ENTIEIA-59080A

Zika Virus IgM μ-capture ELISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIEIA-59080A
Basic UDI-DI: B-+ENTIEIA-59080A
Reference: EIA-5908
EMDN: W0105040630
EMDN description: ZIKA VIRUS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:13

Manufacturer products View details

+ENTI301134410D

Zika Virus IgM μ-capture

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTI301134410D
Basic UDI-DI: B-+ENTI301134410D
Reference: 30113441
EMDN: W0105040630
EMDN description: ZIKA VIRUS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:05

Manufacturer products View details

Zika Virus IgG/IgM Antibody Rapid Test Kit

Zika Virus IgG/IgM Antibody 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-GKPD120X4
Basic UDI-DI: B-GKPD120X4
Reference: GKPD120
EMDN: W0105040630
EMDN description: ZIKA VIRUS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 14.07.2026 00:37

Manufacturer products Authorised representative products Authorised representative actors View details

Zika NS1 Ag Rapid Test Cassette(Whole blood/Serum/Plasma)

GCZIK(NS1)-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCZIK(NS1)-402aHGK4
Basic UDI-DI: B-GCZIK(NS1)-402aHGK4
Reference: GCZIK(NS1)-402a
EMDN: W0105040630
EMDN description: ZIKA VIRUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:33

Manufacturer products Authorised representative products Authorised representative actors View details

Zika NS1 Ag Rapid Test Cassette(Whole blood/Serum/Plasma)

GCZIK(NS1)-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCZIK(NS1)-402aCD
Basic UDI-DI: B-GCZIK(NS1)-402aCD
Reference: GCZIK(NS1)-402a
EMDN: W0105040630
EMDN description: ZIKA VIRUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:33

Manufacturer products Authorised representative products Authorised representative actors View details

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

GCZIK(IgG/IgM)-T402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCZIK(IgG/IgM)-T402aHDG
Basic UDI-DI: B-GCZIK(IgG/IgM)-T402aHDG
Reference: GCZIK(IgG/IgM)-T402a
EMDN: W0105040630
EMDN description: ZIKA VIRUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:33

Manufacturer products Authorised representative products Authorised representative actors View details

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

GCZIK(IgG/IgM)-T402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCZIK(IgG/IgM)-T402a3U
Basic UDI-DI: B-GCZIK(IgG/IgM)-T402a3U
Reference: GCZIK(IgG/IgM)-T402a
EMDN: W0105040630
EMDN description: ZIKA VIRUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:33

Manufacturer products Authorised representative products Authorised representative actors View details

Zika IgG Rapid Test Cassette (Whole Blood/Serum/Plasma)

GCZIK(IgG)-402b

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCZIK(IgG)-402bUW
Basic UDI-DI: B-GCZIK(IgG)-402bUW
Reference: GCZIK(IgG)-402b
EMDN: W0105040630
EMDN description: ZIKA VIRUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:33

Manufacturer products Authorised representative products Authorised representative actors View details

Zika IgG Rapid Test Cassette (Whole Blood/Serum/Plasma)

GCZIK(IgG)-402b

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCZIK(IgG)-402bHGB7
Basic UDI-DI: B-GCZIK(IgG)-402bHGB7
Reference: GCZIK(IgG)-402b
EMDN: W0105040630
EMDN description: ZIKA VIRUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:33

Manufacturer products Authorised representative products Authorised representative actors View details

RapidFor™ Zika IgG/IgM Rapid Test Kit (FIA)

VMPO76

IVD generalIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595030165
Basic UDI-DI: B-08684595030165
Reference: VMPO76
EMDN: W0105040630
EMDN description: ZIKA VIRUS
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 06:12

Manufacturer products View details

RapidFor™ Zika IgM Rapid Test Kit

VMD43

IVD generalIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683347941490
Basic UDI-DI: B-08683347941490
Reference: VMD43
EMDN: W0105040630
EMDN description: ZIKA VIRUS
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 00:04

Manufacturer products View details

ZIKVM.CE

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIA.PRO DIAGNOSTIC BIOPROBES S.R.L.
Manufacturer SRN: IT-MF-000029123
UDI-DI: 08050616041081
Basic UDI-DI: B-08050616041081
Reference: ZIKVM.CE
EMDN: W0105040630
EMDN description: ZIKA VIRUS
First on market country: Italy
Authorised representative: -
Last updated: 07.07.2026 19:10

Manufacturer products View details

Zika NS1 Rapid Test

GIZNS1

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Greylynx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032462
UDI-DI: 06976202763392
Basic UDI-DI: B-06976202763392
Reference: GIZNS1-402
EMDN: W0105040630
EMDN description: ZIKA VIRUS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 07.07.2026 00:40

Manufacturer products Authorised representative products Authorised representative actors View details

Zika IgG/IgM Rapid Test

GIZGM

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Greylynx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032462
UDI-DI: 06976202763385
Basic UDI-DI: B-06976202763385
Reference: GIZGM-422
EMDN: W0105040630
EMDN description: ZIKA VIRUS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 07.07.2026 00:40

Manufacturer products Authorised representative products Authorised representative actors View details