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308 device results listed.

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+ENTIFIL0760DS0I

NovaLisa® Filariasis

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIFIL0760DS0I
Basic UDI-DI: B-+ENTIFIL0760DS0I
Reference: FIL0760DS
EMDN: W0105050299
EMDN description: PARASITOLOGY - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:14

Manufacturer products View details

+ENTIFIL07600K

NovaLisa® Filariasis

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIFIL07600K
Basic UDI-DI: B-+ENTIFIL07600K
Reference: FIL0760
EMDN: W0105050299
EMDN description: PARASITOLOGY - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:14

Manufacturer products View details

+ENTIENTG0140DS0_

NovaLisa® Entamoeba histolytica IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIENTG0140DS0_
Basic UDI-DI: B-+ENTIENTG0140DS0_
Reference: ENTG0140DS
EMDN: W0105050201
EMDN description: ENTAMOEBA HISTOLYTICA
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:13

Manufacturer products View details

+ENTIENTG01400/

NovaLisa® Entamoeba histolytica IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIENTG01400/
Basic UDI-DI: B-+ENTIENTG01400/
Reference: ENTG0140
EMDN: W0105050201
EMDN description: ENTAMOEBA HISTOLYTICA
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:13

Manufacturer products View details

+ENTIEIA-581305

Chagas (Trypanosoma cruzi) IgG ELISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIEIA-581305
Basic UDI-DI: B-+ENTIEIA-581305
Reference: EIA-5813
EMDN: W0105050202
EMDN description: CHAGAS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:13

Manufacturer products View details

+ENTIEIA-551100

Malaria ELISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIEIA-551100
Basic UDI-DI: B-+ENTIEIA-551100
Reference: EIA-5511
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:13

Manufacturer products View details

+ENTIEIA-384306

Leishmania infantum IgG ELISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIEIA-384306
Basic UDI-DI: B-+ENTIEIA-384306
Reference: EIA-3843
EMDN: W0105050205
EMDN description: LEISHMANIA
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:12

Manufacturer products View details

+ENTIECHG0130DS0E

NovaLisa® Echinococcus IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIECHG0130DS0E
Basic UDI-DI: B-+ENTIECHG0130DS0E
Reference: ECHG0130DS
EMDN: W0105050204
EMDN description: ECHINOCOCCUS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:12

Manufacturer products View details

+ENTIECHG01300G

NovaLisa® Echinococcus IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIECHG01300G
Basic UDI-DI: B-+ENTIECHG01300G
Reference: ECHG0130
EMDN: W0105050204
EMDN description: ECHINOCOCCUS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:12

Manufacturer products View details

+ENTIDENO01140X

Chagas (Trypanosoma cruzi) IgG ELISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIDENO01140X
Basic UDI-DI: B-+ENTIDENO01140X
Reference: DENO0114
EMDN: W0105050202
EMDN description: CHAGAS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:11

Manufacturer products View details

+ENTIDEIG03100I

Leishmania infantum IgG ELISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIDEIG03100I
Basic UDI-DI: B-+ENTIDEIG03100I
Reference: DEIG0310
EMDN: W0105050205
EMDN description: LEISHMANIA
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:11

Manufacturer products View details

+ENTICHAG0560DS0H

NovaLisa® Chagas (Trypanosoma cruzi) IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTICHAG0560DS0H
Basic UDI-DI: B-+ENTICHAG0560DS0H
Reference: CHAG0560DS
EMDN: W0105050202
EMDN description: CHAGAS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:09

Manufacturer products View details

+ENTICHAG05600J

NovaLisa® Chagas (Trypanosoma cruzi) IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTICHAG05600J
Basic UDI-DI: B-+ENTICHAG05600J
Reference: CHAG0560
EMDN: W0105050202
EMDN description: CHAGAS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:09

Manufacturer products View details

+ENTIASCG0020DS0J

NovaLisa® Ascaris lumbricoides IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIASCG0020DS0J
Basic UDI-DI: B-+ENTIASCG0020DS0J
Reference: ASCG0020DS
EMDN: W0105050299
EMDN description: PARASITOLOGY - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:08

Manufacturer products View details

+ENTIASCG00200L

NovaLisa® Ascaris lumbricoides IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIASCG00200L
Basic UDI-DI: B-+ENTIASCG00200L
Reference: ASCG0020
EMDN: W0105050299
EMDN description: PARASITOLOGY - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:08

Manufacturer products View details

+ENTI301140790L

Schistosoma mansoni IgM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTI301140790L
Basic UDI-DI: B-+ENTI301140790L
Reference: 30114079
EMDN: W0105050206
EMDN description: SCHISTOSOMA
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:06

Manufacturer products View details

+ENTI301136230F

Echinococcus IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTI301136230F
Basic UDI-DI: B-+ENTI301136230F
Reference: 30113623
EMDN: W0105050204
EMDN description: ECHINOCOCCUS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:05

Manufacturer products View details

COR

BD Enteric Bacterial Panel Diluent for BD COR™

IVD Class AIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Becton, Dickinson and Company
Manufacturer SRN: US-MF-000018910
UDI-DI: 30382904452798
Basic UDI-DI: 038290FIJFRVAY7J
Reference: 445279
EMDN: W0105050208
EMDN description: GIARDIA LAMBLIA
First on market country: Belgium
Authorised representative: Becton Dickinson Ireland Limited
Last updated: 15.07.2026 23:39

Manufacturer products Authorised representative products Authorised representative actors View details

Plasmodium Genotyping Real Time PCR Ki

YJW20601NW-50T

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Jiangsu Bioperfectus Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000014691
UDI-DI: D-YJW20601NW-50TQL
Basic UDI-DI: B-YJW20601NW-50TQL
Reference: YJW20601NW-50T
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 15.07.2026 14:12

Manufacturer products Authorised representative products Authorised representative actors View details

Plasmodium Genotyping Real Time PCR K

YJW20601NW-25T

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Jiangsu Bioperfectus Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000014691
UDI-DI: D-YJW20601NW-25TQL
Basic UDI-DI: B-YJW20601NW-25TQL
Reference: YJW20601NW-25T
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 15.07.2026 14:12

Manufacturer products Authorised representative products Authorised representative actors View details