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598 device results listed.

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+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

+ENTIATOX74600N

NovaLisa® Avidity Toxoplasma gondii IgG

IVD Annex II List BIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIATOX74600N
Basic UDI-DI: B-+ENTIATOX74600N
Reference: ATOX7460
EMDN: W0105050104
EMDN description: TOXOPLASMA ANTIBODY IGG - AVIDITY
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:08

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

+ENTI301136250H

Toxoplasma gondii IgA

IVD Annex II List BIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTI301136250H
Basic UDI-DI: B-+ENTI301136250H
Reference: 30113625
EMDN: W0105050199
EMDN description: TOXOPLASMA REAGENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:05

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

VIASURE Trypanosoma cruzi Real Time PCR Detection Kit

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440209744
Basic UDI-DI: 84354402_MDXVECTOR_CHAH5
Reference: VS-CHA106L
EMDN: W0105050302
EMDN description: CHAGAS - NA REAGENTS
First on market country: Spain
Authorised representative: -
Last updated: 16.07.2026 12:19

Manufacturer products View details

ADVIA Centaur Toxoplasma M

IVDR_67_TTN_DUB-C_C_KIT_Toxo M

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414208442
Basic UDI-DI: 0405686901825W2
Reference: 10310320
EMDN: W0105050103
EMDN description: TOXOPLASMA ANTIBODY IGM
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:33

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE 2000 Toxoplasma IgM (µ-Capture)

IVDR_67_LLB_DUB-C_C_KIT_Toxoplasma IgM

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414972893
Basic UDI-DI: 0405686901465VS
Reference: 10381298
EMDN: W0105050103
EMDN description: TOXOPLASMA ANTIBODY IGM
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:27

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE 2000 Toxoplasma Quantitative IgG

IVDR_67_LLB_DUB-C_C_KIT_Toxoplasma Quantitative IgG

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414962238
Basic UDI-DI: 0405686901466VU
Reference: 10381323
EMDN: W0105050102
EMDN description: TOXOPLASMA ANTIBODY IGG
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:26

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur Toxoplasma G

IVDR_67_TTN_DUB-C_C_KIT_Toxo G

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414208459
Basic UDI-DI: 0405686900810VE
Reference: 10310321
EMDN: W0105050102
EMDN description: TOXOPLASMA ANTIBODY IGG
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:12

Manufacturer products Authorised representative products Authorised representative actors 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

Leishmania Real Time PCR Kit

YJB30123NW-50T

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Jiangsu Bioperfectus Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000014691
UDI-DI: D-YJB30123NW-50TXU
Basic UDI-DI: B-YJB30123NW-50TXU
Reference: YJB30123NW-50T
EMDN: W0105050205
EMDN description: LEISHMANIA
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 15.07.2026 14:03

Manufacturer products Authorised representative products Authorised representative actors View details