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23 device results listed.

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Entamoeba histolytica IgG ELISA

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: Bordier Affinity Products SA
Manufacturer SRN: CH-MF-000025247
UDI-DI: 07640158219553
Basic UDI-DI: 764015821955037
Reference: 9550
EMDN: W0105050201
EMDN description: ENTAMOEBA HISTOLYTICA
First on market country: France
Authorised representative: Leman Diagnostics SARL
Last updated: 31.07.2026 22:04

Manufacturer products Authorised representative products Authorised representative actors View details

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-602NV
Basic UDI-DI: B-IEH-602NV
Reference: IEH-602
EMDN: W0105050201
EMDN description: ENTAMOEBA HISTOLYTICA
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 21.07.2026 07:30

Manufacturer products Authorised representative products Authorised representative actors View details

+ENTIRE586310H

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: +ENTIRE586310H
Basic UDI-DI: B-+ENTIRE586310H
Reference: RE58631
EMDN: W0105050201
EMDN description: ENTAMOEBA HISTOLYTICA
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:19

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

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+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

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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

Accu-Tell® Entamoeba histolytica Strip (Feces)

Strip

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AccuBioTech Co., Ltd.
Manufacturer SRN: CN-MF-000025172
UDI-DI: D-ABT-IDT-A292VD
Basic UDI-DI: B-ABT-IDT-A292VD
Reference: ABT-IDT-A292
EMDN: W0105050201
EMDN description: ENTAMOEBA HISTOLYTICA
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 12.07.2026 21:26

Manufacturer products Authorised representative products Authorised representative actors View details

Entamoeba histolytica

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: NEOMEDICA DOO NIŠ
Manufacturer SRN: RS-MF-000021305
UDI-DI: 86060313275786
Basic UDI-DI: B-86060313275786
Reference: C1805V24EH
EMDN: W0105050201
EMDN description: ENTAMOEBA HISTOLYTICA
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 12.07.2026 10:15

Manufacturer products Authorised representative products Authorised representative actors View details

RapidFor™ Entamoeba histolytica Test Kit

VMD100TD

IVD generalIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685115800589
Basic UDI-DI: B-08685115800589
Reference: VMD100
EMDN: W0105050201
EMDN description: ENTAMOEBA HISTOLYTICA
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 06:22

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RapidFor™ Entamoeba Rapid Test Kit (FIA)

VMPO106

IVD generalIVDDOn the marketInstrumentKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595039175
Basic UDI-DI: B-08684595039175
Reference: VMPO106GD
EMDN: W0105050201
EMDN description: ENTAMOEBA HISTOLYTICA
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 06:17

Manufacturer products View details

LyoSens Cryptosporidium, Giardia & E. Histolytica Detection qPCR Kit

LYO32

IVD generalIVDDOn the marketCompanion diagnosticsInstrumentKitNear-patient testingProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548258861
Basic UDI-DI: B-08683548258861
Reference: LYO32
EMDN: W0105050201
EMDN description: ENTAMOEBA HISTOLYTICA
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 00:20

Manufacturer products View details

LyoSens Entamoeba histolytica Detection qPCR Kit

LYO19

IVD generalIVDDOn the marketCompanion diagnosticsInstrumentKitNear-patient testingProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548258731
Basic UDI-DI: B-08683548258731
Reference: LYO19
EMDN: W0105050201
EMDN description: ENTAMOEBA HISTOLYTICA
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 00:19

Manufacturer products View details

ChainFor™ Cryptosporidium + Giardia + E. Histolytica Detection qPCR Kit

CFP59

IVD generalIVDDOn the marketCompanion diagnosticsInstrumentKitNear-patient testingProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548257604
Basic UDI-DI: B-08683548257604
Reference: CFP59
EMDN: W0105050201
EMDN description: ENTAMOEBA HISTOLYTICA
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 00:16

Manufacturer products View details

ChainFor Entamoeba histolytica Detection qPCR Kit

CFP46

IVD generalIVDDOn the marketCompanion diagnosticsInstrumentKitNear-patient testingProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548257482
Basic UDI-DI: B-08683548257482
Reference: CFP46
EMDN: W0105050201
EMDN description: ENTAMOEBA HISTOLYTICA
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 00:16

Manufacturer products View details

RapidFor™ Entamoeba Rapid Test Kit

VMD69

IVD generalIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548251169
Basic UDI-DI: B-08683548251169
Reference: VMD69
EMDN: W0105050201
EMDN description: ENTAMOEBA HISTOLYTICA
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 00:11

Manufacturer products View details

PreventID® Entamoeba histolytica

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598013483
Basic UDI-DI: B-04050598013483
Reference: KSTIEH602GP
EMDN: W0105050201
EMDN description: ENTAMOEBA HISTOLYTICA
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:50

Manufacturer products View details

PreventID® Entamoeba histolytica

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598013476
Basic UDI-DI: B-04050598013476
Reference: KSTIEH602G10
EMDN: W0105050201
EMDN description: ENTAMOEBA HISTOLYTICA
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:50

Manufacturer products View details

04049095030086

RIDASCREEN® Entamoeba

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

Manufacturer: R-Biopharm AG
Manufacturer SRN: DE-MF-000007993
UDI-DI: 04049095030086
Basic UDI-DI: 4049095C170100000KM
Reference: C1701
EMDN: W0105050201
EMDN description: ENTAMOEBA HISTOLYTICA
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:50

Manufacturer products View details

Accu-Tell® Entamoeba Histolytica Cassette (Feces)

Cassette

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AccuBioTech Co., Ltd.
Manufacturer SRN: CN-MF-000025172
UDI-DI: 06970581432238
Basic UDI-DI: B-06970581432238
Reference: ABT-IDT-B292
EMDN: W0105050201
EMDN description: ENTAMOEBA HISTOLYTICA
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 30.06.2026 05:49

Manufacturer products Authorised representative products Authorised representative actors View details

04049095030239

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

Manufacturer: R-Biopharm AG
Manufacturer SRN: DE-MF-000007993
UDI-DI: 04049095030239
Basic UDI-DI: 4049095C170100000KM
Reference: CRP1704
EMDN: W0105050201
EMDN description: ENTAMOEBA HISTOLYTICA
First on market country: -
Authorised representative: -
Last updated: 16.06.2026 22:40

Manufacturer products View details