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562 device results listed.

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TRUPCR® Toxoplasma Real-Time PCR Detection kit

TRUPCR® Toxoplasma Real-Time PCR Detection Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08906213930238
Basic UDI-DI: 89080153043B279P2
Reference: 3B280
EMDN: W0105050105
EMDN description: TOXOPLASMA - NA REAGENTS
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 03.07.2026 22:03

Manufacturer products Authorised representative products Authorised representative actors View details

STRONGYLOIDES STERCORALIS VIRCLIA® IgG MONOTEST

VCM107

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

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436610290487
Basic UDI-DI: 843661029VCM10701LW
Reference: VCM107
EMDN: W0105050299
EMDN description: PARASITOLOGY - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 14:58

Manufacturer products View details

Aptima Trichomonas vaginalis Assay

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045505483
Basic UDI-DI: 54200455DIAGAPTTRICHWY
Reference: 303163
EMDN: W0105050310
EMDN description: TRICHOMONAS - NA REAGENTS
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 02.07.2026 04:05

Manufacturer products Authorised representative products Authorised representative actors View details

CL AIA-PACK Toxo IgM TEST CUP

CL AIA-PACK Toxo IgM

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 14560189216010
Basic UDI-DI: 45601892100010737K
Reference: 0029162
EMDN: W0105050103
EMDN description: TOXOPLASMA ANTIBODY IGM
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 01.07.2026 23:57

Manufacturer products Authorised representative products Authorised representative actors View details

04049095210099

RIDA®UNITY Parasitic Stool Panel II

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

Manufacturer: R-Biopharm AG
Manufacturer SRN: DE-MF-000007993
UDI-DI: 04049095210099
Basic UDI-DI: 4049095UN17250000SF
Reference: UN1725
EMDN: W0105050299
EMDN description: PARASITOLOGY - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:52

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

04049095030055

RIDASCREEN® Cryptosporidium

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

Manufacturer: R-Biopharm AG
Manufacturer SRN: DE-MF-000007993
UDI-DI: 04049095030055
Basic UDI-DI: 4049095C120100000GN
Reference: C1201
EMDN: W0105050207
EMDN description: CRYPTOSPORIDIUM
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:49

Manufacturer products View details

04049095030048

RIDASCREEN® Giardia

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

Manufacturer: R-Biopharm AG
Manufacturer SRN: DE-MF-000007993
UDI-DI: 04049095030048
Basic UDI-DI: 4049095C110100000G3
Reference: C1101
EMDN: W0105050208
EMDN description: GIARDIA LAMBLIA
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:49

Manufacturer products View details

E.L.I.H.A TOXO

66610

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

Manufacturer: ELITECH MICROBIO
Manufacturer SRN: FR-MF-000025235
UDI-DI: 03661540100680
Basic UDI-DI: 3661540PARhemag017C
Reference: 66610
EMDN: W0105050101
EMDN description: TOXOPLASMA ANTIBODY (TOTAL)
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 13:23

Manufacturer products View details

ELI.H.A Echinococcus

66604

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: ELITECH MICROBIO
Manufacturer SRN: FR-MF-000025235
UDI-DI: 03661540100666
Basic UDI-DI: 3661540PARhemag027E
Reference: 66604
EMDN: W0105050204
EMDN description: ECHINOCOCCUS
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 13:22

Manufacturer products View details

VIDAS® TOXO IgM

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026634902
Basic UDI-DI: 357302BUDI002209TL
Reference: 424641
EMDN: W0105050103
EMDN description: TOXOPLASMA ANTIBODY IGM
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 12:44

Manufacturer products View details

BIOSYNEX AMPLIFLASH MALARIA

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

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000014073
UDI-DI: 03532678607740
Basic UDI-DI: 353267F00191P8Q
Reference: 3150053
EMDN: W0105050309
EMDN description: PLASMODIUM (MALARIA) - NA REAGENTS
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 12:27

Manufacturer products View details

BIOSYNEX AMPLIQUICK Malaria

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

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000014073
UDI-DI: 03532678604220
Basic UDI-DI: 353267F00094P8S
Reference: 3120019_SEC01
EMDN: W0105050309
EMDN description: PLASMODIUM (MALARIA) - NA REAGENTS
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 12:26

Manufacturer products View details

GeneProof Trichomonas vaginalis PCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08595696301699
Basic UDI-DI: 859569630026QK
Reference: TV/GP/025
EMDN: W0105050310
EMDN description: TRICHOMONAS - NA REAGENTS
First on market country: Czechia
Authorised representative: -
Last updated: 30.06.2026 16:59

Manufacturer products View details

GeneProof Trichomonas vaginalis PCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08595696301682
Basic UDI-DI: 859569630026QK
Reference: TV/GP/100
EMDN: W0105050310
EMDN description: TRICHOMONAS - NA REAGENTS
First on market country: Czechia
Authorised representative: -
Last updated: 30.06.2026 16:59

Manufacturer products View details

Accu-Tell® Giardia lamblia Cassette (Feces)

Cassette

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AccuBioTech Co., Ltd.
Manufacturer SRN: CN-MF-000025172
UDI-DI: 06970581432245
Basic UDI-DI: B-06970581432245
Reference: ABT-IDT-B255
EMDN: W0105050208
EMDN description: GIARDIA LAMBLIA
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

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

Accu-Tell® Chagas Cassette(Whole Blood/Serum/Plasma)

Cassette

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AccuBioTech Co., Ltd.
Manufacturer SRN: CN-MF-000025172
UDI-DI: 06970581432221
Basic UDI-DI: B-06970581432221
Reference: ABT-IDT-B219
EMDN: W0105050202
EMDN description: CHAGAS
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

Toxo IgG CLIA Microparticles

Autolumo analyzer

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06970150908850
Basic UDI-DI: 697015090000104GV
Reference: CMK0602
EMDN: W0105050102
EMDN description: TOXOPLASMA ANTIBODY IGG
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 29.06.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details

Toxo IgM CLIA Microparticles

Autoluno analyzer

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06970150908805
Basic UDI-DI: 697015090000099HV
Reference: CMK0102
EMDN: W0105050103
EMDN description: TOXOPLASMA ANTIBODY IGM
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 29.06.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details