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D-EIM4411117FQ

TOXO IgM Antibody Chemiluminescent Immunoassay Kit

IVD Annex II List BIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4411117FQ
Basic UDI-DI: B-EIM4411117FQ
Reference: EIM4411117
EMDN: W0105050103
EMDN description: TOXOPLASMA ANTIBODY IGM
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:58

Manufacturer products Authorised representative products Authorised representative actors View details

LDBIO TOXO II IgM

IVD Annex II List BIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: LDBIO DIAGNOSTICS
Manufacturer SRN: FR-MF-000021697
UDI-DI: D-377002779324327
Basic UDI-DI: B-377002779324327
Reference: T2M-96M
EMDN: W0105050103
EMDN description: TOXOPLASMA ANTIBODY IGM
First on market country: France
Authorised representative: -
Last updated: 11.07.2026 18:56

Manufacturer products View details

LDBIO TOXO II IgM

IVD Annex II List BIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: LDBIO DIAGNOSTICS
Manufacturer SRN: FR-MF-000021697
UDI-DI: D-37700277932362A
Basic UDI-DI: B-37700277932362A
Reference: T2M-24M
EMDN: W0105050103
EMDN description: TOXOPLASMA ANTIBODY IGM
First on market country: France
Authorised representative: -
Last updated: 11.07.2026 18:56

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LDBIO TOXO II IgM

IVD Annex II List BIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: LDBIO DIAGNOSTICS
Manufacturer SRN: FR-MF-000021697
UDI-DI: D-37700277932292D
Basic UDI-DI: B-37700277932292D
Reference: T2M-12M
EMDN: W0105050103
EMDN description: TOXOPLASMA ANTIBODY IGM
First on market country: France
Authorised representative: -
Last updated: 11.07.2026 18:56

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MONO-VIDITEST anti-Toxoplasma gondii IgM

IVD Annex II List BIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: VIDIA spol. s r.o.
Manufacturer SRN: CZ-MF-000036964
UDI-DI: 38594036042118
Basic UDI-DI: B-38594036042118
Reference: KZ-211-12
EMDN: W0105050103
EMDN description: TOXOPLASMA ANTIBODY IGM
First on market country: Czechia
Authorised representative: -
Last updated: 11.07.2026 18:54

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Access Toxo IgM II

IVD Annex II List BIVDDOn the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-34470GL
Basic UDI-DI: B-34470GL
Reference: 34470
EMDN: W0105050103
EMDN description: TOXOPLASMA ANTIBODY IGM
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 18:28

Manufacturer products Authorised representative products Authorised representative actors View details

ELISA-VIDITEST anti-Toxoplasma gondii IgM

IVD Annex II List BIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: VIDIA spol. s r.o.
Manufacturer SRN: CZ-MF-000036964
UDI-DI: 28594036044832
Basic UDI-DI: B-28594036044832
Reference: ODZ-483
EMDN: W0105050103
EMDN description: TOXOPLASMA ANTIBODY IGM
First on market country: Czechia
Authorised representative: -
Last updated: 11.07.2026 16:22

Manufacturer products View details

iFlash-Toxo IgM

IVD Class CNot specifiedOn the market

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912719045
Basic UDI-DI: 692591270102GS
Reference: C88030M
EMDN: W0105050103
EMDN description: TOXOPLASMA ANTIBODY IGM
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 11.07.2026 13:48

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-Toxo IgM

IVD Class CNot specifiedOn the market

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912723615
Basic UDI-DI: 692591270102GS
Reference: C88030M-S
EMDN: W0105050103
EMDN description: TOXOPLASMA ANTIBODY IGM
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 11.07.2026 13:38

Manufacturer products Authorised representative products Authorised representative actors View details

MONO-VIDITEST anti-Toxoplasma gondii IgM

IVD Annex II List BIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: VIDIA spol. s r.o.
Manufacturer SRN: CZ-MF-000036964
UDI-DI: 18594036042114
Basic UDI-DI: B-18594036042114
Reference: K-211-12
EMDN: W0105050103
EMDN description: TOXOPLASMA ANTIBODY IGM
First on market country: Czechia
Authorised representative: -
Last updated: 11.07.2026 10:25

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Atellica IM Toxoplasma IgM (Toxo M)

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414600147
Basic UDI-DI: 0405686901825W2
Reference: 10995701
EMDN: W0105050103
EMDN description: TOXOPLASMA ANTIBODY IGM
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 09.07.2026 22:44

Manufacturer products Authorised representative products Authorised representative actors View details

Toxo IgM CLIA Microparticles

IVD Class CNot specifiedOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359552066
Basic UDI-DI: 697015090000099HV
Reference: CMK0105
EMDN: W0105050103
EMDN description: TOXOPLASMA ANTIBODY IGM
First on market country: Türkiye
Authorised representative: QbD RepS BV
Last updated: 08.07.2026 19:38

Manufacturer products Authorised representative products Authorised representative actors View details

ELISA-VIDITEST anti-Toxoplasma gondii IgM

IVD Annex II List BIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: VIDIA spol. s r.o.
Manufacturer SRN: CZ-MF-000036964
UDI-DI: 08594036044838
Basic UDI-DI: B-08594036044838
Reference: OD-483
EMDN: W0105050103
EMDN description: TOXOPLASMA ANTIBODY IGM
First on market country: Czechia
Authorised representative: -
Last updated: 08.07.2026 01:45

Manufacturer products 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

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

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

Toxoplasma gondii IgM (CLIA)

IVD Class CNot specifiedOn the market

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053021302
Basic UDI-DI: 69449040004W-ToxoIgM***L5
Reference: 105-012534-00
EMDN: W0105050103
EMDN description: TOXOPLASMA ANTIBODY IGM
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 29.06.2026 14:11

Manufacturer products Authorised representative products Authorised representative actors View details

Toxoplasma gondii IgM (CLIA)

IVD Class CNot specifiedOn the market

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053021517
Basic UDI-DI: 69449040004W-ToxoIgM***L5
Reference: 105-012530-00
EMDN: W0105050103
EMDN description: TOXOPLASMA ANTIBODY IGM
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 29.06.2026 14:11

Manufacturer products Authorised representative products Authorised representative actors View details

Toxoplasma gondii IgM (CLIA)

IVD Class CNot specifiedOn the market

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053021616
Basic UDI-DI: 69449040004W-ToxoIgM***L5
Reference: 105-012531-00
EMDN: W0105050103
EMDN description: TOXOPLASMA ANTIBODY IGM
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 29.06.2026 14:11

Manufacturer products Authorised representative products Authorised representative actors View details

Neonatal Toxoplasma gondii IgM FEIA

IVD Annex II List BNot specifiedOn the market

Manufacturer: Labsystems Diagnostics Oy
Manufacturer SRN: FI-MF-000018281
UDI-DI: 06438172116016
Basic UDI-DI: B-06438172116016
Reference: 6199802
EMDN: W0105050103
EMDN description: TOXOPLASMA ANTIBODY IGM
First on market country: Finland
Authorised representative: -
Last updated: 23.06.2026 11:40

Manufacturer products View details