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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

ELISA-VIDITEST anti-Toxoplasma gondii IgG and IgG avidity

IVD Annex II List BIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: VIDIA spol. s r.o.
Manufacturer SRN: CZ-MF-000036964
UDI-DI: 28594036044825
Basic UDI-DI: B-28594036044825
Reference: ODZ-482
EMDN: W0105050104
EMDN description: TOXOPLASMA ANTIBODY IGG - AVIDITY
First on market country: Czechia
Authorised representative: -
Last updated: 11.07.2026 16:22

Manufacturer products View details

ELISA-VIDITEST anti-Toxoplasma gondii IgG

IVD Annex II List BIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: VIDIA spol. s r.o.
Manufacturer SRN: CZ-MF-000036964
UDI-DI: 28594036044818
Basic UDI-DI: B-28594036044818
Reference: ODZ-481
EMDN: W0105050102
EMDN description: TOXOPLASMA ANTIBODY IGG
First on market country: Czechia
Authorised representative: -
Last updated: 11.07.2026 16:22

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ELISA-VIDITEST anti-Toxoplasma gondii IgA

IVD Annex II List BIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: VIDIA spol. s r.o.
Manufacturer SRN: CZ-MF-000036964
UDI-DI: 28594036044801
Basic UDI-DI: B-28594036044801
Reference: ODZ-480
EMDN: W0105050199
EMDN description: TOXOPLASMA REAGENTS - OTHER
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

iFlash-Toxo IgG

IVD Class CNot specifiedOn the market

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912724018
Basic UDI-DI: 692591270101GQ
Reference: C88029G-S
EMDN: W0105050104
EMDN description: TOXOPLASMA ANTIBODY IGG - AVIDITY
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 IgG avidita

IVD Annex II List BIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: VIDIA spol. s r.o.
Manufacturer SRN: CZ-MF-000036964
UDI-DI: 18594036042138
Basic UDI-DI: B-18594036042138
Reference: K-213-12
EMDN: W0105050104
EMDN description: TOXOPLASMA ANTIBODY IGG - AVIDITY
First on market country: Czechia
Authorised representative: -
Last updated: 11.07.2026 10:25

Manufacturer products View details

MONO-VIDITEST anti-Toxoplasma gondii IgA

IVD Annex II List BIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: VIDIA spol. s r.o.
Manufacturer SRN: CZ-MF-000036964
UDI-DI: 18594036042121
Basic UDI-DI: B-18594036042121
Reference: K-212-12
EMDN: W0105050199
EMDN description: TOXOPLASMA REAGENTS - OTHER
First on market country: Czechia
Authorised representative: -
Last updated: 11.07.2026 10:25

Manufacturer products 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

Manufacturer products View details

MONO-VIDITEST anti-Toxoplasma gondii IgG

IVD Annex II List BIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: VIDIA spol. s r.o.
Manufacturer SRN: CZ-MF-000036964
UDI-DI: 18594036042107
Basic UDI-DI: B-18594036042107
Reference: K-210-12
EMDN: W0105050102
EMDN description: TOXOPLASMA ANTIBODY IGG
First on market country: Czechia
Authorised representative: -
Last updated: 11.07.2026 10:25

Manufacturer products View details

14560189216065

CL AIA-PACK Toxo IgG ADJUSTER SET

IVD Annex II List BIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 14560189216065
Basic UDI-DI: B-14560189216065
Reference: 0029259
EMDN: W0105050102
EMDN description: TOXOPLASMA ANTIBODY IGG
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 11.07.2026 08:03

Manufacturer products Authorised representative products Authorised representative actors View details

14560189215983

CL AIA-PACK Toxo IgG TEST CUP

IVD Annex II List BIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 14560189215983
Basic UDI-DI: B-14560189215983
Reference: 0029159
EMDN: W0105050102
EMDN description: TOXOPLASMA ANTIBODY IGG
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 11.07.2026 08:03

Manufacturer products Authorised representative products Authorised representative actors View details

Truenat® Malaria Pv/Pf

601010025

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Molbio Diagnostics Limited
Manufacturer SRN: IN-MF-000028386
UDI-DI: 08908020139019
Basic UDI-DI: B-08908020139019
Reference: 601010025
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 10.07.2026 21:30

Manufacturer products Authorised representative products Authorised representative actors View details

Truenat Malaria Pv/Pf

601010050

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Molbio Diagnostics Limited
Manufacturer SRN: IN-MF-000028386
UDI-DI: 08908007989330
Basic UDI-DI: B-08908007989330
Reference: 601010050
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 10.07.2026 21:26

Manufacturer products Authorised representative products Authorised representative actors View details

Truenat Malaria Pv/Pf

601010020

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingSingle use

Manufacturer: Molbio Diagnostics Limited
Manufacturer SRN: IN-MF-000028386
UDI-DI: 08908007989323
Basic UDI-DI: B-08908007989323
Reference: 601010020
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 10.07.2026 21:26

Manufacturer products Authorised representative products Authorised representative actors View details

Truenat® Malaria Pv/Pf

601010005

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Molbio Diagnostics Limited
Manufacturer SRN: IN-MF-000028386
UDI-DI: 08908007989316
Basic UDI-DI: B-08908007989316
Reference: 601010005, 601010020,601010025, 601010050
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 10.07.2026 21:26

Manufacturer products Authorised representative products Authorised representative actors View details

08885019710193

300222

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: AITbiotech Pte Ltd
Manufacturer SRN: SG-MF-000003510
UDI-DI: 08885019710193
Basic UDI-DI: B-08885019710193
Reference: 300222
EMDN: W0105050309
EMDN description: PLASMODIUM (MALARIA) - NA REAGENTS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 10.07.2026 17:20

Manufacturer products Authorised representative products Authorised representative actors View details

08885019710186

300221

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: AITbiotech Pte Ltd
Manufacturer SRN: SG-MF-000003510
UDI-DI: 08885019710186
Basic UDI-DI: B-08885019710186
Reference: 300221
EMDN: W0105050309
EMDN description: PLASMODIUM (MALARIA) - NA REAGENTS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 10.07.2026 17:20

Manufacturer products Authorised representative products Authorised representative actors View details