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ChainFor Cryptosporidium Detection qPCR Kit

CFP45

IVD generalIVDDOn the marketCompanion diagnosticsInstrumentKitNear-patient testingProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548257475
Basic UDI-DI: B-08683548257475
Reference: CFP45
EMDN: W0105050207
EMDN description: CRYPTOSPORIDIUM
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 00:16

Manufacturer products View details

Toxo IgG CLIA Microparticles

IVD Class CNot specifiedOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359552011
Basic UDI-DI: 697015090000104GV
Reference: CMK0605
EMDN: W0105050102
EMDN description: TOXOPLASMA ANTIBODY IGG
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

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

TaqPath™ Menu | GeneProof™ Trichomonas vaginalis PCR Kit

GeneProof Trichomonas vaginalis PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08595696304041
Basic UDI-DI: B-08595696304041
Reference: A58126
EMDN: W0105050310
EMDN description: TRICHOMONAS - NA REAGENTS
First on market country: Czechia
Authorised representative: -
Last updated: 08.07.2026 01:59

Manufacturer products View details

GeneProof Trichomonas vaginalis MC PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08595696300968
Basic UDI-DI: B-08595696300968
Reference: TV/MC/190
EMDN: W0105050310
EMDN description: TRICHOMONAS - NA REAGENTS
First on market country: Czechia
Authorised representative: -
Last updated: 08.07.2026 01:58

Manufacturer products View details

GeneProof Trichomonas vaginalis MC PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08595696300944
Basic UDI-DI: B-08595696300944
Reference: TV/MC/038
EMDN: W0105050310
EMDN description: TRICHOMONAS - NA REAGENTS
First on market country: Czechia
Authorised representative: -
Last updated: 08.07.2026 01:58

Manufacturer products 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

ELISA-VIDITEST anti-Toxoplasma gondii IgG a avidita 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: 08594036044821
Basic UDI-DI: B-08594036044821
Reference: OD-482
EMDN: W0105050104
EMDN description: TOXOPLASMA ANTIBODY IGG - AVIDITY
First on market country: Czechia
Authorised representative: -
Last updated: 08.07.2026 01:45

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: 08594036044814
Basic UDI-DI: B-08594036044814
Reference: OD-481
EMDN: W0105050102
EMDN description: TOXOPLASMA ANTIBODY IGG
First on market country: Czechia
Authorised representative: -
Last updated: 08.07.2026 01:45

Manufacturer products View details

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: 08594036044807
Basic UDI-DI: B-08594036044807
Reference: OD-480
EMDN: W0105050199
EMDN description: TOXOPLASMA REAGENTS - OTHER
First on market country: Czechia
Authorised representative: -
Last updated: 08.07.2026 01:45

Manufacturer products View details

quanty TOXO (RH Region)

RT-94

IVD Annex II List BIVDDOn the marketKitProfessional testingReagent

Manufacturer: Clonit srl
Manufacturer SRN: IT-MF-000022196
UDI-DI: 08057680910275
Basic UDI-DI: B-08057680910275
Reference: RT-94
EMDN: W0105050105
EMDN description: TOXOPLASMA - NA REAGENTS
First on market country: Italy
Authorised representative: -
Last updated: 07.07.2026 21:33

Manufacturer products View details

Chagatest ELISA lisado

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Wiener Laboratorios SAIC
Manufacturer SRN: AR-MF-000023605
UDI-DI: 07798100046839
Basic UDI-DI: B-07798100046839
Reference: 1293096
EMDN: W0105050202
EMDN description: CHAGAS
First on market country: Netherlands
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 07.07.2026 07:11

Manufacturer products Authorised representative products Authorised representative actors View details

Chagatest ELISA recombinante v.4.0

IVD generalIVDDNo longer on the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Wiener Laboratorios SAIC
Manufacturer SRN: AR-MF-000023605
UDI-DI: 07798100047720
Basic UDI-DI: B-07798100047720
Reference: 1293258
EMDN: W0105050202
EMDN description: CHAGAS
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 07.07.2026 07:11

Manufacturer products Authorised representative products Authorised representative actors View details

Chagatest ELISA lisado

IVD generalIVDDNo longer on the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Wiener Laboratorios SAIC
Manufacturer SRN: AR-MF-000023605
UDI-DI: 07798100046815
Basic UDI-DI: B-07798100046815
Reference: 1293192
EMDN: W0105050202
EMDN description: CHAGAS
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 07.07.2026 07:11

Manufacturer products Authorised representative products Authorised representative actors View details

Chagatest ELISA recombinante v.4.0

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Wiener Laboratorios SAIC
Manufacturer SRN: AR-MF-000023605
UDI-DI: 07798100044170
Basic UDI-DI: B-07798100044170
Reference: 1293257
EMDN: W0105050202
EMDN description: CHAGAS
First on market country: Netherlands
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 07.07.2026 07:11

Manufacturer products Authorised representative products Authorised representative actors View details

SchistoDia Antibody

SCH-025

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: GaDia SA
Manufacturer SRN: CH-MF-000031123
UDI-DI: 07649990065090
Basic UDI-DI: B-07649990065090
Reference: SCH-025
EMDN: W0105050206
EMDN description: SCHISTOSOMA
First on market country: Poland
Authorised representative: ER Egészségügyi, Kereskedelmi és Szolgáltató Kft.
Last updated: 07.07.2026 07:03

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria Pf/Pan Antigen Rapid Test Cassette(Colloidal Gold)

1T/BOX,10T/BOX,20T/BOX,25T/BOX,40T/BOX,50T/BOX

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: 06977698401744
Basic UDI-DI: B-06977698401744
Reference: GKPD034
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 07.07.2026 01:28

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria Pf Antigen Rapid Test Cassette(Colloidal Gold)

1T/BOX,10T/BOX,20T/BOX,25T/BOX,40T/BOX,50T/BOX

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: 06977698401683
Basic UDI-DI: B-06977698401683
Reference: GKPD033
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 07.07.2026 01:28

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria Ag P.f (HRP-Ⅱ) Assay Reagent Kit (CMIA)

C2KC003

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Cybereagen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000037850
UDI-DI: 06976753477588
Basic UDI-DI: B-06976753477588
Reference: C2KC003
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 01:01

Manufacturer products Authorised representative products Authorised representative actors View details

Serum Amyloid A (SAA) Assay Reagent Kit (CMIA)

C2KC002

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Cybereagen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000037850
UDI-DI: 06976753477540
Basic UDI-DI: B-06976753477540
Reference: C2KC002
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 01:01

Manufacturer products Authorised representative products Authorised representative actors View details