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495 device results listed.

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Chagas IgG/IgM Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Immuno Biotech Co., Ltd
Manufacturer SRN: CN-MF-000001118
UDI-DI: 06974238910315
Basic UDI-DI: B-06974238910315
Reference: HCHA011T
EMDN: W0105050202
EMDN description: CHAGAS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:58

Manufacturer products Authorised representative products Authorised representative actors View details

Detection Kit for Plasmodium Falciparum (PCR Fluorescence Probing)

PF001-48

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: SINGUWAY BIOTECH INC.
Manufacturer SRN: CN-MF-000027180
UDI-DI: 06974081870392
Basic UDI-DI: B-06974081870392
Reference: PF001-48
EMDN: W0105050309
EMDN description: PLASMODIUM (MALARIA) - NA REAGENTS
First on market country: France
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:51

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria (Pf/Pv) Rapid Test Kit

A02083002

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Anbio (Xiamen) Biotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000023936
UDI-DI: 06973861684235
Basic UDI-DI: B-06973861684235
Reference: A02083002
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 17:43

Manufacturer products Authorised representative products Authorised representative actors View details

06973492240374

EasyNAT Malaria Assay

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Ustar Biotechnologies (Hangzhou) Ltd.
Manufacturer SRN: CN-MF-000014615
UDI-DI: 06973492240374
Basic UDI-DI: B-06973492240374
Reference: U203010-20
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 17:19

Manufacturer products Authorised representative products Authorised representative actors View details

StrongStep® Trichomonas Vaginalis Antigen Rapid Test

20 Tests/box

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Nanjing Liming Bio-products Co. Ltd
Manufacturer SRN: CN-MF-000041298
UDI-DI: 06973181850365
Basic UDI-DI: B-06973181850365
Reference: 500040
EMDN: W0105050210
EMDN description: TRICHOMONAS
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 06.07.2026 16:52

Manufacturer products Authorised representative products Authorised representative actors View details

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

C2KJ003

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Realy Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000004716
UDI-DI: 06971792053458
Basic UDI-DI: B-06971792053458
Reference: C2KJ003
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 13:56

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria P.f./Pan Antigen Rapid Test Device

K290916D

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Realy Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000004716
UDI-DI: 06971792050464
Basic UDI-DI: B-06971792050464
Reference: K290916D
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 13:52

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria P.f./P.v. Rapid Test Device

K280916D

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Realy Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000004716
UDI-DI: 06971792050433
Basic UDI-DI: B-06971792050433
Reference: K280916D
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 13:52

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria P.f. Rapid Test Device

K270916D

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Realy Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000004716
UDI-DI: 06971792050402
Basic UDI-DI: B-06971792050402
Reference: K270916D
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 13:52

Manufacturer products Authorised representative products Authorised representative actors View details

Schistosomiasis Real Time PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SHANGHAI ZJ BIO-TECH CO., LTD
Manufacturer SRN: CN-MF-000017861
UDI-DI: 06971042229176
Basic UDI-DI: B-06971042229176
Reference: QD-0085-02
EMDN: W0105050203
EMDN description: DISTOMATOSIS
First on market country: France
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 12:03

Manufacturer products Authorised representative products Authorised representative actors View details

Plasmodium Vivax Real Time PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SHANGHAI ZJ BIO-TECH CO., LTD
Manufacturer SRN: CN-MF-000017861
UDI-DI: 06971042227455
Basic UDI-DI: B-06971042227455
Reference: ED-0217-02
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: France
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 11:58

Manufacturer products Authorised representative products Authorised representative actors View details

Plasmodium Malariae Real Time PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SHANGHAI ZJ BIO-TECH CO., LTD
Manufacturer SRN: CN-MF-000017861
UDI-DI: 06971042227448
Basic UDI-DI: B-06971042227448
Reference: ED-0216-02
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: France
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 11:58

Manufacturer products Authorised representative products Authorised representative actors View details

Plasmodium Falciparum Real Time PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SHANGHAI ZJ BIO-TECH CO., LTD
Manufacturer SRN: CN-MF-000017861
UDI-DI: 06971042227431
Basic UDI-DI: B-06971042227431
Reference: ED-0214-02
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: France
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 11:58

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria Parasite Real Time PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SHANGHAI ZJ BIO-TECH CO., LTD
Manufacturer SRN: CN-MF-000017861
UDI-DI: 06971042227400
Basic UDI-DI: B-06971042227400
Reference: ED-0066-02
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: France
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 11:58

Manufacturer products Authorised representative products Authorised representative actors View details

Cryptosporidium Real Time PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SHANGHAI ZJ BIO-TECH CO., LTD
Manufacturer SRN: CN-MF-000017861
UDI-DI: 06971042227301
Basic UDI-DI: B-06971042227301
Reference: DD-0168-02
EMDN: W0105050207
EMDN description: CRYPTOSPORIDIUM
First on market country: France
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 11:58

Manufacturer products Authorised representative products Authorised representative actors View details

Plasmodium Ovale Real Time PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SHANGHAI ZJ BIO-TECH CO., LTD
Manufacturer SRN: CN-MF-000017861
UDI-DI: 06971042225208
Basic UDI-DI: B-06971042225208
Reference: ED-0215-02
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: France
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 11:57

Manufacturer products Authorised representative products Authorised representative actors View details

Toxo IgG/IgM Rapid Test

IVD Annex II List BIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06942598205341
Basic UDI-DI: B-06942598205341
Reference: ITGM-302
EMDN: W0105050199
EMDN description: TOXOPLASMA REAGENTS - OTHER
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 06.07.2026 11:29

Manufacturer products Authorised representative products Authorised representative actors View details

04251557109418

Trichomonas vaginalis PCR kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Astra Biotech GmbH
Manufacturer SRN: DE-MF-000026439
UDI-DI: 04251557109418
Basic UDI-DI: B-04251557109418
Reference: 84-02
EMDN: W0105050310
EMDN description: TRICHOMONAS - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 07:47

Manufacturer products View details

04251557100859

Trichomonas vaginalis PCR kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Astra Biotech GmbH
Manufacturer SRN: DE-MF-000026439
UDI-DI: 04251557100859
Basic UDI-DI: B-04251557100859
Reference: 84-06
EMDN: W0105050310
EMDN description: TRICHOMONAS - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 07:46

Manufacturer products View details

04251557100842

Trichomonas vaginalis PCR kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Astra Biotech GmbH
Manufacturer SRN: DE-MF-000026439
UDI-DI: 04251557100842
Basic UDI-DI: B-04251557100842
Reference: 84-05
EMDN: W0105050310
EMDN description: TRICHOMONAS - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 07:46

Manufacturer products View details