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289 device results listed.

Page 11 / 15

Plasmodium Falciparum/Plasmodium Vivax Antigen Rapid Test Cassette (Colloidal Gold Method)

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06974323013730
Basic UDI-DI: B-06974323013730
Reference: IH012
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 18:56

Manufacturer products Authorised representative products Authorised representative actors View details

Real-Time PCR Detection Kit for Universal Plasmodium Falciparum

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06974323011163
Basic UDI-DI: B-06974323011163
Reference: A3751
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 18:46

Manufacturer products Authorised representative products Authorised representative actors View details

Real-Time PCR Detection Kit for Universal Plasmodium Falciparum

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06974323011156
Basic UDI-DI: B-06974323011156
Reference: A3751
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 18:46

Manufacturer products Authorised representative products Authorised representative actors View details

Real-time PCR Detection Kit for Plasmodium Vivax

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06974323011040
Basic UDI-DI: B-06974323011040
Reference: ID048
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 18:44

Manufacturer products Authorised representative products Authorised representative actors View details

Real-time PCR Detection Kit for Plasmodium Vivax

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06974323011033
Basic UDI-DI: B-06974323011033
Reference: ID048
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 18:44

Manufacturer products Authorised representative products Authorised representative actors View details

Real-time PCR Detection Kit for Plasmodium Ovale

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06974323011026
Basic UDI-DI: B-06974323011026
Reference: ID047
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 18:44

Manufacturer products Authorised representative products Authorised representative actors View details

Real-time PCR Detection Kit for Plasmodium Ovale

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06974323011019
Basic UDI-DI: B-06974323011019
Reference: ID047
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 18:44

Manufacturer products Authorised representative products Authorised representative actors View details

Real-time PCR Detection Kit for Plasmodium Malariae

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06974323011002
Basic UDI-DI: B-06974323011002
Reference: ID046
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 18:44

Manufacturer products Authorised representative products Authorised representative actors View details

Real-time PCR Detection Kit for Plasmodium Malariae

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06974323010999
Basic UDI-DI: B-06974323010999
Reference: ID046
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 18:44

Manufacturer products Authorised representative products Authorised representative actors View details

Leishmania IgG/IgM Rapid Test

Leishmania IgG/IgM Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Immuno Biotech Co., Ltd
Manufacturer SRN: CN-MF-000001118
UDI-DI: 06974238911152
Basic UDI-DI: B-06974238911152
Reference: HLSH003T
EMDN: W0105050205
EMDN description: LEISHMANIA
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:59

Manufacturer products Authorised representative products Authorised representative actors View details

Giardia Lamblia Antigen Rapid Test

Giardia Lamblia Antigen Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Immuno Biotech Co., Ltd
Manufacturer SRN: CN-MF-000001118
UDI-DI: 06974238911138
Basic UDI-DI: B-06974238911138
Reference: HGIA030G
EMDN: W0105050208
EMDN description: GIARDIA LAMBLIA
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:59

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria P.f./Pan Antigen Rapid Test

Malaria P.f./Pan Antigen Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Immuno Biotech Co., Ltd
Manufacturer SRN: CN-MF-000001118
UDI-DI: 06974238910322
Basic UDI-DI: B-06974238910322
Reference: HMAL013G
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
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

Chagas IgG/IgM Rapid Test

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

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

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