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TREN

Last updated

02.08.2026 18:51

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Device

2993259

Actor

47526

Certificate

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Active filter:EMDN:W010505

496 device results listed.

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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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView details
Schistosomiasis Real Time PCR Kit

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 productsAuthorised representative productsAuthorised representative actorsView details
Plasmodium Vivax Real Time PCR Kit

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 productsAuthorised representative productsAuthorised representative actorsView details
Plasmodium Malariae Real Time PCR Kit

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 productsAuthorised representative productsAuthorised representative actorsView details
Plasmodium Falciparum Real Time PCR Kit

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 productsAuthorised representative productsAuthorised representative actorsView details
Malaria Parasite Real Time PCR Kit

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 productsAuthorised representative productsAuthorised representative actorsView details
Cryptosporidium Real Time PCR Kit

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 productsAuthorised representative productsAuthorised representative actorsView details
Plasmodium Ovale Real Time PCR Kit

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 productsAuthorised representative productsAuthorised representative actorsView details
Toxo IgG/IgM Rapid Test

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 productsAuthorised representative productsAuthorised representative actorsView 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 productsView 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 productsView details