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295 device results listed.

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Entamoeba histolytica Rapid Test

IVD generalIVDDOn the marketKitSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-IEH-ACO607TJ
Basic UDI-DI: B-IEH-ACO607TJ
Reference: IEH-ACO607
EMDN: W0105090499
EMDN description: PARASITES - RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 12.08.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

Cryptosporidium Rapid Test

IVD generalIVDDOn the marketKitSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-ICR-ACO607Y2
Basic UDI-DI: B-ICR-ACO607Y2
Reference: ICR-ACO607
EMDN: W0105090499
EMDN description: PARASITES - RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 12.08.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

Entamoeba+Giardia+Crypto Combo Rapid Test Cassette

IVD generalIVDDOn the marketKitSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-IEGC-R635(ACRO)8Q
Basic UDI-DI: B-IEGC-R635(ACRO)8Q
Reference: IEGC-R635
EMDN: W0105090499
EMDN description: PARASITES - RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 11.08.2026 23:31

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria P.f Antigen Rapid Test Cassette (WB)

IPFGi002

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-IPFGi0075
Basic UDI-DI: B-IPFGi0075
Reference: IPFGi002
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.08.2026 02:19

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria P.f/P.v Antigen Rapid Test Cassette (WB)

IFVGi21

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-IFVGi218T
Basic UDI-DI: B-IFVGi218T
Reference: IFVGi212
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.08.2026 02:19

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria P.f/Pan Antigen Rapid Test Cassette (WB)

IFPGi212, IFPGi218

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-IFPGi216R
Basic UDI-DI: B-IFPGi216R
Reference: IFPGi212, IFPGi218
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.08.2026 02:19

Manufacturer products Authorised representative products Authorised representative actors View details

Filariasis IgG/IgM Rapid Test

IFIL4212

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-IFIL421VZ
Basic UDI-DI: B-IFIL421VZ
Reference: IFIL4212
EMDN: W0105090499
EMDN description: PARASITES - RT & POC - OTHER
First on market country: Germany
Authorised representative: HUMISS TRADING S. L.
Last updated: 06.08.2026 08:11

Manufacturer products Authorised representative products Authorised representative actors View details

Scrub Typhus IgG/IgM Rapid Test

ISTA4212

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-ISTA4214R
Basic UDI-DI: B-ISTA4214R
Reference: ISTA4212
EMDN: W0105090499
EMDN description: PARASITES - RT & POC - OTHER
First on market country: Germany
Authorised representative: HUMISS TRADING S. L.
Last updated: 06.08.2026 01:36

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria Pan Antigen Rapid Test Cassette (WB)

IPANi002

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-IPANi006X
Basic UDI-DI: B-IPANi006X
Reference: IPANi002
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Germany
Authorised representative: HUMISS TRADING S. L.
Last updated: 06.08.2026 01:36

Manufacturer products Authorised representative products Authorised representative actors View details

Leishmania IgG/IgM Rapid Test

ILEI4212

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-ILEI421WE
Basic UDI-DI: B-ILEI421WE
Reference: ILEI4212
EMDN: W0105090499
EMDN description: PARASITES - RT & POC - OTHER
First on market country: Germany
Authorised representative: HUMISS TRADING S. L.
Last updated: 06.08.2026 01:36

Manufacturer products Authorised representative products Authorised representative actors View details

Filariasis Antigen Rapid Test

IFAG4002

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-IFAG400RW
Basic UDI-DI: B-IFAG400RW
Reference: IFAG4002
EMDN: W0105090499
EMDN description: PARASITES - RT & POC - OTHER
First on market country: Germany
Authorised representative: HUMISS TRADING S. L.
Last updated: 06.08.2026 01:32

Manufacturer products Authorised representative products Authorised representative actors View details

(T.V) Trichomonas Vaginalis Ag Test

Strip & Cassette

IVD generalIVDDOn the marketKitProfessional testingReagentSelf testingSingle use

Manufacturer: Abiores Technology (Beijing) Co.,Ltd.
Manufacturer SRN: CN-MF-000022952
UDI-DI: 06958982140341
Basic UDI-DI: B-06958982140341
Reference: AC50-20
EMDN: W0105090499
EMDN description: PARASITES - RT & POC - OTHER
First on market country: Belgium
Authorised representative: Sungo Cert GmbH
Last updated: 05.08.2026 14:40

Manufacturer products Authorised representative products Authorised representative actors View details

Entamoeba+Giardia+Crypto Combo Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-IEGC-ACO637SL
Basic UDI-DI: B-IEGC-ACO637SL
Reference: IEGC-ACO637
EMDN: W0105090499
EMDN description: PARASITES - RT & POC - OTHER
First on market country: Lithuania
Authorised representative: VidaQuick Biotech S.L.
Last updated: 04.08.2026 20:38

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria pf/pan Test Kit

Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000018785
UDI-DI: 06952062773108
Basic UDI-DI: B-06952062773108
Reference: MPf/Pan1W-25
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 03.08.2026 21:36

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria pf Test Kit

Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000018785
UDI-DI: 06952062772989
Basic UDI-DI: B-06952062772989
Reference: MPf1W-25
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 03.08.2026 21:36

Manufacturer products Authorised representative products Authorised representative actors View details

06941571813016

R13-116

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
Manufacturer SRN: CN-MF-000020607
UDI-DI: 06941571813016
Basic UDI-DI: B-06941571813016
Reference: R13-116
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 03.08.2026 14:49

Manufacturer products Authorised representative products Authorised representative actors View details

06941571813009

R13-110

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
Manufacturer SRN: CN-MF-000020607
UDI-DI: 06941571813009
Basic UDI-DI: B-06941571813009
Reference: R13-110
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 03.08.2026 14:49

Manufacturer products Authorised representative products Authorised representative actors View details

06941571811111

R11-116

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
Manufacturer SRN: CN-MF-000020607
UDI-DI: 06941571811111
Basic UDI-DI: B-06941571811111
Reference: R11-116
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 03.08.2026 14:49

Manufacturer products Authorised representative products Authorised representative actors View details

06941571811104

R11-110

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
Manufacturer SRN: CN-MF-000020607
UDI-DI: 06941571811104
Basic UDI-DI: B-06941571811104
Reference: R11-110
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 03.08.2026 14:49

Manufacturer products Authorised representative products Authorised representative actors View details

06941571810015

R10-116

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
Manufacturer SRN: CN-MF-000020607
UDI-DI: 06941571810015
Basic UDI-DI: B-06941571810015
Reference: R10-116
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 03.08.2026 14:48

Manufacturer products Authorised representative products Authorised representative actors View details