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614 device results listed.

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Malaria P.f. Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IMA-402PE
Basic UDI-DI: B-IMA-402PE
Reference: IMA-402
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 24.07.2026 00:41

Manufacturer products Authorised representative products Authorised representative actors View details

Leishmania IgG/IgM Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-ILEI-402EK
Basic UDI-DI: B-ILEI-402EK
Reference: ILEI-402
EMDN: W0105050205
EMDN description: LEISHMANIA
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 24.07.2026 00:41

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria P.f./P.v. /Pan Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-FI-MAL-435QF
Basic UDI-DI: B-FI-MAL-435QF
Reference: FI-MAL-435
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 24.07.2026 00:41

Manufacturer products Authorised representative products Authorised representative actors View details

LIAISON® XL Toxo IgG Avidity

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: DiaSorin Italia S.p.A.
Manufacturer SRN: IT-MF-000029422
UDI-DI: 08056771100953
Basic UDI-DI: 805677131079556
Reference: 310795
EMDN: W0105050104
EMDN description: TOXOPLASMA ANTIBODY IGG - AVIDITY
First on market country: Italy
Authorised representative: -
Last updated: 23.07.2026 01:39

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LIAISON® Toxo IgG II

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: DiaSorin Italia S.p.A.
Manufacturer SRN: IT-MF-000029422
UDI-DI: 08056771100939
Basic UDI-DI: 80567713107804R
Reference: 310780
EMDN: W0105050102
EMDN description: TOXOPLASMA ANTIBODY IGG
First on market country: Italy
Authorised representative: -
Last updated: 23.07.2026 01:39

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Chagas Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-ICHA-40289
Basic UDI-DI: B-ICHA-40289
Reference: ICHA-402
EMDN: W0105050202
EMDN description: CHAGAS
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 22.07.2026 06:37

Manufacturer products Authorised representative products Authorised representative actors View details

Chagas Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-ICHA-30284
Basic UDI-DI: B-ICHA-30284
Reference: ICHA-302
EMDN: W0105050202
EMDN description: CHAGAS
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 22.07.2026 06:37

Manufacturer products Authorised representative products Authorised representative actors View details

Giardia Lamblia Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IGL-602R3
Basic UDI-DI: B-IGL-602R3
Reference: IGL-602
EMDN: W0105050208
EMDN description: GIARDIA LAMBLIA
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 21.07.2026 07:30

Manufacturer products Authorised representative products Authorised representative actors View details

Entamoeba histolytica Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IEH-602NV
Basic UDI-DI: B-IEH-602NV
Reference: IEH-602
EMDN: W0105050201
EMDN description: ENTAMOEBA HISTOLYTICA
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 21.07.2026 07:30

Manufacturer products Authorised representative products Authorised representative actors View details

Cryptosporidium Antigen Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-ICR-602RH
Basic UDI-DI: B-ICR-602RH
Reference: ICR-602
EMDN: W0105050207
EMDN description: CRYPTOSPORIDIUM
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 21.07.2026 07:29

Manufacturer products Authorised representative products Authorised representative actors View details

Loopamp™ Malaria Pan Detection Kit

IVD Class CNot specifiedOn the marketProfessional testingReagent

Manufacturer: EIKEN CHEMICAL CO., LTD.
Manufacturer SRN: JP-MF-000018097
UDI-DI: 04033145206705
Basic UDI-DI: 4987026TD-LFMPZM
Reference: 977000
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: -
Authorised representative: Human Gesellschaft für Biochemica und Diagnostica mbH
Last updated: 18.07.2026 09:26

Manufacturer products Authorised representative products Authorised representative actors View details

Toxo IgG/IgM Rapid Test Cassette

IVD Annex II List BIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-ITGM-402LZ
Basic UDI-DI: B-ITGM-402LZ
Reference: ITGM-402
EMDN: W0105050101
EMDN description: TOXOPLASMA ANTIBODY (TOTAL)
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 17.07.2026 23:41

Manufacturer products Authorised representative products Authorised representative actors View details

Toxo IgG/IgM Rapid Test Cassette

IVD Annex II List BIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-ITGM-302LU
Basic UDI-DI: B-ITGM-302LU
Reference: ITGM-302
EMDN: W0105050101
EMDN description: TOXOPLASMA ANTIBODY (TOTAL)
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 17.07.2026 23:41

Manufacturer products Authorised representative products Authorised representative actors View details

VIASURE Dientamoeba fragilis Real Time PCR Detection Kit

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440219187
Basic UDI-DI: 84354402_MDXGASTROB_DIEQ2
Reference: VS-DIE101L
EMDN: W0105050399
EMDN description: OTHER PARASITOLOGY - NA REAGENTS
First on market country: Spain
Authorised representative: -
Last updated: 17.07.2026 22:55

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Trichomonas Ag Rapid Test Cassette (Swab)

GCTV-502a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCTV-502aOG42
Basic UDI-DI: B-GCTV-502aOG42
Reference: GCTV-502a
EMDN: W0105050210
EMDN description: TRICHOMONAS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 07:02

Manufacturer products Authorised representative products Authorised representative actors View details

08054320950103

IDS TOXO Avidity Control Set

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Technogenetics S.p.A
Manufacturer SRN: IT-MF-000025331
UDI-DI: 08054320950103
Basic UDI-DI: 805432095ISID5130M2
Reference: IS-ID5130
EMDN: W0105050104
EMDN description: TOXOPLASMA ANTIBODY IGG - AVIDITY
First on market country: Italy
Authorised representative: -
Last updated: 17.07.2026 05:43

Manufacturer products View details

08054320950035

IDS TOXO IgG Avidity

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Technogenetics S.p.A
Manufacturer SRN: IT-MF-000025331
UDI-DI: 08054320950035
Basic UDI-DI: 805432095ISID5101LT
Reference: IS-ID5101
EMDN: W0105050104
EMDN description: TOXOPLASMA ANTIBODY IGG - AVIDITY
First on market country: Italy
Authorised representative: -
Last updated: 17.07.2026 05:43

Manufacturer products View details

08054320950028

IDS TOXO IgM

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Technogenetics S.p.A
Manufacturer SRN: IT-MF-000025331
UDI-DI: 08054320950028
Basic UDI-DI: 805432095ISID5002LQ
Reference: IS-ID5002
EMDN: W0105050103
EMDN description: TOXOPLASMA ANTIBODY IGM
First on market country: Italy
Authorised representative: -
Last updated: 17.07.2026 05:42

Manufacturer products View details

08054320950011

IDS TOXO IgG

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Technogenetics S.p.A
Manufacturer SRN: IT-MF-000025331
UDI-DI: 08054320950011
Basic UDI-DI: 805432095ISID5001LN
Reference: IS-ID5001
EMDN: W0105050102
EMDN description: TOXOPLASMA ANTIBODY IGG
First on market country: Italy
Authorised representative: -
Last updated: 17.07.2026 05:42

Manufacturer products View details

Trichomonas Vaginalis Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-ITV-R502QG
Basic UDI-DI: B-ITV-R502QG
Reference: ITV-R502
EMDN: W0105050210
EMDN description: TRICHOMONAS
First on market country: Austria
Authorised representative: VidaQuick Biotech S.L.
Last updated: 17.07.2026 05:05

Manufacturer products Authorised representative products Authorised representative actors View details