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609 device results listed.

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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

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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

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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

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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

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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

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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

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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

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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

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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

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D-EIM4411116FN

TOXO IgG Antibody Chemiluminescent Immunoassay Kit

IVD Annex II List BIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4411116FN
Basic UDI-DI: B-EIM4411116FN
Reference: EIM4411116
EMDN: W0105050102
EMDN description: TOXOPLASMA ANTIBODY IGG
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 05:00

Manufacturer products Authorised representative products Authorised representative actors View details

D-697994388Fa016WG7V

Plasmodium Nucleic Acid Detection Kit (Fluorescence)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Kangsheng Information Technology (Hangzhou) Co. LTD
Manufacturer SRN: CN-MF-000053775
UDI-DI: D-697994388Fa016WG7V
Basic UDI-DI: B-697994388Fa016WG7V
Reference: Fa016
EMDN: W0105050309
EMDN description: PLASMODIUM (MALARIA) - NA REAGENTS
First on market country: Germany
Authorised representative: Crealkraft GmbH
Last updated: 17.07.2026 04:19

Manufacturer products Authorised representative products Authorised representative actors View details

Candida Albicans/Gardnerella Vaginalis /Trichomonas Vaginalis Combo Rapid Test（Swab）

Cryptosporidium Antigen Rapid Test（Fecal swab）

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Zhejiang Anji Saianfu Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045029
UDI-DI: 69743840312782
Basic UDI-DI: B-69743840312782
Reference: 3025601
EMDN: W0105050207
EMDN description: CRYPTOSPORIDIUM
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 17.07.2026 04:13

Manufacturer products Authorised representative products Authorised representative actors View details

Giardia antigen Rapid Test

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Zhejiang Anji Saianfu Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045029
UDI-DI: 69743840310702
Basic UDI-DI: B-69743840310702
Reference: 3023701
EMDN: W0105050208
EMDN description: GIARDIA LAMBLIA
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 17.07.2026 04:12

Manufacturer products Authorised representative products Authorised representative actors View details

Leishmania IgG IgM Rapid Test

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Zhejiang Anji Saianfu Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045029
UDI-DI: 69743840310320
Basic UDI-DI: B-69743840310320
Reference: 3023301
EMDN: W0105050205
EMDN description: LEISHMANIA
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 17.07.2026 04:12

Manufacturer products Authorised representative products Authorised representative actors View details

Toxo IgG/IgM Rapid Test

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Zhejiang Anji Saianfu Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045029
UDI-DI: 69743840304626
Basic UDI-DI: B-69743840304626
Reference: 3022601
EMDN: W0105050199
EMDN description: TOXOPLASMA REAGENTS - OTHER
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 17.07.2026 04:11

Manufacturer products Authorised representative products Authorised representative actors View details

Xpert®

Xpert® TV

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Cepheid
Manufacturer SRN: US-MF-000010979
UDI-DI: 07332940001018
Basic UDI-DI: B-07332940001018
Reference: GXTV-CE-10
EMDN: W0105050310
EMDN description: TRICHOMONAS - NA REAGENTS
First on market country: Netherlands
Authorised representative: Cepheid AB
Last updated: 16.07.2026 19:55

Manufacturer products Authorised representative products Authorised representative actors View details