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308 device results listed.

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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

01220000260191

NATtrol™ Chlamydia trachomatis Positive Control Pack

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testing

Manufacturer: ZeptoMetrix LLC
Manufacturer SRN: US-MF-000035245
UDI-DI: 01220000260191
Basic UDI-DI: 122000026NATERCK5
Reference: NATTVNEG-6MC-IVD
EMDN: W0105050211
EMDN description: TRICHOMONAS - NA REAGENTS
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 17.07.2026 08:08

Manufacturer products Authorised representative products Authorised representative actors View details

01220000260184

NATtrol™ Chlamydia trachomatis Positive Control Pack

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testing

Manufacturer: ZeptoMetrix LLC
Manufacturer SRN: US-MF-000035245
UDI-DI: 01220000260184
Basic UDI-DI: 122000026NATERCK5
Reference: NATTVPOS-6MC-IVD
EMDN: W0105050211
EMDN description: TRICHOMONAS - NA REAGENTS
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 17.07.2026 08:03

Manufacturer products Authorised representative products Authorised representative actors View details

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

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

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

+ENTISCHM04100.

NovaLisa® Schistosoma mansoni IgM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTISCHM04100.
Basic UDI-DI: B-+ENTISCHM04100.
Reference: SCHM0410
EMDN: W0105050206
EMDN description: SCHISTOSOMA
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:19

Manufacturer products View details

+ENTIRE589010H

Malaria

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIRE589010H
Basic UDI-DI: B-+ENTIRE589010H
Reference: RE58901
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:19

Manufacturer products View details

+ENTIRE587010F

Ascaris lumbricoides IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIRE587010F
Basic UDI-DI: B-+ENTIRE587010F
Reference: RE58701
EMDN: W0105050299
EMDN description: PARASITOLOGY - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:19

Manufacturer products View details

+ENTIRE586910N

Chagas (Trypanosoma cruzi) IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIRE586910N
Basic UDI-DI: B-+ENTIRE586910N
Reference: RE58691
EMDN: W0105050202
EMDN description: CHAGAS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:19

Manufacturer products View details

+ENTIRE586410I

Leishmania infantum IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIRE586410I
Basic UDI-DI: B-+ENTIRE586410I
Reference: RE58641
EMDN: W0105050205
EMDN description: LEISHMANIA
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:19

Manufacturer products View details

+ENTIRE586310H

Entamoeba histolytica IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIRE586310H
Basic UDI-DI: B-+ENTIRE586310H
Reference: RE58631
EMDN: W0105050201
EMDN description: ENTAMOEBA HISTOLYTICA
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:19

Manufacturer products View details

+ENTIMAL0620DS0C

NovaLisa® Malaria

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIMAL0620DS0C
Basic UDI-DI: B-+ENTIMAL0620DS0C
Reference: MAL0620DS
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:15

Manufacturer products View details

+ENTIMAL06200E

NovaLisa® Malaria

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIMAL06200E
Basic UDI-DI: B-+ENTIMAL06200E
Reference: MAL0620
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:15

Manufacturer products View details

+ENTILEIG0310DS0O

NovaLisa® Leishmania infantum IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTILEIG0310DS0O
Basic UDI-DI: B-+ENTILEIG0310DS0O
Reference: LEIG0310DS
EMDN: W0105050205
EMDN description: LEISHMANIA
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:15

Manufacturer products View details

+ENTILEIG03100Q

NovaLisa® Leishmania infantum IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTILEIG03100Q
Basic UDI-DI: B-+ENTILEIG03100Q
Reference: LEIG0310
EMDN: W0105050205
EMDN description: LEISHMANIA
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:15

Manufacturer products View details