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289 device results listed.

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

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IMPV-402Q2
Basic UDI-DI: B-IMPV-402Q2
Reference: IMPV-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

Malaria P.f./Pan Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IMPN-402MA
Basic UDI-DI: B-IMPN-402MA
Reference: IMPN-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

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

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

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