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308 device results listed.

Page 10 / 16

LyoSens Giardia lamblia Detection qPCR Kit

LYO20

IVD generalIVDDOn the marketCompanion diagnosticsInstrumentKitNear-patient testingProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548258748
Basic UDI-DI: B-08683548258748
Reference: LYO20
EMDN: W0105050208
EMDN description: GIARDIA LAMBLIA
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 00:19

Manufacturer products View details

LyoSens Entamoeba histolytica Detection qPCR Kit

LYO19

IVD generalIVDDOn the marketCompanion diagnosticsInstrumentKitNear-patient testingProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548258731
Basic UDI-DI: B-08683548258731
Reference: LYO19
EMDN: W0105050201
EMDN description: ENTAMOEBA HISTOLYTICA
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 00:19

Manufacturer products View details

LyoSens Cryptosporidium Detection qPCR Kit

LYO18

IVD generalIVDDOn the marketCompanion diagnosticsInstrumentKitNear-patient testingProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548258724
Basic UDI-DI: B-08683548258724
Reference: LYO18
EMDN: W0105050207
EMDN description: CRYPTOSPORIDIUM
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 00:19

Manufacturer products View details

ChainFor™ Cryptosporidium + Giardia + E. Histolytica Detection qPCR Kit

CFP59

IVD generalIVDDOn the marketCompanion diagnosticsInstrumentKitNear-patient testingProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548257604
Basic UDI-DI: B-08683548257604
Reference: CFP59
EMDN: W0105050201
EMDN description: ENTAMOEBA HISTOLYTICA
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 00:16

Manufacturer products View details

ChainFor Giardia lamblia Detection qPCR Kit

CFP47

IVD generalIVDDOn the marketCompanion diagnosticsInstrumentKitNear-patient testingProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548257499
Basic UDI-DI: B-08683548257499
Reference: CFP47
EMDN: W0105050208
EMDN description: GIARDIA LAMBLIA
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 00:16

Manufacturer products View details

ChainFor Entamoeba histolytica Detection qPCR Kit

CFP46

IVD generalIVDDOn the marketCompanion diagnosticsInstrumentKitNear-patient testingProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548257482
Basic UDI-DI: B-08683548257482
Reference: CFP46
EMDN: W0105050201
EMDN description: ENTAMOEBA HISTOLYTICA
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 00:16

Manufacturer products View details

ChainFor Cryptosporidium Detection qPCR Kit

CFP45

IVD generalIVDDOn the marketCompanion diagnosticsInstrumentKitNear-patient testingProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548257475
Basic UDI-DI: B-08683548257475
Reference: CFP45
EMDN: W0105050207
EMDN description: CRYPTOSPORIDIUM
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 00:16

Manufacturer products View details

Chagatest ELISA lisado

Chagatest ELISA lisado

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Wiener Laboratorios SAIC
Manufacturer SRN: AR-MF-000023605
UDI-DI: 07798100046839
Basic UDI-DI: B-07798100046839
Reference: 1293096
EMDN: W0105050202
EMDN description: CHAGAS
First on market country: Netherlands
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 07.07.2026 07:11

Manufacturer products Authorised representative products Authorised representative actors View details

Chagatest ELISA recombinante v.4.0

Chagatest ELISA recombinante v.4.0

IVD generalIVDDNo longer on the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Wiener Laboratorios SAIC
Manufacturer SRN: AR-MF-000023605
UDI-DI: 07798100047720
Basic UDI-DI: B-07798100047720
Reference: 1293258
EMDN: W0105050202
EMDN description: CHAGAS
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 07.07.2026 07:11

Manufacturer products Authorised representative products Authorised representative actors View details

Chagatest ELISA lisado

Chagatest ELISA lisado

IVD generalIVDDNo longer on the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Wiener Laboratorios SAIC
Manufacturer SRN: AR-MF-000023605
UDI-DI: 07798100046815
Basic UDI-DI: B-07798100046815
Reference: 1293192
EMDN: W0105050202
EMDN description: CHAGAS
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 07.07.2026 07:11

Manufacturer products Authorised representative products Authorised representative actors View details

Chagatest ELISA recombinante v.4.0

Chagatest ELISA recombinante v.4.0

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Wiener Laboratorios SAIC
Manufacturer SRN: AR-MF-000023605
UDI-DI: 07798100044170
Basic UDI-DI: B-07798100044170
Reference: 1293257
EMDN: W0105050202
EMDN description: CHAGAS
First on market country: Netherlands
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 07.07.2026 07:11

Manufacturer products Authorised representative products Authorised representative actors View details

SchistoDia Antibody

SCH-025

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: GaDia SA
Manufacturer SRN: CH-MF-000031123
UDI-DI: 07649990065090
Basic UDI-DI: B-07649990065090
Reference: SCH-025
EMDN: W0105050206
EMDN description: SCHISTOSOMA
First on market country: Poland
Authorised representative: ER Egészségügyi, Kereskedelmi és Szolgáltató Kft.
Last updated: 07.07.2026 07:03

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria Pf/Pan Antigen Rapid Test Cassette(Colloidal Gold)

1T/BOX,10T/BOX,20T/BOX,25T/BOX,40T/BOX,50T/BOX

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: 06977698401744
Basic UDI-DI: B-06977698401744
Reference: GKPD034
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 07.07.2026 01:28

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria Pf Antigen Rapid Test Cassette(Colloidal Gold)

1T/BOX,10T/BOX,20T/BOX,25T/BOX,40T/BOX,50T/BOX

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: 06977698401683
Basic UDI-DI: B-06977698401683
Reference: GKPD033
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 07.07.2026 01:28

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria Ag P.f (HRP-Ⅱ) Assay Reagent Kit (CMIA)

C2KC003

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Cybereagen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000037850
UDI-DI: 06976753477588
Basic UDI-DI: B-06976753477588
Reference: C2KC003
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 01:01

Manufacturer products Authorised representative products Authorised representative actors View details

Serum Amyloid A (SAA) Assay Reagent Kit (CMIA)

C2KC002

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Cybereagen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000037850
UDI-DI: 06976753477540
Basic UDI-DI: B-06976753477540
Reference: C2KC002
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 01:01

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria P.fP.v Rapid Test Device (whole blood)

A290901D

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Cybereagen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000037850
UDI-DI: 06976753474600
Basic UDI-DI: B-06976753474600
Reference: A290901D
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 00:59

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria P.f.Pan Antigen Rapid Test Device (whole blood)

A280901D

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Cybereagen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000037850
UDI-DI: 06976753474570
Basic UDI-DI: B-06976753474570
Reference: A280901D
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 00:59

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria P.f. Rapid Test Device (whole blood)

A270901D

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Cybereagen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000037850
UDI-DI: 06976753474549
Basic UDI-DI: B-06976753474549
Reference: A270901D
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 00:59

Manufacturer products Authorised representative products Authorised representative actors View details

Giardia Lamblia Rapid Test

GIGIL

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Greylynx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032462
UDI-DI: 06976202763118
Basic UDI-DI: B-06976202763118
Reference: GIGIL-602
EMDN: W0105050208
EMDN description: GIARDIA LAMBLIA
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 07.07.2026 00:39

Manufacturer products Authorised representative products Authorised representative actors View details