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EUDAMED Device Search

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295 device results listed.

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Malaria pf/pv Test Kit(Whole blood)

MAL0041

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Neo-nostics (Suzhou) Bioengineering Co., Ltd.
Manufacturer SRN: CN-MF-000013087
UDI-DI: 86979834610122
Basic UDI-DI: B-86979834610122
Reference: MAL0041
EMDN: W0105090499
EMDN description: PARASITES - RT & POC - OTHER
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 12.07.2026 17:22

Manufacturer products Authorised representative products Authorised representative actors View details

Schistosoma Antibody Test Kit(Serum/plasma/whole blood)

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Neo-nostics (Suzhou) Bioengineering Co., Ltd.
Manufacturer SRN: CN-MF-000013087
UDI-DI: 86979834610047
Basic UDI-DI: B-86979834610047
Reference: SEA0035
EMDN: W0105090499
EMDN description: PARASITES - RT & POC - OTHER
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 12.07.2026 17:22

Manufacturer products Authorised representative products Authorised representative actors View details

biotical Crypto Card (+PC +NC)

biotical Crypto Card (+PC +NC) / 25 test rápidos con viales para muestra fecal (+1 C. Positivo Crypto +1 C. Negativo universal)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: BIOTICAL HEALTH S.L.U
Manufacturer SRN: ES-MF-000018831
UDI-DI: 84365942153153
Basic UDI-DI: B-84365942153153
Reference: RTB25KCN
EMDN: W0105090499
EMDN description: PARASITES - RT & POC - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 10:13

Manufacturer products View details

biotical Crypto Card (+PC)

biotical Crypto Card (+PC) / 25 test rápidos con viales para muestra fecal (+1 C. Positivo Crypto)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle useSterile

Manufacturer: BIOTICAL HEALTH S.L.U
Manufacturer SRN: ES-MF-000018831
UDI-DI: 84365942153088
Basic UDI-DI: B-84365942153088
Reference: RTB25KC
EMDN: W0105090499
EMDN description: PARASITES - RT & POC - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 10:13

Manufacturer products View details

biotical Crypto Card

biotical Crypto Card / 25 test rápidos con viales para muestra fecal (sin controles externos).

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: BIOTICAL HEALTH S.L.U
Manufacturer SRN: ES-MF-000018831
UDI-DI: 84365942152920
Basic UDI-DI: B-84365942152920
Reference: RTB25K
EMDN: W0105090499
EMDN description: PARASITES - RT & POC - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 10:13

Manufacturer products View details

biotical Giardia Card (+PC +NC)

biotical Giardia Card (+PC +NC) / 25 test rápidos con viales para muestra fecal (+1 C. Positivo Giardia +1 C. Negativo universal)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: BIOTICAL HEALTH S.L.U
Manufacturer SRN: ES-MF-000018831
UDI-DI: 84365942152616
Basic UDI-DI: B-84365942152616
Reference: RTB25GCN
EMDN: W0105090499
EMDN description: PARASITES - RT & POC - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 10:12

Manufacturer products View details

biotical Giardia Card (+PC)

biotical Giardia Card (+PC) / 25 test rápidos con viales para muestra fecal (sin controles externos).

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: BIOTICAL HEALTH S.L.U
Manufacturer SRN: ES-MF-000018831
UDI-DI: 84365942152548
Basic UDI-DI: B-84365942152548
Reference: RTB25GC
EMDN: W0105090499
EMDN description: PARASITES - RT & POC - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 10:12

Manufacturer products View details

biotical Giardia Card

biotical Giardia Card /

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: BIOTICAL HEALTH S.L.U
Manufacturer SRN: ES-MF-000018831
UDI-DI: 84365942152470
Basic UDI-DI: B-84365942152470
Reference: RTB25G
EMDN: W0105090499
EMDN description: PARASITES - RT & POC - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 10:12

Manufacturer products View details

SIMPLE ENTAMOEBA / STICK ENTAMOEBA

9.143.XXX.YY.ZZZ

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: D-84295779143XYK2
Basic UDI-DI: B-84295779143XYK2
Reference: 9.143.XXX.YY.ZZZ
EMDN: W0105090499
EMDN description: PARASITES - RT & POC - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 10:09

Manufacturer products View details

SIMPLE CRYPTO-GIARDIA / STICK CRYPTO-GIARDIA

9.023.XXX.YY.ZZZ

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: D-84295779023XMHH
Basic UDI-DI: B-84295779023XMHH
Reference: 9.023.XXX.YY.ZZZ
EMDN: W0105090499
EMDN description: PARASITES - RT & POC - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 10:08

Manufacturer products View details

SIMPLE CRYPTO / STICK CRYPTO

9.022.XXX.YY.ZZZ

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: D-84295779022XKH8
Basic UDI-DI: B-84295779022XKH8
Reference: 9.022.XXX.YY.ZZZ
EMDN: W0105090499
EMDN description: PARASITES - RT & POC - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 10:08

Manufacturer products View details

SIMPLE GIARDIA / STICK GIARDIA

9.019.XXX.YY.ZZZ

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: D-84295779019XWJU
Basic UDI-DI: B-84295779019XWJU
Reference: 9.019.XXX.YY.ZZZ
EMDN: W0105090499
EMDN description: PARASITES - RT & POC - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 10:08

Manufacturer products View details

NADAL® Malaria Pf/Pan Ag 4 Species Test

NADAL Malaria Pf/Pan Ag 4 Species Test

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: nal von minden GmbH
Manufacturer SRN: DE-MF-000013321
UDI-DI: D-472038N-25AT
Basic UDI-DI: B-472038N-25AT
Reference: 472038N-25
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Germany
Authorised representative: -
Last updated: 11.07.2026 19:57

Manufacturer products View details

Cryptosporidium Antigen Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.
Manufacturer SRN: CN-MF-000013495
UDI-DI: 16972698603737
Basic UDI-DI: B-16972698603737
Reference: P221111
EMDN: W0105090499
EMDN description: PARASITES - RT & POC - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 09:52

Manufacturer products Authorised representative products Authorised representative actors View details

Filariasis IgG/IgM Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.
Manufacturer SRN: CN-MF-000013495
UDI-DI: 16972698603713
Basic UDI-DI: B-16972698603713
Reference: P231120
EMDN: W0105090499
EMDN description: PARASITES - RT & POC - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 09:52

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria Pf/Pv Antigen Rapid Test Device

P231108

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.
Manufacturer SRN: CN-MF-000013495
UDI-DI: 16972698600903
Basic UDI-DI: B-16972698600903
Reference: P231108
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 11.07.2026 09:51

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria Pf Antigen Rapid Test Device

P231107

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.
Manufacturer SRN: CN-MF-000013495
UDI-DI: 16972698600897
Basic UDI-DI: B-16972698600897
Reference: P231107
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 11.07.2026 09:51

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria Pf/Pan Antigen Rapid Test Device

P231109

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.
Manufacturer SRN: CN-MF-000013495
UDI-DI: 16972698600910
Basic UDI-DI: B-16972698600910
Reference: P231109
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 11.07.2026 09:51

Manufacturer products Authorised representative products Authorised representative actors View details

TruVue

Malaria Pf Rapid Test (LFA)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763112
Basic UDI-DI: B-15065023763112
Reference: TV10012
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 11.07.2026 08:34

Manufacturer products Authorised representative products Authorised representative actors View details

TruVue

Malaria Pf /Pv Rapid Test (LFA)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763105
Basic UDI-DI: B-15065023763105
Reference: TV10011
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Romania
Authorised representative: SUNGO Europe B.V.
Last updated: 11.07.2026 08:34

Manufacturer products Authorised representative products Authorised representative actors View details