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EUDAMED Device Search

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TREN

Last updated

22.09.2026 11:56

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Device

3537178

Actor

47731

Certificate

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Active filter:EMDN:W01050603

149 device results listed.

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Cryptococcal Antigen Rapid Test Kit (Colloidal gold method)

CR019

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
Nanjing Synthgene Medical Technology Co., Ltd.
Manufacturer SRN
CN-MF-000023810
UDI-DI
06974473307840
Basic UDI-DI
B-06974473307840
Reference
CR019
EMDN
W0105060399
EMDN description
MYCOLOGY IMMUNOASSAYS - OTHER
First on market country
Netherlands
Authorised representative
Lotus NL B.V.
Last updated
06.07.2026 19:11
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Candida Albicans Antigen Rapid Test Kit (Colloidal gold method)

CR025

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
Nanjing Synthgene Medical Technology Co., Ltd.
Manufacturer SRN
CN-MF-000023810
UDI-DI
06974473303064
Basic UDI-DI
B-06974473303064
Reference
CR025
EMDN
W0105060302
EMDN description
CANDIDA ALBICANS
First on market country
Netherlands
Authorised representative
Lotus NL B.V.
Last updated
06.07.2026 19:10
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
StrongStep® Candida albicans antigen Rapid Test

20 Tests/box

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Nanjing Liming Bio-products Co. Ltd
Manufacturer SRN
CN-MF-000041298
UDI-DI
06973181850358
Basic UDI-DI
B-06973181850358
Reference
500030
EMDN
W0105060302
EMDN description
CANDIDA ALBICANS
First on market country
Netherlands
Authorised representative
Wellkang Ltd
Last updated
06.07.2026 16:52
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
StrongStep® Cryptococcal Antigen Rapid Test

20 Tests/box

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Nanjing Liming Bio-products Co. Ltd
Manufacturer SRN
CN-MF-000041298
UDI-DI
06973181850334
Basic UDI-DI
B-06973181850334
Reference
502080
EMDN
W0105060303
EMDN description
CRYPTOCOCCUS
First on market country
Northern Ireland
Authorised representative
Wellkang Ltd
Last updated
06.07.2026 16:52
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
PreventID® Dermatophyte

PreventID® Dermatophyte

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
Immundiagnostik AG
Manufacturer SRN
DE-MF-000020905
UDI-DI
04050598015234
Basic UDI-DI
B-04050598015234
Reference
KSTDE001GP5.03
EMDN
W0105060399
EMDN description
MYCOLOGY IMMUNOASSAYS - OTHER
First on market country
Germany
Authorised representative
-
Last updated
06.07.2026 03:50
Manufacturer productsView details
PreventID® Dermatophyte

PreventID® Dermatophyte

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
Immundiagnostik AG
Manufacturer SRN
DE-MF-000020905
UDI-DI
04050598015227
Basic UDI-DI
B-04050598015227
Reference
KSTDE001GP5.02
EMDN
W0105060399
EMDN description
MYCOLOGY IMMUNOASSAYS - OTHER
First on market country
Germany
Authorised representative
-
Last updated
06.07.2026 03:50
Manufacturer productsView details
PreventID® Dermatophyte

PreventID® Dermatophyte

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
Immundiagnostik AG
Manufacturer SRN
DE-MF-000020905
UDI-DI
04050598015210
Basic UDI-DI
B-04050598015210
Reference
KSTDE001GP5.01
EMDN
W0105060399
EMDN description
MYCOLOGY IMMUNOASSAYS - OTHER
First on market country
Germany
Authorised representative
-
Last updated
06.07.2026 03:50
Manufacturer productsView details
PreventID® Dermatophyte

PreventID® Dermatophyte

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
Immundiagnostik AG
Manufacturer SRN
DE-MF-000020905
UDI-DI
04050598015203
Basic UDI-DI
B-04050598015203
Reference
KSTDE001GP.03
EMDN
W0105060399
EMDN description
MYCOLOGY IMMUNOASSAYS - OTHER
First on market country
Germany
Authorised representative
-
Last updated
06.07.2026 03:50
Manufacturer productsView details
PreventID® Dermatophyte

PreventID® Dermatophyte

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
Immundiagnostik AG
Manufacturer SRN
DE-MF-000020905
UDI-DI
04050598015197
Basic UDI-DI
B-04050598015197
Reference
KSTDE001GP.01
EMDN
W0105060399
EMDN description
MYCOLOGY IMMUNOASSAYS - OTHER
First on market country
Germany
Authorised representative
-
Last updated
06.07.2026 03:50
Manufacturer productsView details
PreventID® Dermatophyte

PreventID® Dermatophyte

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
Immundiagnostik AG
Manufacturer SRN
DE-MF-000020905
UDI-DI
04050598010314
Basic UDI-DI
B-04050598010314
Reference
KSTDE001GP.02
EMDN
W0105060399
EMDN description
MYCOLOGY IMMUNOASSAYS - OTHER
First on market country
Germany
Authorised representative
-
Last updated
06.07.2026 03:48
Manufacturer productsView details
PreventID® Dermatophyte

PreventID® Dermatophyte

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
Immundiagnostik AG
Manufacturer SRN
DE-MF-000020905
UDI-DI
04050598010284
Basic UDI-DI
B-04050598010284
Reference
KSTDE001GP
EMDN
W0105060399
EMDN description
MYCOLOGY IMMUNOASSAYS - OTHER
First on market country
Germany
Authorised representative
-
Last updated
06.07.2026 03:48
Manufacturer productsView details
BIOSYNEX CryptoPS

BIOSYNEX CryptoPS

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
Manufacturer
BIOSYNEX
Manufacturer SRN
FR-MF-000014073
UDI-DI
03532679917565
Basic UDI-DI
353267F00074P8G
Reference
1120001-50
EMDN
W0105060303
EMDN description
CRYPTOCOCCUS
First on market country
France
Authorised representative
-
Last updated
01.07.2026 12:27
Manufacturer productsView details
β-Glucan Test R1: Pretreatment Solution

-

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagentSingle use
Manufacturer
FUJIFILM Wako Pure Chemical Corporation
Manufacturer SRN
JP-MF-000013944
UDI-DI
14987481163802
Basic UDI-DI
498748114987481163802ZB
Reference
993-04201
EMDN
W0105060304
EMDN description
MYCOLOGY CONTROLS - INF.IMM.
First on market country
-
Authorised representative
FUJIFILM Wako Chemicals Europe GmbH
Last updated
01.07.2026 10:36
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
06970514081151

Mucorales Molecular Detection Kit (Real-time PCR)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
Genobio Pharmaceutical Co., Ltd.
Manufacturer SRN
CN-MF-000027997
UDI-DI
06970514081151
Basic UDI-DI
B-06970514081151
Reference
FMPCR-50
EMDN
W0105060399
EMDN description
MYCOLOGY IMMUNOASSAYS - OTHER
First on market country
Germany
Authorised representative
Caretechion GmbH
Last updated
30.06.2026 04:08
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
06970514081144

Mucorales Molecular Detection Kit (Real-time PCR)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
Genobio Pharmaceutical Co., Ltd.
Manufacturer SRN
CN-MF-000027997
UDI-DI
06970514081144
Basic UDI-DI
B-06970514081144
Reference
FMPCR-20
EMDN
W0105060399
EMDN description
MYCOLOGY IMMUNOASSAYS - OTHER
First on market country
Germany
Authorised representative
Caretechion GmbH
Last updated
30.06.2026 04:08
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
06970514080673

Cryptococcal Capsular Polysaccharide Detection Kit (CLIA)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
Genobio Pharmaceutical Co., Ltd.
Manufacturer SRN
CN-MF-000027997
UDI-DI
06970514080673
Basic UDI-DI
B-06970514080673
Reference
GXMCLIA-01
EMDN
W0105060303
EMDN description
CRYPTOCOCCUS
First on market country
Germany
Authorised representative
Caretechion GmbH
Last updated
30.06.2026 04:07
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Candida Mannan IgM Antibody Detection K-Set(CLIA)

CMCLIA-01

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
Genobio Pharmaceutical Co., Ltd.
Manufacturer SRN
CN-MF-000027997
UDI-DI
06970514080666
Basic UDI-DI
B-06970514080666
Reference
CMCLIA-01
EMDN
W0105060302
EMDN description
CANDIDA ALBICANS
First on market country
Germany
Authorised representative
Caretechion GmbH
Last updated
30.06.2026 04:07
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
06970514080659

Candida IgG Antibody Detection Kit (CLIA)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
Genobio Pharmaceutical Co., Ltd.
Manufacturer SRN
CN-MF-000027997
UDI-DI
06970514080659
Basic UDI-DI
B-06970514080659
Reference
CGCLIA-01
EMDN
W0105060302
EMDN description
CANDIDA ALBICANS
First on market country
Germany
Authorised representative
Caretechion GmbH
Last updated
30.06.2026 04:07
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
06970514080642

Candida Mannan Detection Kit (CLIA)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
Genobio Pharmaceutical Co., Ltd.
Manufacturer SRN
CN-MF-000027997
UDI-DI
06970514080642
Basic UDI-DI
B-06970514080642
Reference
MNCLIA-01
EMDN
W0105060302
EMDN description
CANDIDA ALBICANS
First on market country
Germany
Authorised representative
Caretechion GmbH
Last updated
30.06.2026 04:07
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Aspergillus IgM Antibody Detection K-Set(CLIA)

Aspergillus IgM Antibody Detection Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
Genobio Pharmaceutical Co., Ltd.
Manufacturer SRN
CN-MF-000027997
UDI-DI
06970514080635
Basic UDI-DI
B-06970514080635
Reference
AMCLIA-01
EMDN
W0105060301
EMDN description
ASPERGILLUS
First on market country
Germany
Authorised representative
Caretechion GmbH
Last updated
30.06.2026 04:07
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details