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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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22.09.2026 15:09

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42 device results listed.

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+ENTICANG0060DS0I

NovaLisa® Candida albicans IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTICANG0060DS0I
Basic UDI-DI: B-+ENTICANG0060DS0I
Reference: CANG0060DS
EMDN: W0105060302
EMDN description: CANDIDA ALBICANS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:09

Manufacturer products View details

+ENTICANG00600K

NovaLisa® Candida albicans IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTICANG00600K
Basic UDI-DI: B-+ENTICANG00600K
Reference: CANG0060
EMDN: W0105060302
EMDN description: CANDIDA ALBICANS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:09

Manufacturer products View details

+ENTICANA0060DS0C

NovaLisa® Candida albicans IgA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTICANA0060DS0C
Basic UDI-DI: B-+ENTICANA0060DS0C
Reference: CANA0060DS
EMDN: W0105060302
EMDN description: CANDIDA ALBICANS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:09

Manufacturer products View details

+ENTICANA00600E

NovaLisa® Candida albicans IgA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTICANA00600E
Basic UDI-DI: B-+ENTICANA00600E
Reference: CANA0060
EMDN: W0105060302
EMDN description: CANDIDA ALBICANS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:09

Manufacturer products View details

+ENTI301136190K

Candida albicans IgM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTI301136190K
Basic UDI-DI: B-+ENTI301136190K
Reference: 30113619
EMDN: W0105060302
EMDN description: CANDIDA ALBICANS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:05

Manufacturer products View details

+ENTI301136180J

Candida albicans IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTI301136180J
Basic UDI-DI: B-+ENTI301136180J
Reference: 30113618
EMDN: W0105060302
EMDN description: CANDIDA ALBICANS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:05

Manufacturer products View details

+ENTI301136170I

Candida albicans IgA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTI301136170I
Basic UDI-DI: B-+ENTI301136170I
Reference: 30113617
EMDN: W0105060302
EMDN description: CANDIDA ALBICANS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:05

Manufacturer products View details

Candida albicans Rapid Test Cassette

Candida albicans Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-ICA-R5026W
Basic UDI-DI: B-ICA-R5026W
Reference: ICA-R502
EMDN: W0105060302
EMDN description: CANDIDA ALBICANS
First on market country: Austria
Authorised representative: VidaQuick Biotech S.L.
Last updated: 14.07.2026 01:04

Manufacturer products Authorised representative products Authorised representative actors View details

Candida albicans Ag Rapid Test Kit

Candida albicans Ag Rapid Test Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: D-GKPD135XH
Basic UDI-DI: B-GKPD135XH
Reference: GKPD135
EMDN: W0105060302
EMDN description: CANDIDA ALBICANS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 14.07.2026 00:38

Manufacturer products Authorised representative products Authorised representative actors View details

Candida albicans Antigen Rapid Test Cassette (Swab)

GCCA-502a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCCA-502aHGAL
Basic UDI-DI: B-GCCA-502aHGAL
Reference: GCCA-502a
EMDN: W0105060302
EMDN description: CANDIDA ALBICANS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:23

Manufacturer products Authorised representative products Authorised representative actors View details

Candida albicans Antigen Rapid Test Cassette (Swab)

GCCA-502a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCCA-502aQC
Basic UDI-DI: B-GCCA-502aQC
Reference: GCCA-502a
EMDN: W0105060302
EMDN description: CANDIDA ALBICANS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:23

Manufacturer products Authorised representative products Authorised representative actors View details

Candida Mannan Assay (FIA)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763761
Basic UDI-DI: B-15065023763761
Reference: TV20038
EMDN: W0105060302
EMDN description: CANDIDA ALBICANS
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 11.07.2026 08:36

Manufacturer products Authorised representative products Authorised representative actors View details

Candida Mannan Lateral Flow Assay (LFA)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763358
Basic UDI-DI: B-15065023763358
Reference: TV10036
EMDN: W0105060302
EMDN description: CANDIDA ALBICANS
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 11.07.2026 08:35

Manufacturer products Authorised representative products Authorised representative actors View details

CandiDia-Antibody

CandiDia-Antibody

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: GaDia SA
Manufacturer SRN: CH-MF-000031123
UDI-DI: 07649990065021
Basic UDI-DI: B-07649990065021
Reference: CAN-025
EMDN: W0105060302
EMDN description: CANDIDA ALBICANS
First on market country: France
Authorised representative: ER Egészségügyi, Kereskedelmi és Szolgáltató Kft.
Last updated: 07.07.2026 07:02

Manufacturer products Authorised representative products Authorised representative actors View details

TECO® Fast Candida Mannan Antigen Lateral Flow Assay

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: TECOmedical AG
Manufacturer SRN: CH-MF-000030341
UDI-DI: 07640146270146
Basic UDI-DI: B-07640146270146
Reference: TE1081
EMDN: W0105060302
EMDN description: CANDIDA ALBICANS
First on market country: Germany
Authorised representative: EUROBIO SCIENTIFIC
Last updated: 07.07.2026 05:58

Manufacturer products Authorised representative products Authorised representative actors View details

Candida Albican (Ca) Ag Rapid Test

Candida Albican (Ca) Ag Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Beijing Jinwofu Bioengineering Technology Co., Ltd.
Manufacturer SRN: CN-MF-000035739
UDI-DI: 06974854620865
Basic UDI-DI: B-06974854620865
Reference: P2211125
EMDN: W0105060302
EMDN description: CANDIDA ALBICANS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:53

Manufacturer products Authorised representative products Authorised representative actors View details

Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for Candida Albicans

50 tests/kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: 06974849366204
Basic UDI-DI: B-06974849366204
Reference: HWTS-FG005A
EMDN: W0105060302
EMDN description: CANDIDA ALBICANS
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 20:51

Manufacturer products Authorised representative products Authorised representative actors View 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 products Authorised representative products Authorised representative actors View 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 products Authorised representative products Authorised representative actors View 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 products Authorised representative products Authorised representative actors View details