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191 device results listed.

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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

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 products Authorised representative products Authorised representative actors View details

Pneumocystis jirovecii Real Time PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SHANGHAI ZJ BIO-TECH CO., LTD
Manufacturer SRN: CN-MF-000017861
UDI-DI: 06971042229169
Basic UDI-DI: B-06971042229169
Reference: QD-0082-02
EMDN: W0105060499
EMDN description: MYCOLOGY NA REAGENTS - OTHER
First on market country: France
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 12:03

Manufacturer products Authorised representative products Authorised representative actors View details

Fungus Real Time PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SHANGHAI ZJ BIO-TECH CO., LTD
Manufacturer SRN: CN-MF-000017861
UDI-DI: 06971042228995
Basic UDI-DI: B-06971042228995
Reference: FD-0330-02
EMDN: W0105060499
EMDN description: MYCOLOGY NA REAGENTS - OTHER
First on market country: France
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 12:03

Manufacturer products Authorised representative products Authorised representative actors View details

Candida Albicans Real Time PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SHANGHAI ZJ BIO-TECH CO., LTD
Manufacturer SRN: CN-MF-000017861
UDI-DI: 06971042228988
Basic UDI-DI: B-06971042228988
Reference: FD-0329-02
EMDN: W0105060402
EMDN description: CANDIDA ALBICANS - NA REAGENTS
First on market country: France
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 12:03

Manufacturer products Authorised representative products Authorised representative actors View details

Cryptococcus Neoformans Real Time PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SHANGHAI ZJ BIO-TECH CO., LTD
Manufacturer SRN: CN-MF-000017861
UDI-DI: 06971042225161
Basic UDI-DI: B-06971042225161
Reference: FD-0328-02
EMDN: W0105060499
EMDN description: MYCOLOGY NA REAGENTS - OTHER
First on market country: France
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 11:56

Manufacturer products Authorised representative products Authorised representative actors View details

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

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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

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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 products View details

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

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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 products View details

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 products View details

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 products View details

DermaGenius® 2.0 Complete Multiplex real-time PCR kit

PN-401

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagentSingle use

Manufacturer: PathoNostics B.V.
Manufacturer SRN: NL-MF-000002705
UDI-DI: 08719326750934
Basic UDI-DI: 87193267509PN-401EQ
Reference: PN-401
EMDN: W0105060402
EMDN description: CANDIDA ALBICANS - NA REAGENTS
First on market country: Netherlands
Authorised representative: -
Last updated: 03.07.2026 19:35

Manufacturer products View details

PNEUMOCYSTIS JIROVECII REALTIME PCR KIT

RTPCR027

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436610290180
Basic UDI-DI: 843661029RTPCR027018Y
Reference: RTPCR027-LP
EMDN: W0105060499
EMDN description: MYCOLOGY NA REAGENTS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 14:57

Manufacturer products View details

03770041419099

60318

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: ADEMTECH
Manufacturer SRN: FR-MF-000048678
UDI-DI: 03770041419099
Basic UDI-DI: 377004141960318CK
Reference: 60318
EMDN: W0105060405
EMDN description: PNEUMOCYSTIS - NA REAGENTS
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 16:16

Manufacturer products View details

03770041419044

60307

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: ADEMTECH
Manufacturer SRN: FR-MF-000048678
UDI-DI: 03770041419044
Basic UDI-DI: 377004141960307CE
Reference: 60307
EMDN: W0105060405
EMDN description: PNEUMOCYSTIS - NA REAGENTS
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 16:16

Manufacturer products View details

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 products View 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 products Authorised representative products Authorised representative actors View details