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191 device results listed.

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LyoSens™

Aspergillus qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684998275354
Basic UDI-DI: 868499827PCR96YG
Reference: LYO96WS24
EMDN: W0105060401
EMDN description: ASPERGILLUS - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 31.07.2026 23:29

Manufacturer products View details

LyoSens™

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684998275392
Basic UDI-DI: 868499827PCR96YG
Reference: LYO96WS48
EMDN: W0105060401
EMDN description: ASPERGILLUS - NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 31.07.2026 22:55

Manufacturer products View details

LyoSens™

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684998275439
Basic UDI-DI: 868499827PCR96YG
Reference: LYO96WS96
EMDN: W0105060401
EMDN description: ASPERGILLUS - NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 31.07.2026 22:55

Manufacturer products View details

ChainFor™

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684998276191
Basic UDI-DI: 868499827PCR96YG
Reference: CFP96P25
EMDN: W0105060401
EMDN description: ASPERGILLUS - NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 31.07.2026 22:55

Manufacturer products View details

ChainFor™

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684998276207
Basic UDI-DI: 868499827PCR96YG
Reference: CFP96P50
EMDN: W0105060401
EMDN description: ASPERGILLUS - NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 31.07.2026 22:55

Manufacturer products View details

ChainFor™

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684998276214
Basic UDI-DI: 868499827PCR96YG
Reference: CFP96P100
EMDN: W0105060401
EMDN description: ASPERGILLUS - NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 31.07.2026 22:55

Manufacturer products View details

ASPERGILLUS GALACTOMANNAN AG VIRCLIA® MONOTEST

VCM073

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436040327555
Basic UDI-DI: 843604032VCM07301D5
Reference: VCM073
EMDN: W0105060301
EMDN description: ASPERGILLUS
First on market country: Spain
Authorised representative: -
Last updated: 31.07.2026 22:49

Manufacturer products View details

Aspergillus fumigatus IgG ELISA

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: Bordier Affinity Products SA
Manufacturer SRN: CH-MF-000025247
UDI-DI: 07640158216101
Basic UDI-DI: 7640158216100ZC
Reference: 6100
EMDN: W0105060301
EMDN description: ASPERGILLUS
First on market country: France
Authorised representative: Leman Diagnostics SARL
Last updated: 31.07.2026 22:04

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: 04050598015388
Basic UDI-DI: B-04050598015388
Reference: KSTDE001GP.06
EMDN: W0105060399
EMDN description: MYCOLOGY IMMUNOASSAYS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 15:25

Manufacturer products View details

PreventID® Dermatophyte

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598015395
Basic UDI-DI: B-04050598015395
Reference: KSTDE001GP5.06
EMDN: W0105060399
EMDN description: MYCOLOGY IMMUNOASSAYS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 15:25

Manufacturer products View details

PreventID® Dermatophyte

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598016620
Basic UDI-DI: B-04050598016620
Reference: KSTDE001GP.09
EMDN: W0105060399
EMDN description: MYCOLOGY IMMUNOASSAYS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 15:25

Manufacturer products View details

PreventID® Dermatophyte

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598016637
Basic UDI-DI: B-04050598016637
Reference: KSTDE001GP5.09
EMDN: W0105060399
EMDN description: MYCOLOGY IMMUNOASSAYS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 15:25

Manufacturer products View details

04250592378544

eazyplex® Candida auris

IVD Class CIVDR 2017/746On the marketKitProfessional testingSingle use

Manufacturer: AmplexDiagnostics GmbH
Manufacturer SRN: DE-MF-000014117
UDI-DI: 04250592378544
Basic UDI-DI: 42505923CAURJW
Reference: 7854
EMDN: W0105060404
EMDN description: CANDIDA AURIS - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 00:42

Manufacturer products View details

04250592376267

eazyplex® Pneumocystis jirovecii

IVD Class CIVDR 2017/746On the marketKitProfessional testingSingle use

Manufacturer: AmplexDiagnostics GmbH
Manufacturer SRN: DE-MF-000014117
UDI-DI: 04250592376267
Basic UDI-DI: 425059237626A3
Reference: 7626
EMDN: W0105060405
EMDN description: PNEUMOCYSTIS - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 00:42

Manufacturer products View details

Cryptococcus Antigen Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-ICRG-402ED
Basic UDI-DI: B-ICRG-402ED
Reference: ICRG-402
EMDN: W0105060303
EMDN description: CRYPTOCOCCUS
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 27.07.2026 06:36

Manufacturer products Authorised representative products Authorised representative actors View details

Rightsign

ICTG-C41

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: HangZhou Biotest Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000008191
UDI-DI: D-ICTG-C41HP
Basic UDI-DI: B-ICTG-C41HP
Reference: ICTG-C41
EMDN: W0105060303
EMDN description: CRYPTOCOCCUS
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 05:03

Manufacturer products Authorised representative products Authorised representative actors View details

D-697994388Nc045ZVEN

Pneumocystis jirovecii Nucleic Acid Detection Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Kangsheng Information Technology (Hangzhou) Co. LTD
Manufacturer SRN: CN-MF-000053775
UDI-DI: D-697994388Nc045ZVEN
Basic UDI-DI: B-697994388Nc045ZVEN
Reference: Nc045
EMDN: W0105060405
EMDN description: PNEUMOCYSTIS - NA REAGENTS
First on market country: Germany
Authorised representative: Crealkraft GmbH
Last updated: 17.07.2026 04:28

Manufacturer products Authorised representative products Authorised representative actors View details

D-697994388Nc044ZTED

Cryptococcus Nucleic Acid Detection Kit (CSF)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Kangsheng Information Technology (Hangzhou) Co. LTD
Manufacturer SRN: CN-MF-000053775
UDI-DI: D-697994388Nc044ZTED
Basic UDI-DI: B-697994388Nc044ZTED
Reference: Nc044
EMDN: W0105060403
EMDN description: CRYPTOCOCCUS - NA REAGENTS
First on market country: Germany
Authorised representative: Crealkraft GmbH
Last updated: 17.07.2026 04:28

Manufacturer products Authorised representative products Authorised representative actors View details

D-697994388Nc043ZRE4

Aspergillus Nucleic Acid Detection Kit (Sputum/BALF)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Kangsheng Information Technology (Hangzhou) Co. LTD
Manufacturer SRN: CN-MF-000053775
UDI-DI: D-697994388Nc043ZRE4
Basic UDI-DI: B-697994388Nc043ZRE4
Reference: Nc043
EMDN: W0105060401
EMDN description: ASPERGILLUS - NA REAGENTS
First on market country: Germany
Authorised representative: Crealkraft GmbH
Last updated: 17.07.2026 04:28

Manufacturer products Authorised representative products Authorised representative actors View details

D-697994388Fa045WP8X

Pneumocystis jirovecii Nucleic Acid Detection Kit (Fluorescence, BALF)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Kangsheng Information Technology (Hangzhou) Co. LTD
Manufacturer SRN: CN-MF-000053775
UDI-DI: D-697994388Fa045WP8X
Basic UDI-DI: B-697994388Fa045WP8X
Reference: Fa045
EMDN: W0105060405
EMDN description: PNEUMOCYSTIS - NA REAGENTS
First on market country: Germany
Authorised representative: Crealkraft GmbH
Last updated: 17.07.2026 04:23

Manufacturer products Authorised representative products Authorised representative actors View details