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57 device results listed.

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Logix Smart ABC (Influenza A/B, SARS-Cov-2)

ABC-K-001

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: Co-Diagnostics, Inc.
Manufacturer SRN: US-MF-000036425
UDI-DI: D-ABC-K-001H5
Basic UDI-DI: B-ABC-K-001H5
Reference: ABC-K-001
EMDN: W0105070502
EMDN description: OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS
First on market country: Lithuania
Authorised representative: mdi Europa GmbH
Last updated: 12.07.2026 21:17

Manufacturer products Authorised representative products Authorised representative actors View details

D-81649002CRTI701ASJHB

CRTI701A-AHG4E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Life Science LLC
Manufacturer SRN: US-MF-000043017
UDI-DI: D-81649002CRTI701ASJHB
Basic UDI-DI: B-81649002CRTI701ASJHB
Reference: CRTI701A-AHG4E
EMDN: W0105070502
EMDN description: OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 10:05

Manufacturer products Authorised representative products Authorised representative actors View details

D-81649002CRTI601ASBGE

CRTI601A-AHG4E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Life Science LLC
Manufacturer SRN: US-MF-000043017
UDI-DI: D-81649002CRTI601ASBGE
Basic UDI-DI: B-81649002CRTI601ASBGE
Reference: CRTI601A-AHG4E
EMDN: W0105070502
EMDN description: OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 10:05

Manufacturer products Authorised representative products Authorised representative actors View details

D-81649002CFFCR01AJ45L

CFFCR01A-AHG4E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Life Science LLC
Manufacturer SRN: US-MF-000043017
UDI-DI: D-81649002CFFCR01AJ45L
Basic UDI-DI: B-81649002CFFCR01AJ45L
Reference: CFFCR01A-AHG4E
EMDN: W0105070502
EMDN description: OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details

TruDerma

Dermatophyte PCR Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065026245349
Basic UDI-DI: B-15065026245349
Reference: TM10002
EMDN: W0105070502
EMDN description: OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 11.07.2026 08:38

Manufacturer products Authorised representative products Authorised representative actors View details

RIDA®Plex Staphylococcus and VRE 8 well Step 2

RIDA®Plex Staphylococcus and VRE 8 well

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044006470
Basic UDI-DI: B-09343044006470
Reference: 21340P
EMDN: W0105070502
EMDN description: OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: R-Biopharm AG
Last updated: 10.07.2026 23:44

Manufacturer products Authorised representative products Authorised representative actors View details

RIDA®Plex Staphylococcus and VRE 8 well Step 1

RIDA®Plex Staphylococcus and VRE 8 well

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044006487
Basic UDI-DI: B-09343044006487
Reference: 21340S
EMDN: W0105070502
EMDN description: OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: R-Biopharm AG
Last updated: 10.07.2026 23:44

Manufacturer products Authorised representative products Authorised representative actors View details

Staphylococcus + VRE 8-well

Step 1 tubes for Staphylococcus + VRE 8-well

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044002038
Basic UDI-DI: B-09343044002038
Reference: 21340S
EMDN: W0105070502
EMDN description: OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS
First on market country: Malta
Authorised representative: Advena Limited
Last updated: 10.07.2026 23:42

Manufacturer products Authorised representative products Authorised representative actors View details

Staphylococcus + VRE 8-well

Step 2 Plates for Staphylococcus + VRE 8-well

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044002021
Basic UDI-DI: B-09343044002021
Reference: 21340P
EMDN: W0105070502
EMDN description: OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS
First on market country: Malta
Authorised representative: Advena Limited
Last updated: 10.07.2026 23:42

Manufacturer products Authorised representative products Authorised representative actors View details

Allplex™ Genital ulcer Assay

IVD Annex II List BIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240101773
Basic UDI-DI: B-08809240101773
Reference: SD10177Z
EMDN: W0105070502
EMDN description: OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 12:44

Manufacturer products Authorised representative products Authorised representative actors View details

Allplex™ Genital ulcer Assay

IVD Annex II List BIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240100714
Basic UDI-DI: B-08809240100714
Reference: SD9802X
EMDN: W0105070502
EMDN description: OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 12:43

Manufacturer products Authorised representative products Authorised representative actors View details

Allplex™ Genital ulcer Assay

IVD Annex II List BIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240100707
Basic UDI-DI: B-08809240100707
Reference: SD9802Y
EMDN: W0105070502
EMDN description: OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 12:43

Manufacturer products Authorised representative products Authorised representative actors View details

Allplex™ Candidiasis Assay

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240005576
Basic UDI-DI: B-08809240005576
Reference: SD9803Y
EMDN: W0105070502
EMDN description: OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

RevoDx Urinary Tract Infections (UTIs) Pathogen Detection Kit