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EUDAMED Device Search

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FREND™ COVID-19 Ag+FLU A&B

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: NanoEntek, Inc.
Manufacturer SRN: KR-MF-000021903
UDI-DI: 08809317541013
Basic UDI-DI: B-08809317541013
Reference: FRCGFL 020
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 13:43

Manufacturer products Authorised representative products Authorised representative actors View details

FREND™ COVID-19 SP

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: NanoEntek, Inc.
Manufacturer SRN: KR-MF-000021903
UDI-DI: 08809317540931
Basic UDI-DI: B-08809317540931
Reference: FRCOS 020
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 13:42

Manufacturer products Authorised representative products Authorised representative actors View details

FREND™ COVID-19 total Ab

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: NanoEntek, Inc.
Manufacturer SRN: KR-MF-000021903
UDI-DI: 08809317540924
Basic UDI-DI: B-08809317540924
Reference: FRCOA 020
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 13:42

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 total Ab Control LQ

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: NanoEntek, Inc.
Manufacturer SRN: KR-MF-000021903
UDI-DI: 08809317540917
Basic UDI-DI: B-08809317540917
Reference: FIC-COALQ
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 13:42

Manufacturer products Authorised representative products Authorised representative actors View details

FREND FLU A&B

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: NanoEntek, Inc.
Manufacturer SRN: KR-MF-000021903
UDI-DI: 08809317540863
Basic UDI-DI: B-08809317540863
Reference: FRFL 020
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 13:42

Manufacturer products Authorised representative products Authorised representative actors View details

FREND™ COVID-19 IgG/IgM Duo

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: NanoEntek, Inc.
Manufacturer SRN: KR-MF-000021903
UDI-DI: 08809317540832
Basic UDI-DI: B-08809317540832
Reference: FRCOD 020
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 13:42

Manufacturer products Authorised representative products Authorised representative actors View details

BioTracer™ Influenza A&B Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: NanoEntek, Inc.
Manufacturer SRN: KR-MF-000021903
UDI-DI: 08809317540818
Basic UDI-DI: B-08809317540818
Reference: 11321
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 13:42

Manufacturer products Authorised representative products Authorised representative actors View details

BioTracer™ Influenza A&B Rapid Card

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: NanoEntek, Inc.
Manufacturer SRN: KR-MF-000021903
UDI-DI: 08809317540801
Basic UDI-DI: B-08809317540801
Reference: 11311
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 13:42

Manufacturer products Authorised representative products Authorised representative actors View details

08800069141018

ACROSIS COVID-19 Ag (NPS)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: SG BioScience Inc.
Manufacturer SRN: KR-MF-000009362
UDI-DI: 08800069141018
Basic UDI-DI: B-08800069141018
Reference: R4101
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 05:13

Manufacturer products Authorised representative products Authorised representative actors View details

08800069130074

InstaView COVID-19 Antigen Home Test

IVD self-testing devicesIVDDOn the marketKitReagentSelf testingSingle use

Manufacturer: SG BioScience Inc.
Manufacturer SRN: KR-MF-000009362
UDI-DI: 08800069130074
Basic UDI-DI: B-08800069130074
Reference: R3007
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 05:13

Manufacturer products Authorised representative products Authorised representative actors View details

08800069130067

InstaView COVID-19 Antigen

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle useSterile

Manufacturer: SG BioScience Inc.
Manufacturer SRN: KR-MF-000009362
UDI-DI: 08800069130067
Basic UDI-DI: B-08800069130067
Reference: R3006
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 05:13

Manufacturer products Authorised representative products Authorised representative actors View details

08800069130029

InstaView COVID-19 Antigen

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: SG BioScience Inc.
Manufacturer SRN: KR-MF-000009362
UDI-DI: 08800069130029
Basic UDI-DI: B-08800069130029
Reference: R3002
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 05:12

Manufacturer products Authorised representative products Authorised representative actors View details

08693285187652

Rotavirus Test