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69 device results listed.

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COVID-19 IgG/IgM Control LQ

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: NanoEntek, Inc.
Manufacturer SRN: KR-MF-000021903
UDI-DI: 08809317540900
Basic UDI-DI: B-08809317540900
Reference: FIC-COLQ
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
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

En-swer™ COVID-19 RT-PCR Kit

En-swer™ COVID-19 RT- PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: NanoEntek, Inc.
Manufacturer SRN: KR-MF-000021903
UDI-DI: 08809317540856
Basic UDI-DI: B-08809317540856
Reference: EPCO19100
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - 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

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

Inflammation Control FD Level 1&2

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: NanoEntek, Inc.
Manufacturer SRN: KR-MF-000021903
UDI-DI: 08809317540733
Basic UDI-DI: B-08809317540733
Reference: FIC-IFFD
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
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

Influenza A&B control swab

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: NanoEntek, Inc.
Manufacturer SRN: KR-MF-000021903
UDI-DI: 08809317540726
Basic UDI-DI: B-08809317540726
Reference: FIC-FLSW
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
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 D-Dimer

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: NanoEntek, Inc.
Manufacturer SRN: KR-MF-000021903
UDI-DI: 08809317540641
Basic UDI-DI: B-08809317540641
Reference: FRDD 025
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Hungary
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 13:42

Manufacturer products Authorised representative products Authorised representative actors View details

ADAMII-CD34 Kit

ADAMII™-CD34 Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: NanoEntek, Inc.
Manufacturer SRN: KR-MF-000021903
UDI-DI: 08809317540634
Basic UDI-DI: B-08809317540634
Reference: CD34K-025
EMDN: W0103010199
EMDN description: REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - 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

08809317540610

ADAMII & ADAMII™ CD34 Kit

IVD generalIVDDOn the marketAnimal tissuesInstrumentKitProfessional testingReagent

Manufacturer: NanoEntek, Inc.
Manufacturer SRN: KR-MF-000021903
UDI-DI: 08809317540610
Basic UDI-DI: B-08809317540610
Reference: ADAM2 & CD34K-025
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
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

08809317540504

ADAM-rWBC2 & ADAM-rWBC Kit

IVD generalIVDDOn the marketInstrumentKitProfessional testingReagent

Manufacturer: NanoEntek, Inc.
Manufacturer SRN: KR-MF-000021903
UDI-DI: 08809317540504
Basic UDI-DI: B-08809317540504
Reference: ADAM-rWBC2 & ADAM-rWBC Kit
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Greece
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 PSA Plus

IVD Annex II List BIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: NanoEntek, Inc.
Manufacturer SRN: KR-MF-000021903
UDI-DI: 08809317540481
Basic UDI-DI: B-08809317540481
Reference: FRPS 025
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
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 Thyroid Duo

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: NanoEntek, Inc.
Manufacturer SRN: KR-MF-000021903
UDI-DI: 08809317540474
Basic UDI-DI: B-08809317540474
Reference: FRTDAP 020
EMDN: W01020402
EMDN description: FREE THYROXINE
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 Free T4

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: NanoEntek, Inc.
Manufacturer SRN: KR-MF-000021903
UDI-DI: 08809317540382
Basic UDI-DI: B-08809317540382
Reference: FRT4 AP 020
EMDN: W01020402
EMDN description: FREE THYROXINE
First on market country: Romania
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 Testosterone

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: NanoEntek, Inc.
Manufacturer SRN: KR-MF-000021903
UDI-DI: 08809317540375
Basic UDI-DI: B-08809317540375
Reference: FRTEAP 020
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
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 Thyroid Duo

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: NanoEntek, Inc.
Manufacturer SRN: KR-MF-000021903
UDI-DI: 08809317540368
Basic UDI-DI: B-08809317540368
Reference: FRTD 020
EMDN: W01020402
EMDN description: FREE THYROXINE
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 Vitamin D

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: NanoEntek, Inc.
Manufacturer SRN: KR-MF-000021903
UDI-DI: 08809317540337
Basic UDI-DI: B-08809317540337
Reference: FRVDAP 020
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
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

ImmunoAssay Control FD Level 1&2

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: NanoEntek, Inc.
Manufacturer SRN: KR-MF-000021903
UDI-DI: 08809317540320
Basic UDI-DI: B-08809317540320
Reference: FIC-IAFD
EMDN: W0102152008
EMDN description: CONTROLS FOR INDIVIDUAL AND SPECIFIC HORMONES
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

Cardiac Marker Control FD Level 1&2

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: NanoEntek, Inc.
Manufacturer SRN: KR-MF-000021903
UDI-DI: 08809317540283
Basic UDI-DI: B-08809317540283
Reference: FIC-CMFD
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
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