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Active filter:Manufacturer SRN:KR-MF-000048224

8 device results listed.

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Respiratory Pathogens Multiplex Detection Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hysen Biotech.Inc
Manufacturer SRN: KR-MF-000048224
UDI-DI: D-MUR-24E3W
Basic UDI-DI: B-MUR-24E3W
Reference: MUR-24E
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 17.07.2026 05:09

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Meningitis/Encephalitis (ME) Pathogens Multiplex Detection Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hysen Biotech.Inc
Manufacturer SRN: KR-MF-000048224
UDI-DI: D-MME-14ETX
Basic UDI-DI: B-MME-14ETX
Reference: MME-14E
EMDN: W0105070505
EMDN description: MENINGITIS / ENCEPHALITIS INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 17.07.2026 05:09

Manufacturer products Authorised representative products Authorised representative actors View details

Lower Respiratory Pathogens Multiplex Detection Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hysen Biotech.Inc
Manufacturer SRN: KR-MF-000048224
UDI-DI: D-MLR-19EYG
Basic UDI-DI: B-MLR-19EYG
Reference: MLR-19E
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 17.07.2026 05:09

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Influenza A+B Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hysen Biotech.Inc
Manufacturer SRN: KR-MF-000048224
UDI-DI: D-HIFL-522E6
Basic UDI-DI: B-HIFL-522E6
Reference: HIFL-522
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Czechia
Authorised representative: Medunion S.L.
Last updated: 17.07.2026 05:03

Manufacturer products Authorised representative products Authorised representative actors View details

Blood Pathogens and Drug Resistance Genes Digital PCR Detection Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hysen Biotech.Inc
Manufacturer SRN: KR-MF-000048224
UDI-DI: D-DBP01UK
Basic UDI-DI: B-DBP01UK
Reference: DBP01
EMDN: W0105070502
EMDN description: OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 17.07.2026 04:58

Manufacturer products Authorised representative products Authorised representative actors View details

Auto-Pure 10B

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hysen Biotech.Inc
Manufacturer SRN: KR-MF-000048224
UDI-DI: 08809975891208
Basic UDI-DI: 88099758902007000488
Reference: Auto-Pure 10B
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 16.07.2026 12:51

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HysenD30H

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hysen Biotech.Inc
Manufacturer SRN: KR-MF-000048224
UDI-DI: 08809975891017
Basic UDI-DI: 88099758902007000284
Reference: HysenD30H
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 16.07.2026 12:51

Manufacturer products Authorised representative products Authorised representative actors View details

HysenDx 200

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hysen Biotech.Inc
Manufacturer SRN: KR-MF-000048224
UDI-DI: 08809975890034
Basic UDI-DI: 88099758902007000182
Reference: HysenDx 200
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 16.07.2026 12:51

Manufacturer products Authorised representative products Authorised representative actors View details