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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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977 device results listed.

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SS-7010

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testing

Manufacturer: RevoSketch Inc.
Manufacturer SRN: KR-MF-000037550
UDI-DI: 08800122900019
Basic UDI-DI: 88001229ASS7MC
Reference: RS-ASS7-E001
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 03.07.2026 20:33

Manufacturer products Authorised representative products Authorised representative actors View details

isoQuarkF2

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testing

Manufacturer: RevoSketch Inc.
Manufacturer SRN: KR-MF-000037550
UDI-DI: 08800122900002
Basic UDI-DI: 88001229AIF2J9
Reference: RS-AIF2-E001
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 03.07.2026 20:33

Manufacturer products Authorised representative products Authorised representative actors View details

08800118510505

UF-400

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Genesystem Co., Ltd.
Manufacturer SRN: KR-MF-000022998
UDI-DI: 08800118510505
Basic UDI-DI: 88001185HS0010503U
Reference: 1599100100
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:33

Manufacturer products Authorised representative products Authorised representative actors View details

08800118510413

UF-340

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Genesystem Co., Ltd.
Manufacturer SRN: KR-MF-000022998
UDI-DI: 08800118510413
Basic UDI-DI: 88001185HS0010413T
Reference: 1499100100
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:33

Manufacturer products Authorised representative products Authorised representative actors View details

08800118510307

UF-300 / UF-300P

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Genesystem Co., Ltd.
Manufacturer SRN: KR-MF-000022998
UDI-DI: 08800118510307
Basic UDI-DI: 88001185HS0010303N
Reference: 1399100200
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:33

Manufacturer products Authorised representative products Authorised representative actors View details

08800118510208

UF-150 / UF-150E / F-150

IVD Class AIVDR 2017/746No longer on the marketDirect markingInstrumentProfessional testing

Manufacturer: Genesystem Co., Ltd.
Manufacturer SRN: KR-MF-000022998
UDI-DI: 08800118510208
Basic UDI-DI: 88001185HS0010203K
Reference: 1199100101
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:33

Manufacturer products Authorised representative products Authorised representative actors View details

STANDARD™ M10 Module

M10-01S

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111706424
Basic UDI-DI: 88001117IPAA01MA01W2
Reference: M10-01M/11M1012
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:30

Manufacturer products Authorised representative products Authorised representative actors View details

PowerEXP™ 48LH

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: KogeneBiotech Co., Ltd.
Manufacturer SRN: KR-MF-000045858
UDI-DI: 08800056348000
Basic UDI-DI: 88000563KE48005Y
Reference: KE4800
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Czechia
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 20:26

Manufacturer products Authorised representative products Authorised representative actors View details

RADIONE

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: KH Medical Co., Ltd.
Manufacturer SRN: KR-MF-000017883
UDI-DI: 08800204301871
Basic UDI-DI: 880002043POCF8
Reference: KM009
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:20

Manufacturer products Authorised representative products Authorised representative actors View details

TTÅniKoReader®

KM102

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: KH Medical Co., Ltd.
Manufacturer SRN: KR-MF-000017883
UDI-DI: 08800204301826
Basic UDI-DI: 880002043ImmunoequipFH
Reference: KM102
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:20

Manufacturer products Authorised representative products Authorised representative actors View details

ChainPro™ Real-Time Fluorescence Quantitative PCR Instrument

NGX16-4F

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsInstrumentNear-patient testingProfessional testing

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595039373
Basic UDI-DI: 868459503NGX164FYT
Reference: NGX16-4F
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 03.07.2026 18:38

Manufacturer products View details

MagFast 16-Flex Genomic DNA Purification Kit From Bacteria

MGF12P96