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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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RIDA®Xtract 24

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IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044006166
Basic UDI-DI: 93430440W02050106U2
Reference: 96420
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: -
Authorised representative: R-Biopharm AG
Last updated: 21.06.2026 17:34

Manufacturer products Authorised representative products Authorised representative actors View details

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IVD Class AIVDR 2017/746On the marketDirect markingInstrument

Manufacturer: Bio-Molecular Systems Pty Ltd
Manufacturer SRN: AU-MF-000025328
UDI-DI: 09369999312930
Basic UDI-DI: 93577950MicIVDG7
Reference: MIC-IVD
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: -
Authorised representative: mdi Europa GmbH
Last updated: 21.06.2026 17:33

Manufacturer products Authorised representative products Authorised representative actors View details

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IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: KH Medical Co., Ltd.
Manufacturer SRN: KR-MF-000017883
UDI-DI: 08800204300027
Basic UDI-DI: 88002043RADIPREPSD
Reference: OE006
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 20.06.2026 23:04

Manufacturer products Authorised representative products Authorised representative actors View details

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IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: KH Medical Co., Ltd.
Manufacturer SRN: KR-MF-000017883
UDI-DI: 08800204300034
Basic UDI-DI: 88002043RADIPREPSD
Reference: OP002
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 20.06.2026 23:04

Manufacturer products Authorised representative products Authorised representative actors View details

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IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: KH Medical Co., Ltd.
Manufacturer SRN: KR-MF-000017883
UDI-DI: 08800204300089
Basic UDI-DI: 88002043RADIPREPSD
Reference: MP002
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 20.06.2026 23:04

Manufacturer products Authorised representative products Authorised representative actors View details

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IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: KH Medical Co., Ltd.
Manufacturer SRN: KR-MF-000017883
UDI-DI: 08800204300102
Basic UDI-DI: 88002043RADIPREPSD
Reference: KM003
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 20.06.2026 23:04

Manufacturer products Authorised representative products Authorised representative actors View details

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IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: KH Medical Co., Ltd.
Manufacturer SRN: KR-MF-000017883
UDI-DI: 08800204300133
Basic UDI-DI: 88002043RADIPREPSD
Reference: OE005
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 20.06.2026 23:04

Manufacturer products Authorised representative products Authorised representative actors View details

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IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: KH Medical Co., Ltd.
Manufacturer SRN: KR-MF-000017883
UDI-DI: 08800204300300
Basic UDI-DI: 88002043RADIPREPSD
Reference: AP006
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 20.06.2026 23:04

Manufacturer products Authorised representative products Authorised representative actors View details

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IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: KH Medical Co., Ltd.
Manufacturer SRN: KR-MF-000017883
UDI-DI: 08800204300348
Basic UDI-DI: 88002043RADIPREPSD
Reference: FP001
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 20.06.2026 23:04

Manufacturer products Authorised representative products Authorised representative actors View details

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IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: KH Medical Co., Ltd.
Manufacturer SRN: KR-MF-000017883
UDI-DI: 08800204300355
Basic UDI-DI: 88002043RADIPREPSD
Reference: FP002
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 20.06.2026 23:04

Manufacturer products Authorised representative products Authorised representative actors View details

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IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: KH Medical Co., Ltd.
Manufacturer SRN: KR-MF-000017883
UDI-DI: 08800204300706
Basic UDI-DI: 88002043RADIPREPSD
Reference: OP001
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 20.06.2026 23:04

Manufacturer products Authorised representative products Authorised representative actors View details

STANDARD™ M10 Console

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IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111710032
Basic UDI-DI: 88001117IPAA01MA01W2
Reference: M10-01C/11M1011
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: 20.06.2026 20:04

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer: Genesystem Co., Ltd.
Manufacturer SRN: KR-MF-000022998
UDI-DI: 08800118510215
Basic UDI-DI: 88001185HS0010203K
Reference: 1199100300
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: 20.06.2026 20:04

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer: Genesystem Co., Ltd.
Manufacturer SRN: KR-MF-000022998
UDI-DI: 08800118510222
Basic UDI-DI: 88001185HS0010203K
Reference: 1199100400
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: 20.06.2026 20:04

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer: Genesystem Co., Ltd.
Manufacturer SRN: KR-MF-000022998
UDI-DI: 08800118510321
Basic UDI-DI: 88001185HS0010303N
Reference: 1399100300
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: 20.06.2026 20:04

Manufacturer products Authorised representative products Authorised representative actors View details

EntericBio® Viral Panel 2 plug-in

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IVD generalNot specifiedOn the market

Manufacturer: Serosep Limited
Manufacturer SRN: IE-MF-000020322
UDI-DI: 05391513879623
Basic UDI-DI: B-05391513879623
Reference: EBFFS - VP2
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Ireland
Authorised representative: -
Last updated: 20.06.2026 05:34

Manufacturer products View details

EntericBio® Viral Panel 1 plug-in

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IVD generalNot specifiedOn the market

Manufacturer: Serosep Limited
Manufacturer SRN: IE-MF-000020322
UDI-DI: 05391513879616
Basic UDI-DI: B-05391513879616
Reference: EBFFS - VP1
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Ireland
Authorised representative: -
Last updated: 20.06.2026 05:34

Manufacturer products View details

EntericBio® Dx plug-in

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IVD generalNot specifiedOn the market

Manufacturer: Serosep Limited
Manufacturer SRN: IE-MF-000020322
UDI-DI: 05391513879609
Basic UDI-DI: B-05391513879609
Reference: EBFFS - GPDx
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Ireland
Authorised representative: -
Last updated: 20.06.2026 05:34

Manufacturer products View details

EntericBio® Viral Panel 3 plug-in

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IVD generalNot specifiedOn the market

Manufacturer: Serosep Limited
Manufacturer SRN: IE-MF-000020322
UDI-DI: 05391513879593
Basic UDI-DI: B-05391513879593
Reference: EBFFS - VP3
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Ireland
Authorised representative: -
Last updated: 20.06.2026 05:34

Manufacturer products View details

EntericBio® CPE plug-in

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IVD generalNot specifiedOn the market

Manufacturer: Serosep Limited
Manufacturer SRN: IE-MF-000020322
UDI-DI: 05391513879579
Basic UDI-DI: B-05391513879579
Reference: EBFFS - CPE
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Ireland
Authorised representative: -
Last updated: 20.06.2026 05:34

Manufacturer products View details