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D-81649002MFIA02F7JY

MFIA02-E

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-81649002MFIA02F7JY
Basic UDI-DI: B-81649002MFIA02F7JY
Reference: MFIA02-E
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 10:05

Manufacturer products Authorised representative products Authorised representative actors View details

KMRengine® Standard Entry (1 year)

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: Genome Diagnostics B.V.
Manufacturer SRN: NL-MF-000000453
UDI-DI: D-48499514C
Basic UDI-DI: B-48499514C
Reference: 4849951
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Netherlands
Authorised representative: -
Last updated: 11.07.2026 20:17

Manufacturer products View details

KMRengine® Premium Entry (5 years)

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: Genome Diagnostics B.V.
Manufacturer SRN: NL-MF-000000453
UDI-DI: D-484985147
Basic UDI-DI: B-484985147
Reference: 4849851
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Netherlands
Authorised representative: -
Last updated: 11.07.2026 20:17

Manufacturer products View details

KMRengine® Standard Extension (+1 year)

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: Genome Diagnostics B.V.
Manufacturer SRN: NL-MF-000000453
UDI-DI: D-484975142
Basic UDI-DI: B-484975142
Reference: 4849751
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Netherlands
Authorised representative: -
Last updated: 11.07.2026 20:17

Manufacturer products View details

KMRengine® Premium Extension (+5 years)

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: Genome Diagnostics B.V.
Manufacturer SRN: NL-MF-000000453
UDI-DI: D-48496513V
Basic UDI-DI: B-48496513V
Reference: 4849651
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Netherlands
Authorised representative: -
Last updated: 11.07.2026 20:17

Manufacturer products View details

SYNCHRON UDR Kit (12-pack)

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-442835PY
Basic UDI-DI: B-442835PY
Reference: 442835
EMDN: W02050185
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:46

Manufacturer products Authorised representative products Authorised representative actors View details

GT NUCLEIC ACID PREP KIT

IVD Class ANot specifiedOn the marketKitProfessional testingReagent

Manufacturer: Genomictree, Inc.
Manufacturer SRN: KR-MF-000037890
UDI-DI: 18800076500508
Basic UDI-DI: 88000765PREP1PX
Reference: GT-PREP-3
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: -
Authorised representative: KTR Europe GmbH
Last updated: 11.07.2026 12:06

Manufacturer products Authorised representative products Authorised representative actors View details

Oncomine™ Dx Target Test User Guides and Assay Definition File

Oncomine™ Dx Target Test User Guides and Assay Definition File, a part of Oncomine™ Dx Target Test

IVD generalIVDDOn the marketProfessional testing

Manufacturer: Life Technologies Corporation
Manufacturer SRN: US-MF-000023929
UDI-DI: 10190302017763
Basic UDI-DI: B-10190302017763
Reference: A52639 (A49756)
EMDN: W02050182
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - SOFTWARE ACCESSORIES
First on market country: Netherlands
Authorised representative: Life Technologies Europe B.V.
Last updated: 11.07.2026 00:40

Manufacturer products Authorised representative products Authorised representative actors View details

InfectID-Client Software

V1.1

IVD generalIVDDOn the marketProfessional testingSingle use

Manufacturer: Microbio Ltd
Manufacturer SRN: AU-MF-000033903
UDI-DI: 09309001216023
Basic UDI-DI: B-09309001216023
Reference: V1.1
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Czechia
Authorised representative: Qualrep Services B.V.
Last updated: 10.07.2026 22:37

Manufacturer products Authorised representative products Authorised representative actors View details

Illumina DRAGEN® Server for NextSeq550Dx

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Illumina, Inc.
Manufacturer SRN: US-MF-000013476
UDI-DI: 00816270020811
Basic UDI-DI: 0081627002NEXTSEQAD
Reference: 20086130
EMDN: W02050115
EMDN description: DNA SYNTHESIZERS
First on market country: -
Authorised representative: Illumina Netherlands B.V.
Last updated: 09.07.2026 22:57

Manufacturer products Authorised representative products Authorised representative actors View details

Sentosa ST401i