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SAMBA III Assay Module

I190007AM

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

Manufacturer: Diagnostics for the Real World (Europe) Ltd.
Manufacturer SRN: UK-MF-000047660
UDI-DI: ++G763I190007AM0
Basic UDI-DI: ++G763I190007AMZG
Reference: I190007AM
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Ireland
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 15.07.2026 21:30

Manufacturer products Authorised representative products Authorised representative actors View details

T-COR 8 Reaction Tube

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testingSingle use

Manufacturer: Tetracore INC
Manufacturer SRN: US-MF-000023064
UDI-DI: Not_app
Basic UDI-DI: ++G143TC8ReactionTubeWS
Reference: TC-5029-500
EMDN: W02050185
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES
First on market country: Spain
Authorised representative: Emergo Europe B.V.
Last updated: 15.07.2026 19:39

Manufacturer products Authorised representative products Authorised representative actors View details

T-COR 8 Magnetic Mixer

Rev B

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Tetracore INC
Manufacturer SRN: US-MF-000023064
UDI-DI: None
Basic UDI-DI: ++G143TC8MagneticMixerY5
Reference: TC-5018-001
EMDN: W02050180
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - HARDWARE ACCESSORIES
First on market country: Spain
Authorised representative: Emergo Europe B.V.
Last updated: 15.07.2026 19:39

Manufacturer products Authorised representative products Authorised representative actors View details

T-COR 8

Rev D

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Tetracore INC
Manufacturer SRN: US-MF-000023064
UDI-DI: NA
Basic UDI-DI: ++G143TC8RTPCRInstKF
Reference: TC-5049-001
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Spain
Authorised representative: Emergo Europe B.V.
Last updated: 15.07.2026 19:39

Manufacturer products Authorised representative products Authorised representative actors View details

ViraChip Software

Software

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testing

Manufacturer: Viramed Biotech AG
Manufacturer SRN: DE-MF-000020368
UDI-DI: EVIRVCNUPR1
Basic UDI-DI: ++EVIRSoftware98
Reference: V-VCNUPR
EMDN: W02050292
EMDN description: MICRO-ARRAY INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 19:24

Manufacturer products View details

ViraChip Scanner

Laboratory Device

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testing

Manufacturer: Viramed Biotech AG
Manufacturer SRN: DE-MF-000020368
UDI-DI: +EVIRUVCSCA1
Basic UDI-DI: ++EVIRLaboratoryDeviceFP
Reference: V-UVCSCA
EMDN: W02050107
EMDN description: MICRO-ARRAY SCANNERS
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 19:21

Manufacturer products View details

BGI

knowliter-1

IVD generalIVDDOn the marketProfessional testing

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: D-knowliter-1KS
Basic UDI-DI: B-knowliter-1KS
Reference: knowliter-1
EMDN: W02050182
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - SOFTWARE ACCESSORIES
First on market country: Denmark
Authorised representative: -
Last updated: 15.07.2026 14:20

Manufacturer products View details

Low-pass whole-genome aneuploidy Dx Mosaic w1.0

Low-pass whole-genome aneuploidy Dx Mosaic w1.0, a part of Ion Reporter (IR) Software Aneuploidy Dx Workflows

IVD Annex II List BIVDDOn the marketProfessional testing

Manufacturer: Life Technologies Corporation
Manufacturer SRN: US-MF-000023929
UDI-DI: D-USMF000023929A538508G
Basic UDI-DI: B-USMF000023929A538508G
Reference: A53850
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Netherlands
Authorised representative: Life Technologies Europe B.V.
Last updated: 15.07.2026 11:47

Manufacturer products Authorised representative products Authorised representative actors View details

Low-pass whole-genome aneuploidy Dx w1.0

Low-pass whole-genome aneuploidy Dx w1.0, a part of Ion Reporter (IR) Software Aneuploidy Dx Workflows

IVD Annex II List BIVDDOn the marketProfessional testing

Manufacturer: Life Technologies Corporation
Manufacturer SRN: US-MF-000023929
UDI-DI: D-USMF000023929A538488V
Basic UDI-DI: B-USMF000023929A538488V
Reference: A53848
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Netherlands
Authorised representative: Life Technologies Europe B.V.
Last updated: 15.07.2026 11:47

Manufacturer products Authorised representative products Authorised representative actors View details

Oncomine™ Dx Express Test - Plasma - v2.1.0 ADF

Oncomine™ Dx Express Test - Plasma - v2.1.0 ADF, a part of Ion Torrent™ Oncomine™ Dx Express Test

IVD generalIVDDOn the marketProfessional testing

Manufacturer: Life Technologies Corporation
Manufacturer SRN: US-MF-000023929
UDI-DI: D-USMF000023929A40010738W
Basic UDI-DI: B-USMF000023929A40010738W
Reference: A40010734
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: 15.07.2026 11:47

Manufacturer products Authorised representative products Authorised representative actors View details

Oncomine™ Dx Express Test - FFPE - v2.1.0 ADF

Oncomine™ Dx Express Test - FFPE - v2.1.0 ADF, a part of Ion Torrent™ Oncomine™ Dx Express Test

IVD generalIVDDOn the marketProfessional testing

Manufacturer: Life Technologies Corporation
Manufacturer SRN: US-MF-000023929
UDI-DI: D-USMF000023929A40004679G
Basic UDI-DI: B-USMF000023929A40004679G
Reference: A40004674
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: 15.07.2026 11:47

Manufacturer products Authorised representative products Authorised representative actors View details

BGI

SIGVAR

IVD generalIVDDOn the marketProfessional testing

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: D-SIGVARNZ
Basic UDI-DI: B-SIGVARNZ
Reference: SIGVAR
EMDN: W02050182
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - SOFTWARE ACCESSORIES
First on market country: Denmark
Authorised representative: -
Last updated: 15.07.2026 06:29

Manufacturer products View details

Real-time PCR instrument DTprime 4M1