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987 device results listed.

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FluoroCycler® XT

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hain Lifescience GmbH
Manufacturer SRN: DE-MF-000008606
UDI-DI: 04049055003396
Basic UDI-DI: 40490550300001072UG
Reference: 2017
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:47

Manufacturer products View details

FluoroCycler® 12

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hain Lifescience GmbH
Manufacturer SRN: DE-MF-000008606
UDI-DI: 04049055002993
Basic UDI-DI: 40490550300001070UC
Reference: 7027001
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:47

Manufacturer products View details

TwinCubator

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hain Lifescience GmbH
Manufacturer SRN: DE-MF-000008606
UDI-DI: 04049055002641
Basic UDI-DI: 40490550300001078UU
Reference: 7025009
EMDN: W02050101
EMDN description: NUCLEIC ACID HYBRIDIZATION UNITS
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:47

Manufacturer products View details

GT-Blot 48

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hain Lifescience GmbH
Manufacturer SRN: DE-MF-000008606
UDI-DI: 04049055000500
Basic UDI-DI: 40490550300001077US
Reference: 1003/1
EMDN: W02050101
EMDN description: NUCLEIC ACID HYBRIDIZATION UNITS
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:47

Manufacturer products View details

03770028804030

Congenica Rare Disease

IVD Class CIVDR 2017/746On the marketDirect marking

Manufacturer: SEQONE
Manufacturer SRN: FR-MF-000028525
UDI-DI: 03770028804030
Basic UDI-DI: 3770028804CRD6G
Reference: CRD
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Ireland
Authorised representative: -
Last updated: 01.07.2026 16:09

Manufacturer products View details

03770028804023

Variant LifePipe

IVD Class CIVDR 2017/746On the marketDirect marking

Manufacturer: SEQONE
Manufacturer SRN: FR-MF-000028525
UDI-DI: 03770028804023
Basic UDI-DI: 3770028804VLP9M
Reference: VLP
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 16:09

Manufacturer products View details

Ziwig Endotest

Endotest Diagnostic

IVD Class CIVDR 2017/746On the marketDirect markingProfessional testing

Manufacturer: Ziwig
Manufacturer SRN: FR-MF-000024009
UDI-DI: 03770025060026
Basic UDI-DI: 3770025060ED100JB
Reference: ED100
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 16:06

Manufacturer products View details

Smart GUARD

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: APPOLON BIOTECK
Manufacturer SRN: FR-MF-000022234
UDI-DI: 03760322820058
Basic UDI-DI: 376032282AINS22176
Reference: AB0096
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 15:25

Manufacturer products View details

MAP-AD Test Software - Frontend

MAP-AD Test Software

IVD Class CIVDR 2017/746On the marketDirect markingProfessional testing

Manufacturer: ADmit Therapeutics
Manufacturer SRN: ES-MF-000042518
UDI-DI: 08437026887124
Basic UDI-DI: 8437026887AD002YK
Reference: AD002
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Spain
Authorised representative: -
Last updated: 30.06.2026 15:37

Manufacturer products View details

MAP-AD Test Software - Frontend

MAP-AD Test Software

IVD Class CIVDR 2017/746On the marketDirect markingProfessional testing

Manufacturer: ADmit Therapeutics
Manufacturer SRN: ES-MF-000042518
UDI-DI: 08437026887117
Basic UDI-DI: 8437026887AD002YK
Reference: AD002
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Spain
Authorised representative: -
Last updated: 30.06.2026 15:37

Manufacturer products View details

MAP-AD Test Software - Frontend

MAP-AD Test Software

IVD Class CIVDR 2017/746On the marketDirect markingProfessional testing

Manufacturer: ADmit Therapeutics
Manufacturer SRN: ES-MF-000042518
UDI-DI: 08437026887100
Basic UDI-DI: 8437026887AD002YK
Reference: AD002
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Spain
Authorised representative: -
Last updated: 30.06.2026 15:37

Manufacturer products View details

MAP-AD Test Software - Backend

MAP-AD Test Software

IVD Class CIVDR 2017/746On the marketProfessional testing

Manufacturer: ADmit Therapeutics
Manufacturer SRN: ES-MF-000042518
UDI-DI: 08437026887094
Basic UDI-DI: 8437026887AD002YK
Reference: AD002
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Spain
Authorised representative: -
Last updated: 30.06.2026 15:37

Manufacturer products View details

A1AT Genotyping Test

A1AT Genotyping Test ANALYSIS SOFTWARE

IVD Class CIVDR 2017/746On the marketDirect markingProfessional testing

Manufacturer: Progenika Biopharma, S.A.
Manufacturer SRN: ES-MF-000001005
UDI-DI: 08437013457705
Basic UDI-DI: 8437013457Gentest004QR
Reference: 1292320000/1292380000
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Spain
Authorised representative: -
Last updated: 30.06.2026 15:34

Manufacturer products View details

ID HPA XT

ID HPA XT ANALYSIS SOFTWARE

IVD Class CIVDR 2017/746On the marketDirect markingProfessional testing

Manufacturer: Progenika Biopharma, S.A.
Manufacturer SRN: ES-MF-000001005
UDI-DI: 08437013457699
Basic UDI-DI: 8437013457Gentest003QP
Reference: 1010220034
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Spain
Authorised representative: -
Last updated: 30.06.2026 15:34

Manufacturer products View details

GenomEra CDX Software

IVD Class ANot specifiedNo longer on the market

Manufacturer: Uniogen Oy
Manufacturer SRN: FI-MF-000032341
UDI-DI: 06438556100310
Basic UDI-DI: 6438556CDX-10RB
Reference: CDX-10-031
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Finland
Authorised representative: -
Last updated: 29.06.2026 14:30

Manufacturer products View details

POP-6™ Polymer Dx (960 Samples)

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Life Technologies Holdings Pte Ltd
Manufacturer SRN: SG-MF-000023931
UDI-DI: 10190302000154
Basic UDI-DI: 01903024393709CW
Reference: 4393711
EMDN: W02050185
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES
First on market country: -
Authorised representative: Life Technologies Europe B.V.
Last updated: 29.06.2026 10:51

Manufacturer products Authorised representative products Authorised representative actors View details

POP-7™ Polymer Dx (960 Samples)

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Life Technologies Holdings Pte Ltd
Manufacturer SRN: SG-MF-000023931
UDI-DI: 10190302000161
Basic UDI-DI: 01903024393709CW
Reference: 4393713
EMDN: W02050185
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES
First on market country: -
Authorised representative: Life Technologies Europe B.V.
Last updated: 29.06.2026 10:51

Manufacturer products Authorised representative products Authorised representative actors View details

POP-6™ Polymer Dx (384 Samples)

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Life Technologies Holdings Pte Ltd
Manufacturer SRN: SG-MF-000023931
UDI-DI: 10190302000178
Basic UDI-DI: 01903024393709CW
Reference: 4393716
EMDN: W02050185
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES
First on market country: -
Authorised representative: Life Technologies Europe B.V.
Last updated: 29.06.2026 10:51

Manufacturer products Authorised representative products Authorised representative actors View details

3500xL Dx Capillary Array 50-cm

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Life Technologies Holdings Pte Ltd
Manufacturer SRN: SG-MF-000023931
UDI-DI: 10190302000215
Basic UDI-DI: 01903024404682AL
Reference: 4404688
EMDN: W02050185
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES
First on market country: -
Authorised representative: Life Technologies Europe B.V.
Last updated: 29.06.2026 10:51

Manufacturer products Authorised representative products Authorised representative actors View details

384-Well Spectral Calibration Plate with VIC Dye

IVD Class AIVDR 2017/746On the marketHuman tissuesProfessional testingSingle use

Manufacturer: Life Technologies Holdings Pte Ltd
Manufacturer SRN: SG-MF-000023931
UDI-DI: 10190302000291
Basic UDI-DI: 0190302TCF0000576BAM
Reference: 4432452
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: -
Authorised representative: Life Technologies Europe B.V.
Last updated: 29.06.2026 10:51

Manufacturer products Authorised representative products Authorised representative actors View details