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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

29418000002cxSTA

2cx-CRCSTA

IVD Class AIVDR 2017/746On the marketAnimal tissuesHuman tissuesInstrumentProfessional testingSingle use

Manufacturer: 2cureX A/S
Manufacturer SRN: DK-MF-000036335
UDI-DI: 29418000002cxSTA
Basic UDI-DI: 2321183242cxCRCSTAGN
Reference: 2cx-CRCSTA
EMDN: W02050285
EMDN description: MICRO-ARRAY INSTRUMENTS - CONSUMABLES
First on market country: Denmark
Authorised representative: -
Last updated: 01.07.2026 12:09

Manufacturer products View details

29418000002cxEXT

2cx-CRCEXT

IVD Class AIVDR 2017/746On the marketAnimal tissuesHuman tissuesInstrumentProfessional testingSingle use

Manufacturer: 2cureX A/S
Manufacturer SRN: DK-MF-000036335
UDI-DI: 29418000002cxEXT
Basic UDI-DI: 2321183242cxCRCEXTG2
Reference: 2cx-CRCEXT
EMDN: W02050285
EMDN description: MICRO-ARRAY INSTRUMENTS - CONSUMABLES
First on market country: Denmark
Authorised representative: -
Last updated: 01.07.2026 12:09

Manufacturer products View details

29418000002cxEXP

2cx-CRCEXP

IVD Class AIVDR 2017/746On the marketAnimal tissuesHuman tissuesInstrumentProfessional testingSingle use

Manufacturer: 2cureX A/S
Manufacturer SRN: DK-MF-000036335
UDI-DI: 29418000002cxEXP
Basic UDI-DI: 2321183242cxCRCEXPFS
Reference: 2cx-CRCEXP
EMDN: W02050285
EMDN description: MICRO-ARRAY INSTRUMENTS - CONSUMABLES
First on market country: Denmark
Authorised representative: -
Last updated: 01.07.2026 12:09

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

Advyser Chimerism

IVD Class CIVDR 2017/746On the marketDirect markingProfessional testing

Manufacturer: Devyser AB
Manufacturer SRN: SE-MF-000001699
UDI-DI: 07350040635148
Basic UDI-DI: 7350040638R113RA
Reference: 8-R113
EMDN: W02050392
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS - RAPID AND POINT OF CARE TESTS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Sweden
Authorised representative: -
Last updated: 30.06.2026 12:48

Manufacturer products View details

Advyser Solid Organs

IVD Class CIVDR 2017/746On the marketDirect markingProfessional testing

Manufacturer: Devyser AB
Manufacturer SRN: SE-MF-000001699
UDI-DI: 07350040631881
Basic UDI-DI: 7350040638R116RG
Reference: 8-R116
EMDN: W02050392
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS - RAPID AND POINT OF CARE TESTS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Sweden
Authorised representative: -
Last updated: 30.06.2026 12:48

Manufacturer products View details

Automated PCR Analysis System

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: FlashDx Shenzhen Inc
Manufacturer SRN: CN-MF-000025748
UDI-DI: 06974936201067
Basic UDI-DI: 6974936202010408121UB
Reference: FlashDx® sSPRT™ 8T
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: -
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 29.06.2026 22:59

Manufacturer products Authorised representative products Authorised representative actors View details

Automated PCR Analysis System

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: FlashDx Shenzhen Inc
Manufacturer SRN: CN-MF-000025748
UDI-DI: 06974936201074
Basic UDI-DI: 6974936202010408121UB
Reference: FlashDx® sSPRT™ 12T
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: -
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 29.06.2026 22:59

Manufacturer products Authorised representative products Authorised representative actors 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