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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

384-Well Spectral Calibration Plate with ROX Dye

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

Manufacturer: Life Technologies Holdings Pte Ltd
Manufacturer SRN: SG-MF-000023931
UDI-DI: 10190302000307
Basic UDI-DI: 0190302TCF0000576BAM
Reference: 4432458
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

96-Well Spectral Calibration Plate with FAM Dye

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

Manufacturer: Life Technologies Holdings Pte Ltd
Manufacturer SRN: SG-MF-000023931
UDI-DI: 10190302000338
Basic UDI-DI: 0190302TCF0000576BAM
Reference: 4432538
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

96-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: 10190302000345
Basic UDI-DI: 0190302TCF0000576BAM
Reference: 4432545
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

96-Well Spectral Calibration Plate with ROX Dye

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

Manufacturer: Life Technologies Holdings Pte Ltd
Manufacturer SRN: SG-MF-000023931
UDI-DI: 10190302000352
Basic UDI-DI: 0190302TCF0000576BAM
Reference: 4432551
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

RNase P 96-Well Instrument Verification Plate

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

Manufacturer: Life Technologies Holdings Pte Ltd
Manufacturer SRN: SG-MF-000023931
UDI-DI: 10190302000369
Basic UDI-DI: 0190302TCF0000576CAP
Reference: 4432593
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

Fast 96-Well Spectral Calibration Plate with FAM Dye

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

Manufacturer: Life Technologies Holdings Pte Ltd
Manufacturer SRN: SG-MF-000023931
UDI-DI: 10190302000376
Basic UDI-DI: 0190302TCF0000576BAM
Reference: 4432600
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

FAST 96-Well Spectral Calibration 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: 10190302000383
Basic UDI-DI: 0190302TCF0000576BAM
Reference: 4432607
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

Fast 96-Well Spectral Calibration Plate with ROX Dye

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

Manufacturer: Life Technologies Holdings Pte Ltd
Manufacturer SRN: SG-MF-000023931
UDI-DI: 10190302000390
Basic UDI-DI: 0190302TCF0000576BAM
Reference: 4432614
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

384-Well Normalization Plates with FAM/ROX and VIC/ROX Dyes

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

Manufacturer: Life Technologies Holdings Pte Ltd
Manufacturer SRN: SG-MF-000023931
UDI-DI: 10190302000406
Basic UDI-DI: 0190302TCF0000576BAM
Reference: 4432620
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

96‑Well Region of Interest (ROI) and Background Plates

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: Life Technologies Holdings Pte Ltd
Manufacturer SRN: SG-MF-000023931
UDI-DI: 10190302000413
Basic UDI-DI: 0190302TCF0000576AAK
Reference: 4432626
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

FAST 96-Well Spectral Calibration with TAMRA™ Dye

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

Manufacturer: Life Technologies Holdings Pte Ltd
Manufacturer SRN: SG-MF-000023931
UDI-DI: 10190302000420
Basic UDI-DI: 0190302TCF0000576BAM
Reference: 4432632
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

FAST 96-Well Region of Interest (ROI) and Background Plates

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: Life Technologies Holdings Pte Ltd
Manufacturer SRN: SG-MF-000023931
UDI-DI: 10190302000437
Basic UDI-DI: 0190302TCF0000576AAK
Reference: 4432638
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