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Alinity m

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: Abbott Molecular Inc.
Manufacturer SRN: US-MF-000017776
UDI-DI: 30884999048103
Basic UDI-DI: 0884999AMN0949Y7
Reference: 09N49-010
EMDN: W02050185
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES
First on market country: -
Authorised representative: Abbott GmbH
Last updated: 21.09.2026 21:10

Manufacturer products Authorised representative products Authorised representative actors View details

04582754078017

IX85

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: Evident Corporation
Manufacturer SRN: JP-MF-000027470
UDI-DI: 04582754078017
Basic UDI-DI: 458264313IX85DP
Reference: N6870700
EMDN: W0202050303
EMDN description: OPTICAL LABORATORY MICROSCOPES
First on market country: Germany
Authorised representative: Evident Europe GmbH
Last updated: 21.09.2026 21:05

Manufacturer products Authorised representative products Authorised representative actors View details

04582754078024

IVD Class ANot specifiedOn the marketInstrument

Manufacturer: Evident Corporation
Manufacturer SRN: JP-MF-000027470
UDI-DI: 04582754078024
Basic UDI-DI: 458264313IX85DP
Reference: N6870800
EMDN: W0202050303
EMDN description: OPTICAL LABORATORY MICROSCOPES
First on market country: -
Authorised representative: Evident Europe GmbH
Last updated: 21.09.2026 21:01

Manufacturer products Authorised representative products Authorised representative actors View details

Microlab STARlet IVD-R

806670

IVD Class AIVDR 2017/746No longer on the marketDirect markingInstrument

Manufacturer: Hamilton AG
Manufacturer SRN: CH-MF-000013585
UDI-DI: 07630032652316
Basic UDI-DI: 76300326806670MT
Reference: 806670
EMDN: W02060199
EMDN description: ROBOTIC SAMPLE PROCESSING SYSTEMS - OTHER
First on market country: Austria
Authorised representative: Johner Medical GmbH
Last updated: 21.09.2026 21:00

Manufacturer products Authorised representative products Authorised representative actors View details

Idylla™ Console

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Biocartis NV
Manufacturer SRN: BE-MF-000003661
UDI-DI: 05415219000126
Basic UDI-DI: 5415219P0010GM
Reference: P1010
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Belgium
Authorised representative: -
Last updated: 21.09.2026 21:00

Manufacturer products View details

Idylla™ Hub

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Biocartis NV
Manufacturer SRN: BE-MF-000003661
UDI-DI: 05415219001390
Basic UDI-DI: 5415219P0010GM
Reference: P1030
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Belgium
Authorised representative: -
Last updated: 21.09.2026 21:00

Manufacturer products View details

Idylla™ Instrument

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Biocartis NV
Manufacturer SRN: BE-MF-000003661
UDI-DI: 05415219000119
Basic UDI-DI: 5415219P0010GM
Reference: P0010
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Belgium
Authorised representative: -
Last updated: 21.09.2026 21:00

Manufacturer products View details

Myriapod NGS Hereditary probe

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: DIATECH PHARMACOGENETICS SRL
Manufacturer SRN: IT-MF-000018670
UDI-DI: 08057289091313
Basic UDI-DI: 8057289090000ANG0397C
Reference: NG039
EMDN: W02050185
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES
First on market country: Italy
Authorised representative: -
Last updated: 21.09.2026 20:47

Manufacturer products View details

Thrombo Fast +

CD12-1-17

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: LABiTec LAbor BioMedical Technologies GmbH
Manufacturer SRN: DE-MF-000020928
UDI-DI: 04051088110125
Basic UDI-DI: 4051088CD12X173Y
Reference: 112-99-620-xx
EMDN: W0202020101
EMDN description: SEMI-AUTOMATED COAGULOMETERS
First on market country: Northern Ireland
Authorised representative: -
Last updated: 21.09.2026 20:32

Manufacturer products View details

RAL Stainer Filter Cartridge

IVD Class AIVDR 2017/746On the market

Manufacturer: RAL Diagnostics
Manufacturer SRN: FR-MF-000007902
UDI-DI: 03760177198203
Basic UDI-DI: 376017719405110HX
Reference: 405110
EMDN: W02029085
EMDN description: VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - CONSUMABLES
First on market country: Belgium
Authorised representative: -
Last updated: 21.09.2026 20:28

Manufacturer products View details

03760177194892

Pack of RAL Stainer Slide-holder x3

IVD Class AIVDR 2017/746On the market

Manufacturer: RAL Diagnostics
Manufacturer SRN: FR-MF-000007902
UDI-DI: 03760177194892
Basic UDI-DI: 376017719405108JC
Reference: 405108
EMDN: W02029085
EMDN description: VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - CONSUMABLES
First on market country: Belgium
Authorised representative: -
Last updated: 21.09.2026 20:28

Manufacturer products View details

Rinsing Station RAL Stainer

IVD Class ANot specifiedOn the market

Manufacturer: RAL Diagnostics
Manufacturer SRN: FR-MF-000007902
UDI-DI: 03760177194885
Basic UDI-DI: 376017719405120J2
Reference: 405120
EMDN: W02029085
EMDN description: VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - CONSUMABLES
First on market country: Belgium
Authorised representative: -
Last updated: 21.09.2026 20:28

Manufacturer products View details

RAL Stainer 10L Jerrycan

IVD Class AIVDR 2017/746On the market

Manufacturer: RAL Diagnostics
Manufacturer SRN: FR-MF-000007902
UDI-DI: 03760177194861
Basic UDI-DI: 376017719405126JE
Reference: 405126
EMDN: W02029085
EMDN description: VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - CONSUMABLES
First on market country: Belgium
Authorised representative: -
Last updated: 21.09.2026 20:28

Manufacturer products View details

03760177194625

RAL TB Stainer

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: RAL Diagnostics
Manufacturer SRN: FR-MF-000007902
UDI-DI: 03760177194625
Basic UDI-DI: 376017719414195K5
Reference: 414195
EMDN: W0202059002
EMDN description: AUTOMATED SLIDE STAINERS
First on market country: France
Authorised representative: -
Last updated: 21.09.2026 20:28

Manufacturer products View details

RAL Stainer

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: RAL Diagnostics
Manufacturer SRN: FR-MF-000007902
UDI-DI: 03760177194199
Basic UDI-DI: 376017719405000HP
Reference: 405000
EMDN: W0202059002
EMDN description: AUTOMATED SLIDE STAINERS
First on market country: Austria
Authorised representative: -
Last updated: 21.09.2026 20:28

Manufacturer products View details

FilmArray® Torch System

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: BioFire Diagnostics, LLC
Manufacturer SRN: US-MF-000003311
UDI-DI: 00815381020253
Basic UDI-DI: 357302BUDI000922TZ
Reference: HTFA-ASY-0104
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: France
Authorised representative: bioMérieux SA
Last updated: 21.09.2026 20:23

Manufacturer products Authorised representative products Authorised representative actors View details

DxU 840m Iris

C76947

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: Beckman Coulter Ireland Inc.
Manufacturer SRN: IE-MF-000000887
UDI-DI: 15099590748654
Basic UDI-DI: B-15099590748654
Reference: C76947
EMDN: W02010701
EMDN description: URINALYSIS (UR) - LABORATORY ANALYSERS- INSTRUMENTS
First on market country: Ireland
Authorised representative: -
Last updated: 21.09.2026 19:58

Manufacturer products View details

DxU 850m Iris

C49513

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: Beckman Coulter Ireland Inc.
Manufacturer SRN: IE-MF-000000887
UDI-DI: 15099590748647
Basic UDI-DI: B-15099590748647
Reference: C49513
EMDN: W02010701
EMDN description: URINALYSIS (UR) - LABORATORY ANALYSERS- INSTRUMENTS
First on market country: Ireland
Authorised representative: -
Last updated: 21.09.2026 19:58

Manufacturer products View details

biobas 10

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: LABiTec LAbor BioMedical Technologies GmbH
Manufacturer SRN: DE-MF-000020928
UDI-DI: 04051088110040
Basic UDI-DI: 4051088CD12X173Y
Reference: 5003005
EMDN: W0202020101
EMDN description: SEMI-AUTOMATED COAGULOMETERS
First on market country: -
Authorised representative: -
Last updated: 21.09.2026 19:21

Manufacturer products View details

DCA-4

CD12-1-17

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: LABiTec LAbor BioMedical Technologies GmbH
Manufacturer SRN: DE-MF-000020928
UDI-DI: 04051088110101
Basic UDI-DI: 4051088CD12X173Y
Reference: 40.004
EMDN: W0202020101
EMDN description: SEMI-AUTOMATED COAGULOMETERS
First on market country: Netherlands
Authorised representative: -
Last updated: 21.09.2026 19:20

Manufacturer products View details