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04262601890008

Tissue Scanner

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

Manufacturer: Histolution GmbH
Manufacturer SRN: DE-MF-000055003
UDI-DI: 04262601890008
Basic UDI-DI: 426260189TissueScannerW3
Reference: PAN.001
EMDN: W0202050304
EMDN description: DIGITAL LABORATORY MICROSCOPES
First on market country: Germany
Authorised representative: -
Last updated: 11.08.2026 06:49

Manufacturer products View details

Konan CellChek D CD-15

N/A

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Konan Medical, Inc.
Manufacturer SRN: JP-MF-000005193
UDI-DI: 04582275250404
Basic UDI-DI: 458227526KONAN-ESPLB
Reference: N/A
EMDN: W0202050304
EMDN description: DIGITAL LABORATORY MICROSCOPES
First on market country: Malta
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 07.08.2026 17:38

Manufacturer products Authorised representative products Authorised representative actors View details

NanoZoomer S360MD Slide scanner system

C13220-21MDEU

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hamamatsu Photonics K.K., Systems Division
Manufacturer SRN: JP-MF-000019003
UDI-DI: 04582389010697
Basic UDI-DI: 4582389NNZM36001MU
Reference: C13220-21MDEU
EMDN: W0202050304
EMDN description: DIGITAL LABORATORY MICROSCOPES
First on market country: Germany
Authorised representative: Hamamatsu Photonics Deutschland GmbH
Last updated: 07.08.2026 17:38

Manufacturer products Authorised representative products Authorised representative actors View details

NanoZoomer S20MD Slide scanner system

C16300-21MDEU

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hamamatsu Photonics K.K., Systems Division
Manufacturer SRN: JP-MF-000019003
UDI-DI: 04582389010741
Basic UDI-DI: 4582389NNZM02001KX
Reference: C16300-21MDEU
EMDN: W0202050304
EMDN description: DIGITAL LABORATORY MICROSCOPES
First on market country: Germany
Authorised representative: Hamamatsu Photonics Deutschland GmbH
Last updated: 07.08.2026 17:38

Manufacturer products Authorised representative products Authorised representative actors View details

NanoZoomer S60v2MD Slide scanner system

IVD Class ANot specifiedOn the market

Manufacturer: Hamamatsu Photonics K.K., Systems Division
Manufacturer SRN: JP-MF-000019003
UDI-DI: 04582389010789
Basic UDI-DI: 4582389NNZM06001LT
Reference: C16600-21MDEU
EMDN: W0202050304
EMDN description: DIGITAL LABORATORY MICROSCOPES
First on market country: Germany
Authorised representative: Hamamatsu Photonics Deutschland GmbH
Last updated: 07.08.2026 17:38

Manufacturer products Authorised representative products Authorised representative actors View details

NanoZoomer S540MD Slide scanner system

C17400-21MDEU

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hamamatsu Photonics K.K., Systems Division
Manufacturer SRN: JP-MF-000019003
UDI-DI: 04582389011212
Basic UDI-DI: 4582389NNZM54001N4
Reference: C17400-21MDEU
EMDN: W0202050304
EMDN description: DIGITAL LABORATORY MICROSCOPES
First on market country: Germany
Authorised representative: Hamamatsu Photonics Deutschland GmbH
Last updated: 07.08.2026 17:38

Manufacturer products Authorised representative products Authorised representative actors View details

Agilent S540MD Slide Scanner System

C17400-51MDEU

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hamamatsu Photonics K.K., Systems Division
Manufacturer SRN: JP-MF-000019003
UDI-DI: 04582389011328
Basic UDI-DI: 4582389AGIL54001X3
Reference: C17400-51MDEU
EMDN: W0202050304
EMDN description: DIGITAL LABORATORY MICROSCOPES
First on market country: Denmark
Authorised representative: Hamamatsu Photonics Deutschland GmbH
Last updated: 07.08.2026 17:38

Manufacturer products Authorised representative products Authorised representative actors View details

Immage Navigator®

IN110

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Immuno Concepts N.A., Ltd.
Manufacturer SRN: US-MF-000054193
UDI-DI: M74900IN1101
Basic UDI-DI: ++M749INFW
Reference: IN110
EMDN: W0202050382
EMDN description: LABORATORY INSTRUMENTS FOR MICROSCOPIC INVESTIGATIONS - SOFTWARE ACCESSORIES
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 06.08.2026 18:14

Manufacturer products Authorised representative products Authorised representative actors View details

04262392420095

Mindpeak AI Console

IVD generalIVDDOn the marketProfessional testing

Manufacturer: Mindpeak GmbH
Manufacturer SRN: DE-MF-000031982
UDI-DI: 04262392420095
Basic UDI-DI: B-04262392420095
Reference: AIC
EMDN: W0202050392
EMDN description: LABORATORY INSTRUMENTS FOR MICROSCOPIC INVESTIGATIONS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 12:40

Manufacturer products View details

Motic

Panthera E2 Panthera C2 Panthera DL Panthera Cloud PA43 PA53 BIO BA210E BA210LED BA310E BA310LED BA410E 50W BA410E 100W

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Motic China Group Co., Ltd.
Manufacturer SRN: CN-MF-000033671
UDI-DI: 06973967160657
Basic UDI-DI: 697396716Microscope001BG
Reference: BA310E
EMDN: W0202050303
EMDN description: OPTICAL LABORATORY MICROSCOPES
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 04.08.2026 22:16

Manufacturer products Authorised representative products Authorised representative actors View details

Aiforia® Clinical Suite Viewer

IVD generalIVDDOn the marketProfessional testing

Manufacturer: Aiforia Technologies Plc
Manufacturer SRN: FI-MF-000008986
UDI-DI: 06429810612069
Basic UDI-DI: B-06429810612069
Reference: Aiforia® Clinical Suite Viewer
EMDN: W0202050392
EMDN description: LABORATORY INSTRUMENTS FOR MICROSCOPIC INVESTIGATIONS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Finland
Authorised representative: -
Last updated: 03.08.2026 03:55

Manufacturer products View details

Aiforia® Clinical AI Model for Prostate Cancer; Gleason Grade Groups

IVD generalIVDDOn the marketProfessional testing

Manufacturer: Aiforia Technologies Plc
Manufacturer SRN: FI-MF-000008986
UDI-DI: 06429810612052
Basic UDI-DI: B-06429810612052
Reference: Aiforia® Clinical AI Model for Prostate Cancer; Gleason Grade Groups
EMDN: W0202050392
EMDN description: LABORATORY INSTRUMENTS FOR MICROSCOPIC INVESTIGATIONS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Finland
Authorised representative: -
Last updated: 03.08.2026 03:55

Manufacturer products View details

Aiforia® Clinical AI Model for Breast Cancer; PR

IVD generalIVDDOn the marketProfessional testing

Manufacturer: Aiforia Technologies Plc
Manufacturer SRN: FI-MF-000008986
UDI-DI: 06429810612045
Basic UDI-DI: B-06429810612045
Reference: Aiforia® Clinical AI Model for Breast Cancer; PR
EMDN: W0202050392
EMDN description: LABORATORY INSTRUMENTS FOR MICROSCOPIC INVESTIGATIONS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Finland
Authorised representative: -
Last updated: 03.08.2026 03:55

Manufacturer products View details

Aiforia® Clinical AI Model for Breast Cancer; ER

IVD generalIVDDOn the marketProfessional testing

Manufacturer: Aiforia Technologies Plc
Manufacturer SRN: FI-MF-000008986
UDI-DI: 06429810612038
Basic UDI-DI: B-06429810612038
Reference: Aiforia® Clinical AI Model for Breast Cancer; ER
EMDN: W0202050392
EMDN description: LABORATORY INSTRUMENTS FOR MICROSCOPIC INVESTIGATIONS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Finland
Authorised representative: -
Last updated: 03.08.2026 03:55

Manufacturer products View details

Aiforia® Clinical AI Model for Lung Cancer; PD-L1

IVD generalIVDDOn the marketProfessional testing

Manufacturer: Aiforia Technologies Plc
Manufacturer SRN: FI-MF-000008986
UDI-DI: 06429810612021
Basic UDI-DI: B-06429810612021
Reference: Aiforia® Clinical AI Model for Lung Cancer; PD-L1
EMDN: W0202050392
EMDN description: LABORATORY INSTRUMENTS FOR MICROSCOPIC INVESTIGATIONS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Finland
Authorised representative: -
Last updated: 03.08.2026 03:55

Manufacturer products View details

Aiforia® Clinical AI Model for Breast Cancer; Ki67

IVD generalIVDDOn the marketProfessional testing

Manufacturer: Aiforia Technologies Plc
Manufacturer SRN: FI-MF-000008986
UDI-DI: 06429810612014
Basic UDI-DI: B-06429810612014
Reference: Aiforia® Clinical AI Model for Breast Cancer; Ki67
EMDN: W0202050392
EMDN description: LABORATORY INSTRUMENTS FOR MICROSCOPIC INVESTIGATIONS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Finland
Authorised representative: -
Last updated: 03.08.2026 03:54

Manufacturer products View details

LUCIA Cytogenetics, version 4.2

LUCIA Cytogenetics

IVD Class CIVDR 2017/746On the marketProfessional testing

Manufacturer: Laboratory Imaging s.r.o.
Manufacturer SRN: CZ-MF-000025008
UDI-DI: 08594211580014
Basic UDI-DI: 859421158LCGQC
Reference: N/A
EMDN: W0202050392
EMDN description: LABORATORY INSTRUMENTS FOR MICROSCOPIC INVESTIGATIONS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Czechia
Authorised representative: -
Last updated: 31.07.2026 23:17

Manufacturer products View details

PREPSTAIN

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Becton, Dickinson and Company
Manufacturer SRN: US-MF-000018910
UDI-DI: 00382904914547
Basic UDI-DI: 038290FXHRELFOE9
Reference: 491454
EMDN: W0202050385
EMDN description: LABORATORY INSTRUMENTS FOR MICROSCOPIC INVESTIGATIONS - CONSUMABLES
First on market country: -
Authorised representative: Becton Dickinson Ireland Limited
Last updated: 31.07.2026 22:46

Manufacturer products Authorised representative products Authorised representative actors View details

Motic

AE31E AE2000 PX43 BIO

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Motic China Group Co., Ltd.
Manufacturer SRN: CN-MF-000033671
UDI-DI: 06973967160572
Basic UDI-DI: 697396716IBMicroscopeM2
Reference: AE2000
EMDN: W0202050303
EMDN description: OPTICAL LABORATORY MICROSCOPES
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 21:35

Manufacturer products Authorised representative products Authorised representative actors View details

Motic

Panthera E2 Panthera C2 Panthera DL Panthera Cloud PA43 PA53 BIO BA210E BA210LED BA310E BA310LED BA410E 50W BA410E 100W

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Motic China Group Co., Ltd.
Manufacturer SRN: CN-MF-000033671
UDI-DI: 06973967160114
Basic UDI-DI: 697396716Microscope001BG
Reference: Panthera DL
EMDN: W0202050303
EMDN description: OPTICAL LABORATORY MICROSCOPES
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 21:35

Manufacturer products Authorised representative products Authorised representative actors View details