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46 device results listed.

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Aiforia® Prostate Cancer G4 Cribriform

Aiforia® Prostate Cancer G4 Cribriform

IVD Class CIVDR 2017/746No longer on the marketDirect markingProfessional testing

Manufacturer: Aiforia Technologies Plc
Manufacturer SRN: FI-MF-000008986
UDI-DI: 06429810612083
Basic UDI-DI: 06429810612PR002Q4
Reference: Aiforia® Prostate Cancer G4 Cribriform
EMDN: W0202050392
EMDN description: LABORATORY INSTRUMENTS FOR MICROSCOPIC INVESTIGATIONS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Finland
Authorised representative: -
Last updated: 22.09.2026 00:41

Manufacturer products View details

Aiforia® Prostate Cancer PNI

Aiforia® Prostate Cancer PNI

IVD Class CIVDR 2017/746No longer on the marketDirect markingProfessional testing

Manufacturer: Aiforia Technologies Plc
Manufacturer SRN: FI-MF-000008986
UDI-DI: 06429810612106
Basic UDI-DI: 06429810612PR004Q8
Reference: Aiforia® Prostate Cancer PNI
EMDN: W0202050392
EMDN description: LABORATORY INSTRUMENTS FOR MICROSCOPIC INVESTIGATIONS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Finland
Authorised representative: -
Last updated: 22.09.2026 00:37

Manufacturer products View details

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

Aiforia® Clinical Suite Viewer

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

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

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

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

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

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

Case Manager DX

CaseManager DX

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: 3DHISTECH Kft.
Manufacturer SRN: HU-MF-000014337
UDI-DI: 05999571470150
Basic UDI-DI: 599957147155SE
Reference: DX-CASEM-0
EMDN: W0202050392
EMDN description: LABORATORY INSTRUMENTS FOR MICROSCOPIC INVESTIGATIONS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 16:39

Manufacturer products View details

PathoZoom® Scan & LiveView

Measurement Tool

IVD Class AIVDR 2017/746On the marketDirect marking

Manufacturer: Smart In Media AG
Manufacturer SRN: DE-MF-000029268
UDI-DI: 04262376670010
Basic UDI-DI: 426237667DL20190017T
Reference: 002
EMDN: W0202050392
EMDN description: LABORATORY INSTRUMENTS FOR MICROSCOPIC INVESTIGATIONS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 05:29

Manufacturer products View details

PathoZoom® Digital Lab

Measurement Tool

IVD Class AIVDR 2017/746On the marketDirect markingSingle use

Manufacturer: Smart In Media AG
Manufacturer SRN: DE-MF-000029268
UDI-DI: 04262376670003
Basic UDI-DI: 426237667DL20190017T
Reference: 1
EMDN: W0202050392
EMDN description: LABORATORY INSTRUMENTS FOR MICROSCOPIC INVESTIGATIONS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 05:23

Manufacturer products View details

Aiforia® Prostate Cancer Biopsy

Aiforia® Prostate Cancer Biopsy

IVD Class CIVDR 2017/746On the marketDirect marking

Manufacturer: Aiforia Technologies Plc
Manufacturer SRN: FI-MF-000008986
UDI-DI: 06429810612205
Basic UDI-DI: 06429810612PR005QA
Reference: Aiforia® Prostate Cancer Biopsy
EMDN: W0202050392
EMDN description: LABORATORY INSTRUMENTS FOR MICROSCOPIC INVESTIGATIONS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Finland
Authorised representative: -
Last updated: 30.07.2026 18:51

Manufacturer products View details

Aiforia® Clinical Suite Viewer

Aiforia® Clinical Suite Viewer

IVD Class CIVDR 2017/746On the marketDirect markingProfessional testing

Manufacturer: Aiforia Technologies Plc
Manufacturer SRN: FI-MF-000008986
UDI-DI: 06429810612168
Basic UDI-DI: 06429810612SU001RQ
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: 30.07.2026 18:51

Manufacturer products View details

Aiforia® Lymph Node Metastasis

Aiforia® Lymph Node Metastasis

IVD Class CIVDR 2017/746On the marketDirect markingProfessional testing

Manufacturer: Aiforia Technologies Plc
Manufacturer SRN: FI-MF-000008986
UDI-DI: 06429810612137
Basic UDI-DI: 06429810612LN001MS
Reference: Aiforia® Lymph Node Metastasis
EMDN: W0202050392
EMDN description: LABORATORY INSTRUMENTS FOR MICROSCOPIC INVESTIGATIONS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Finland
Authorised representative: -
Last updated: 30.07.2026 18:51

Manufacturer products View details

Aiforia® Gastric Cancer

Aiforia® Gastric Cancer

IVD Class CIVDR 2017/746On the marketDirect markingProfessional testing

Manufacturer: Aiforia Technologies Plc
Manufacturer SRN: FI-MF-000008986
UDI-DI: 06429810612120
Basic UDI-DI: 06429810612GA001H8
Reference: Aiforia® Gastric Cancer
EMDN: W0202050392
EMDN description: LABORATORY INSTRUMENTS FOR MICROSCOPIC INVESTIGATIONS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Finland
Authorised representative: -
Last updated: 30.07.2026 18:51

Manufacturer products View details

Aiforia® Breast Cancer Grading

Aiforia® Breast Cancer Grading

IVD Class CIVDR 2017/746On the marketDirect markingProfessional testing

Manufacturer: Aiforia Technologies Plc
Manufacturer SRN: FI-MF-000008986
UDI-DI: 06429810612113
Basic UDI-DI: 06429810612BR005KG
Reference: Aiforia® Breast Cancer Grading
EMDN: W0202050392
EMDN description: LABORATORY INSTRUMENTS FOR MICROSCOPIC INVESTIGATIONS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Finland
Authorised representative: -
Last updated: 30.07.2026 18:51

Manufacturer products View details

Aiforia® Clinical AI Model for Breast Cancer - HER2

Aiforia® Clinical AI Model for Breast Cancer - HER2

IVD Class CIVDR 2017/746On the marketDirect markingProfessional testing

Manufacturer: Aiforia Technologies Plc
Manufacturer SRN: FI-MF-000008986
UDI-DI: 06429810612076
Basic UDI-DI: 06429810612BR004KE
Reference: Aiforia® Clinical AI Model for Breast Cancer - HER2
EMDN: W0202050392
EMDN description: LABORATORY INSTRUMENTS FOR MICROSCOPIC INVESTIGATIONS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Finland
Authorised representative: -
Last updated: 30.07.2026 18:51

Manufacturer products View details

Digital Pathology System - aetherSlide

aetherSlide

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testing

Manufacturer: aetherAI Co., Ltd.
Manufacturer SRN: TW-MF-000038521
UDI-DI: 04719884160118
Basic UDI-DI: 04719884160112B
Reference: aetherSlide
EMDN: W0202050392
EMDN description: LABORATORY INSTRUMENTS FOR MICROSCOPIC INVESTIGATIONS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 30.07.2026 18:43

Manufacturer products Authorised representative products Authorised representative actors View details