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Automated Stainer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Guangzhou Naturn Medical Devices Co., Ltd.
Manufacturer SRN: CN-MF-000042263
UDI-DI: 06977568270142
Basic UDI-DI: 697756827AS7G
Reference: ST510
EMDN: W0202059002
EMDN description: AUTOMATED SLIDE STAINERS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 07.08.2026 02:45

Manufacturer products Authorised representative products Authorised representative actors View details

Automated Coverslipper

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Guangzhou Naturn Medical Devices Co., Ltd.
Manufacturer SRN: CN-MF-000042263
UDI-DI: 06977568271163
Basic UDI-DI: 697756827004R9
Reference: CV610S
EMDN: W0202059008
EMDN description: AUTOMATED COVERSLIPPERS
First on market country: -
Authorised representative: MedPath GmbH
Last updated: 06.08.2026 22:54

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

Tissue-Tek Genie® Controller System

Tissue-Tek Genie® Accessories (Auxiliary Products)

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Sakura Finetek USA, Inc
Manufacturer SRN: US-MF-000022208
UDI-DI: 00615233002907
Basic UDI-DI: 06152338226JA
Reference: 0008008-01
EMDN: W0202059002
EMDN description: AUTOMATED SLIDE STAINERS
First on market country: Netherlands
Authorised representative: Sakura Finetek Europe B.V.
Last updated: 05.08.2026 15:38

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

HistoCore PELORIS 3 (220-240V) Laboratory - Tissue Processor

HistoCore PELORIS

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Leica Biosystems Melbourne Pty Ltd
Manufacturer SRN: AU-MF-000016740
UDI-DI: 09349458005696
Basic UDI-DI: 9349458002DB
Reference: RS45.0001
EMDN: W0202059010
EMDN description: TISSUE PROCESSORS
First on market country: Netherlands
Authorised representative: CEpartner4U
Last updated: 04.08.2026 22:59

Manufacturer products Authorised representative products Authorised representative actors View details

Zebra ZD421 Label Printer Spare

IVD Class ANot specifiedOn the market

Manufacturer: Leica Biosystems Melbourne Pty Ltd
Manufacturer SRN: AU-MF-000016740
UDI-DI: 09349458005627
Basic UDI-DI: 9349458001D9
Reference: S21.4632
EMDN: W0202059002
EMDN description: AUTOMATED SLIDE STAINERS
First on market country: Netherlands
Authorised representative: CEpartner4U
Last updated: 04.08.2026 22:58

Manufacturer products Authorised representative products Authorised representative actors View details

BOND-ADVANCE Terminal (6.0/W10 loT)

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Leica Biosystems Melbourne Pty Ltd
Manufacturer SRN: AU-MF-000016740
UDI-DI: 09349458005467
Basic UDI-DI: 9349458001D9
Reference: S21.4622
EMDN: W0202059002
EMDN description: AUTOMATED SLIDE STAINERS
First on market country: -
Authorised representative: CEpartner4U
Last updated: 04.08.2026 22:52

Manufacturer products Authorised representative products Authorised representative actors View details

BOND Controller (6.0/W10 loT)

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Leica Biosystems Melbourne Pty Ltd
Manufacturer SRN: AU-MF-000016740
UDI-DI: 09349458004859
Basic UDI-DI: 9349458001D9
Reference: S21.4621
EMDN: W0202059002
EMDN description: AUTOMATED SLIDE STAINERS
First on market country: -
Authorised representative: CEpartner4U
Last updated: 04.08.2026 22:52

Manufacturer products Authorised representative products Authorised representative actors View details

TintoStainer Plus LX Automated System

BSB-7400-60

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Shenzhen Dartmon Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000019183
UDI-DI: 06927210914672
Basic UDI-DI: 697550352BSB7400LXYU
Reference: BSB-7400-60
EMDN: W0202059002
EMDN description: AUTOMATED SLIDE STAINERS
First on market country: Greece
Authorised representative: Umedwings Netherlands B.V.
Last updated: 04.08.2026 22:22

Manufacturer products Authorised representative products Authorised representative actors View details

TintoStainer Plus Mini Automated System

BSB-7400-10

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Shenzhen Dartmon Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000019183
UDI-DI: 06927210914665
Basic UDI-DI: 697550352BSB7400MINI2G
Reference: BSB-7400-10
EMDN: W0202059002
EMDN description: AUTOMATED SLIDE STAINERS
First on market country: Greece
Authorised representative: Umedwings Netherlands B.V.
Last updated: 04.08.2026 22:22

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: 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

miLab™ Cartridge CER

CCEA

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Noul Co., Ltd.
Manufacturer SRN: KR-MF-000033621
UDI-DI: 18800100110215
Basic UDI-DI: B-18800100110215
Reference: CCEA
EMDN: W02020502
EMDN description: CERVICAL SCREENING SYSTEMS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 04.08.2026 19:16

Manufacturer products Authorised representative products Authorised representative actors View details

Printer Ribbon & Labels Cxi (1 Pack)

IVD Class ANot specifiedOn the market

Manufacturer: Leica Biosystems Melbourne Pty Ltd
Manufacturer SRN: AU-MF-000016740
UDI-DI: 09349458005634
Basic UDI-DI: 9349458001D9
Reference: S21.4604
EMDN: W0202059002
EMDN description: AUTOMATED SLIDE STAINERS
First on market country: -
Authorised representative: CEpartner4U
Last updated: 04.08.2026 08:18

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