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User-Fillable Reagent Bottle 50mL Capacity (Link)

SK203

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Agilent Technologies, Inc.
Manufacturer SRN: US-MF-000009385
UDI-DI: 05700571104873
Basic UDI-DI: 570057P3007P3010A056201P5
Reference: SK203
EMDN: W0202059085
EMDN description: VARIOUS PROCESSING INSTRUMENTS FOR HYSTOLOGY / CYTOLOGY - CONSUMABLES
First on market country: Denmark
Authorised representative: Agilent Technologies Denmark ApS
Last updated: 31.07.2026 11:50

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User-Fillable Reagent Bottle 25mL Capacity (Link)

SK202

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Agilent Technologies, Inc.
Manufacturer SRN: US-MF-000009385
UDI-DI: 05700571104866
Basic UDI-DI: 570057P3007P3010A056101NY
Reference: SK202
EMDN: W0202059085
EMDN description: VARIOUS PROCESSING INSTRUMENTS FOR HYSTOLOGY / CYTOLOGY - CONSUMABLES
First on market country: Denmark
Authorised representative: Agilent Technologies Denmark ApS
Last updated: 31.07.2026 11:50

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User-Fillable Reagent Bottle 12mL Capacity (Link)

SK201

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Agilent Technologies, Inc.
Manufacturer SRN: US-MF-000009385
UDI-DI: 05700571104859
Basic UDI-DI: 570057P3007P3010A056001NT
Reference: SK201
EMDN: W0202059085
EMDN description: VARIOUS PROCESSING INSTRUMENTS FOR HYSTOLOGY / CYTOLOGY - CONSUMABLES
First on market country: Denmark
Authorised representative: Agilent Technologies Denmark ApS
Last updated: 31.07.2026 11:50

Manufacturer products Authorised representative products Authorised representative actors View details

User Fillable Reagent Bottle 5mL Capacity (Link)

SK200

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Agilent Technologies, Inc.
Manufacturer SRN: US-MF-000009385
UDI-DI: 05700571104842
Basic UDI-DI: 570057P3007P3010A055901PZ
Reference: SK200
EMDN: W0202059085
EMDN description: VARIOUS PROCESSING INSTRUMENTS FOR HYSTOLOGY / CYTOLOGY - CONSUMABLES
First on market country: Denmark
Authorised representative: Agilent Technologies Denmark ApS
Last updated: 31.07.2026 11:50

Manufacturer products Authorised representative products Authorised representative actors View details

Barco

Pathology Display

IVD Class AIVDR 2017/746On the market

Manufacturer: Barco NV
Manufacturer SRN: BE-MF-000000690
UDI-DI: 05415334055926
Basic UDI-DI: 5415334_Patho-IVD_VT
Reference: K9301101A2X
EMDN: W0202050380
EMDN description: LABORATORY INSTRUMENTS FOR MICROSCOPIC INVESTIGATIONS - HARDWARE ACCESSORIES
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:01

Manufacturer products View details

Smartcolor

AQUAREL-1P

IVD Class AIVDR 2017/746On the marketDirect markingInstrument

Manufacturer: SIDENA
Manufacturer SRN: FR-MF-000021700
UDI-DI: 05419980256140
Basic UDI-DI: 54199802561AQ1PZA
Reference: AQUAREL-502
EMDN: W0202059002
EMDN description: AUTOMATED SLIDE STAINERS
First on market country: France
Authorised representative: -
Last updated: 31.07.2026 10:54

Manufacturer products View details

Barco

Pathology Display

IVD Class AIVDR 2017/746On the market

Manufacturer: Barco NV
Manufacturer SRN: BE-MF-000000690
UDI-DI: 05415334055919
Basic UDI-DI: 5415334_Patho-IVD_VT
Reference: K9301100A2X
EMDN: W0202050380
EMDN description: LABORATORY INSTRUMENTS FOR MICROSCOPIC INVESTIGATIONS - HARDWARE ACCESSORIES
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 10:54

Manufacturer products View details

Histolog Scanner Gen III

008

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: SamanTree Medical SA
Manufacturer SRN: BE-MF-000048313
UDI-DI: 05407012840085
Basic UDI-DI: 5407012840086H
Reference: 008
EMDN: W0202050302
EMDN description: LASER SCANNING MICROSCOPES
First on market country: Poland
Authorised representative: -
Last updated: 31.07.2026 10:47

Manufacturer products View details

Glissando RS2

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Objective Imaging Ltd
Manufacturer SRN: GB-MF-000016742
UDI-DI: 05060905850082
Basic UDI-DI: 506090585AAA003S7
Reference: GLISS-RS2-IVD
EMDN: W0202050304
EMDN description: DIGITAL LABORATORY MICROSCOPES
First on market country: Ireland
Authorised representative: Acorn Regulatory Consultancy Services Ltd
Last updated: 31.07.2026 08:56

Manufacturer products Authorised representative products Authorised representative actors View details

Glissando RS20

A002HR-RS20-IVD

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Objective Imaging Ltd
Manufacturer SRN: GB-MF-000016742
UDI-DI: 05060905850068
Basic UDI-DI: 506090585AAA002S5
Reference: GLISS-RS20-IVD
EMDN: W0202050304
EMDN description: DIGITAL LABORATORY MICROSCOPES
First on market country: Ireland
Authorised representative: Acorn Regulatory Consultancy Services Ltd
Last updated: 31.07.2026 08:56

Manufacturer products Authorised representative products Authorised representative actors View details

Glissando 20SL

A002HR20SL-40-OBJ

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Objective Imaging Ltd
Manufacturer SRN: GB-MF-000016742
UDI-DI: 05060905850037
Basic UDI-DI: 506090585AAA001S3
Reference: GLISS-20SL-40X-IVD
EMDN: W0202050304
EMDN description: DIGITAL LABORATORY MICROSCOPES
First on market country: Ireland
Authorised representative: Acorn Regulatory Consultancy Services Ltd
Last updated: 31.07.2026 08:56

Manufacturer products Authorised representative products Authorised representative actors View details

Glissando Desktop Scanner

A002HR-40-OBJ

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Objective Imaging Ltd
Manufacturer SRN: GB-MF-000016742
UDI-DI: 05060905850006
Basic UDI-DI: 506090585AAA000RZ
Reference: GLISSR2-40X-IVD
EMDN: W0202050304
EMDN description: DIGITAL LABORATORY MICROSCOPES
First on market country: Ireland
Authorised representative: Acorn Regulatory Consultancy Services Ltd
Last updated: 31.07.2026 08:56

Manufacturer products Authorised representative products Authorised representative actors View details

Shandon™ PapSpin™

Liquid-based Cytology Preparation System

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Shandon Diagnostics Limited
Manufacturer SRN: GB-MF-000008187
UDI-DI: 05051663503495
Basic UDI-DI: 5051663SDL013K9
Reference: A78710006
EMDN: W02020502
EMDN description: CERVICAL SCREENING SYSTEMS
First on market country: Netherlands
Authorised representative: Epredia Netherlands B.V.
Last updated: 31.07.2026 08:04

Manufacturer products Authorised representative products Authorised representative actors View details

HM525 NX HC

HM525 NX Cryostat

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Shandon Diagnostics Limited
Manufacturer SRN: GB-MF-000008187
UDI-DI: 05051663011433
Basic UDI-DI: 5051663SDL014KB
Reference: 956650EC70
EMDN: W0202059003
EMDN description: CRYOSTAT MICROTOMES
First on market country: Netherlands
Authorised representative: Epredia Netherlands B.V.
Last updated: 31.07.2026 08:04

Manufacturer products Authorised representative products Authorised representative actors View details

Epredia E1000 Dx Digital Pathology Solution

E1000 Dx Digital Pathology Solution

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Shandon Diagnostics Limited
Manufacturer SRN: GB-MF-000008187
UDI-DI: 05051663010467
Basic UDI-DI: 5051663SDL025KG
Reference: A85200002
EMDN: W0202050304
EMDN description: DIGITAL LABORATORY MICROSCOPES
First on market country: Netherlands
Authorised representative: Epredia Netherlands B.V.
Last updated: 31.07.2026 08:04

Manufacturer products Authorised representative products Authorised representative actors View details

HM 450

HM 450 Sliding Microtome

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Shandon Diagnostics Limited
Manufacturer SRN: GB-MF-000008187
UDI-DI: 05051663010115
Basic UDI-DI: 5051663SDL021K8
Reference: 910020
EMDN: W0202059005
EMDN description: MICROTOMES
First on market country: Netherlands
Authorised representative: Epredia Netherlands B.V.
Last updated: 31.07.2026 08:04

Manufacturer products Authorised representative products Authorised representative actors View details

LINISTAT

LINISTAT Slide Stainer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Shandon Diagnostics Limited
Manufacturer SRN: GB-MF-000008187
UDI-DI: 05051663010016
Basic UDI-DI: 5051663SDL008KG
Reference: B1000200
EMDN: W0202059002
EMDN description: AUTOMATED SLIDE STAINERS
First on market country: Netherlands
Authorised representative: Epredia Netherlands B.V.
Last updated: 31.07.2026 08:04

Manufacturer products Authorised representative products Authorised representative actors View details

Revos

Revos Tissue Processor

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Shandon Diagnostics Limited
Manufacturer SRN: GB-MF-000008187
UDI-DI: 05051663009966
Basic UDI-DI: 5051663SDL001K2
Reference: A84100001
EMDN: W0202059010
EMDN description: TISSUE PROCESSORS
First on market country: Netherlands
Authorised representative: Epredia Netherlands B.V.
Last updated: 31.07.2026 08:04

Manufacturer products Authorised representative products Authorised representative actors View details

CTM6

CTM6 Coverslipper

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Shandon Diagnostics Limited
Manufacturer SRN: GB-MF-000008187
UDI-DI: 05051663009768
Basic UDI-DI: 5051663SDL011K5
Reference: 970010
EMDN: W0202059008
EMDN description: AUTOMATED COVERSLIPPERS
First on market country: Netherlands
Authorised representative: Epredia Netherlands B.V.
Last updated: 31.07.2026 08:04

Manufacturer products Authorised representative products Authorised representative actors View details

Excelsior AS

Excelsior AS Tissue Processor

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Shandon Diagnostics Limited
Manufacturer SRN: GB-MF-000008187
UDI-DI: 05051663009737
Basic UDI-DI: 5051663SDL002K4
Reference: A82300001
EMDN: W0202059010
EMDN description: TISSUE PROCESSORS
First on market country: Netherlands
Authorised representative: Epredia Netherlands B.V.
Last updated: 31.07.2026 08:04

Manufacturer products Authorised representative products Authorised representative actors View details