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Reagent Containers

CY012-C01-02

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentKitProfessional testingSingle use

Manufacturer: Cypress Diagnostics
Manufacturer SRN: BE-MF-000000033
UDI-DI: 05404035100424
Basic UDI-DI: 54040351CY012-CT7
Reference: CY012-C02
EMDN: W0202020185
EMDN description: COAGULOMETERS - CONSUMABLES
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 10:50

Manufacturer products View details

Cuvettes and balls for 500 tests

CY003

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testingSingle use

Manufacturer: Cypress Diagnostics
Manufacturer SRN: BE-MF-000000033
UDI-DI: 05404035100387
Basic UDI-DI: 54040351CY0035Q
Reference: CY003-C01
EMDN: W0202020185
EMDN description: COAGULOMETERS - CONSUMABLES
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 10:50

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

Cuvettes and balls for 1000 tests

CY012-C01-02

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentKitProfessional testingSingle use

Manufacturer: Cypress Diagnostics
Manufacturer SRN: BE-MF-000000033
UDI-DI: 05404035100394
Basic UDI-DI: 54040351CY012-CT7
Reference: CY012-C01
EMDN: W0202020185
EMDN description: COAGULOMETERS - CONSUMABLES
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 10:46

Manufacturer products View details

CYANCoag 1Ch

CY003

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Cypress Diagnostics
Manufacturer SRN: BE-MF-000000033
UDI-DI: 05404035100318
Basic UDI-DI: 54040351CY0035Q
Reference: CY003
EMDN: W0202020101
EMDN description: SEMI-AUTOMATED COAGULOMETERS
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 10:46

Manufacturer products View details

TruCell

IVD Class ANot specifiedOn the market

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763914
Basic UDI-DI: 5065023763TC60001TV
Reference: TC60001
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Czechia
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 09:36

Manufacturer products Authorised representative products Authorised representative actors View details

TruHemo

IVD Class ANot specifiedOn the market

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763891
Basic UDI-DI: 5065023763TH10001U7
Reference: TH10001
EMDN: W0202020102
EMDN description: AUTOMATED COAGULOMETERS
First on market country: Ireland
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 09:22

Manufacturer products Authorised representative products Authorised representative actors View details

TruCell

TC100

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

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763846
Basic UDI-DI: 5065023763TC100R8
Reference: TC10001
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: France
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 09:22

Manufacturer products Authorised representative products Authorised representative actors 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

Hb Hemoglobin Test Meter

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

Manufacturer: Rapid Labs Ltd
Manufacturer SRN: GB-MF-000026335
UDI-DI: 05060599403311
Basic UDI-DI: 5060599400002SNZ
Reference: RL-HBM-1A
EMDN: W02020699
EMDN description: RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER
First on market country: Spain
Authorised representative: VidaQuick Biotech S.L.
Last updated: 31.07.2026 08:48

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