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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

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

SUPA MEGA MOTHERSHIP – YELLOW

SUPA MEGA MOTHERSHIP CASSETTE

IVD Class AIVDR 2017/746On the marketInstrumentSingle use

Manufacturer: CellPath Ltd
Manufacturer SRN: GB-MF-000022744
UDI-DI: 05056256124101
Basic UDI-DI: 05056256EAO001Z4
Reference: EAO-0109-02A
EMDN: W0202050385
EMDN description: LABORATORY INSTRUMENTS FOR MICROSCOPIC INVESTIGATIONS - CONSUMABLES
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 30.07.2026 18:45

Manufacturer products Authorised representative products Authorised representative actors View details

170 MICRON BIOPSY BAG 75mm x 45mm - POLYESTER ACID RESISTANT

BIOPSY BAGS

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsSingle use

Manufacturer: CellPath Ltd
Manufacturer SRN: GB-MF-000022744
UDI-DI: 05056256124088
Basic UDI-DI: 05056256EBF001XG
Reference: EBF-0300-10A
EMDN: W0202050385
EMDN description: LABORATORY INSTRUMENTS FOR MICROSCOPIC INVESTIGATIONS - CONSUMABLES
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 30.07.2026 18:45

Manufacturer products Authorised representative products Authorised representative actors View details

CELLSAFE+ BIOPSY CAPSULE - WHITE

CELLSAFE+

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testingSingle use

Manufacturer: CellPath Ltd
Manufacturer SRN: GB-MF-000022744
UDI-DI: 05056256123876
Basic UDI-DI: 05056256EBE001X9
Reference: EBE-0201-02A
EMDN: W0202050385
EMDN description: LABORATORY INSTRUMENTS FOR MICROSCOPIC INVESTIGATIONS - CONSUMABLES
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 30.07.2026 18:45

Manufacturer products Authorised representative products Authorised representative actors View details

BIOPAD BIOPSY PAD - BLACK

BIOPAD BIOPSY PAD

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testingSingle use

Manufacturer: CellPath Ltd
Manufacturer SRN: GB-MF-000022744
UDI-DI: 05056256123838
Basic UDI-DI: 05056256EBA001WD
Reference: EBA-0101-03A
EMDN: W0202050385
EMDN description: LABORATORY INSTRUMENTS FOR MICROSCOPIC INVESTIGATIONS - CONSUMABLES
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 30.07.2026 18:45

Manufacturer products Authorised representative products Authorised representative actors View details

STAINLESS STEEL BASE MOULD 7x7x5mm

STAINLESS STEEL BASE MOULD

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: CellPath Ltd
Manufacturer SRN: GB-MF-000022744
UDI-DI: 05056256123296
Basic UDI-DI: 05056256GBZ0014R
Reference: GBB-0714-05A
EMDN: W0202050385
EMDN description: LABORATORY INSTRUMENTS FOR MICROSCOPIC INVESTIGATIONS - CONSUMABLES
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 30.07.2026 18:45

Manufacturer products Authorised representative products Authorised representative actors View details

4 INCH (100mm) CARTILAGE KNIFE

Macro Knives

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: CellPath Ltd
Manufacturer SRN: GB-MF-000022744
UDI-DI: 05056256121285
Basic UDI-DI: 05056256CAA001V8
Reference: CAA-0401-01A
EMDN: W0202050385
EMDN description: LABORATORY INSTRUMENTS FOR MICROSCOPIC INVESTIGATIONS - CONSUMABLES
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 30.07.2026 18:45

Manufacturer products Authorised representative products Authorised representative actors View details

SYSTEM II+ 2 WELL CASSETTE - WHITE (LOOSE)

SYSTEM II+ MULTIWELL

IVD Class AIVDR 2017/746On the marketInstrumentSingle use

Manufacturer: CellPath Ltd
Manufacturer SRN: GB-MF-000022744
UDI-DI: 05056256119435
Basic UDI-DI: 05056256EAM003YS
Reference: EAM-1702-03A
EMDN: W0202050385
EMDN description: LABORATORY INSTRUMENTS FOR MICROSCOPIC INVESTIGATIONS - CONSUMABLES
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 30.07.2026 18:45

Manufacturer products Authorised representative products Authorised representative actors View details

TRUSLICE DIGITAL – SPECIMEN CUT UP SYSTEM

TRUSLICE DIGITAL

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: CellPath Ltd
Manufacturer SRN: GB-MF-000022744
UDI-DI: 05056256119428
Basic UDI-DI: 05056256CBA002VM
Reference: CBA-0200-00A
EMDN: W0202050385
EMDN description: LABORATORY INSTRUMENTS FOR MICROSCOPIC INVESTIGATIONS - CONSUMABLES
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 30.07.2026 18:45

Manufacturer products Authorised representative products Authorised representative actors View details

CELLSAFE I BIOPSY CASSETTE - WHITE LASER (THREADED)

CELLSAFE I

IVD Class AIVDR 2017/746On the marketHuman tissuesInstrumentSingle use

Manufacturer: CellPath Ltd
Manufacturer SRN: GB-MF-000022744
UDI-DI: 05056256114799
Basic UDI-DI: 05056256EBG002XR
Reference: EBG-0402-03B
EMDN: W0202050385
EMDN description: LABORATORY INSTRUMENTS FOR MICROSCOPIC INVESTIGATIONS - CONSUMABLES
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 30.07.2026 18:45

Manufacturer products Authorised representative products Authorised representative actors View details

SYSTEM II HEX - CASSETTE - WHITE (LOOSE)

SYSTEM II HEX

IVD Class AIVDR 2017/746On the marketInstrumentSingle use

Manufacturer: CellPath Ltd
Manufacturer SRN: GB-MF-000022744
UDI-DI: 05056256113709
Basic UDI-DI: 05056256EAD001WP
Reference: EAD-0102-03A
EMDN: W0202050385
EMDN description: LABORATORY INSTRUMENTS FOR MICROSCOPIC INVESTIGATIONS - CONSUMABLES
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 30.07.2026 18:44

Manufacturer products Authorised representative products Authorised representative actors View details

SYSTEM III BIOPSY CASSETTE - WHITE (LOOSE INKJET)

SYSTEM III CASSETTE

IVD Class AIVDR 2017/746No longer on the marketInstrumentSingle use

Manufacturer: CellPath Ltd
Manufacturer SRN: GB-MF-000022744
UDI-DI: 05056256113341
Basic UDI-DI: 05056256EAI001XS
Reference: EAI-0302-10A
EMDN: W0202050385
EMDN description: LABORATORY INSTRUMENTS FOR MICROSCOPIC INVESTIGATIONS - CONSUMABLES
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 30.07.2026 18:44

Manufacturer products Authorised representative products Authorised representative actors View details

SUPA MEGA SLIM CASSETTE - WHITE

SUPA MEGA SLIM CASSETTE

IVD Class AIVDR 2017/746On the marketInstrumentSingle use

Manufacturer: CellPath Ltd
Manufacturer SRN: GB-MF-000022744
UDI-DI: 05056256113235
Basic UDI-DI: 05056256EAN001YV
Reference: EAN-0102-02A
EMDN: W0202050385
EMDN description: LABORATORY INSTRUMENTS FOR MICROSCOPIC INVESTIGATIONS - CONSUMABLES
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 30.07.2026 18:44

Manufacturer products Authorised representative products Authorised representative actors View details

SYSTEM II+ SLOTTED CASSETTE - BLUE (LOOSE)

System II+

IVD Class AIVDR 2017/746On the marketSingle use

Manufacturer: CellPath Ltd
Manufacturer SRN: GB-MF-000022744
UDI-DI: 05056256111330
Basic UDI-DI: 05056256EAM002YQ
Reference: EAM-0506-03A
EMDN: W0202050385
EMDN description: LABORATORY INSTRUMENTS FOR MICROSCOPIC INVESTIGATIONS - CONSUMABLES
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 30.07.2026 18:44

Manufacturer products Authorised representative products Authorised representative actors View details

PathFlow PiSmart Thermal Cassettes Slotted White

HISTOLOGY TISSUE CASSETTES

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: CellPath Ltd
Manufacturer SRN: GB-MF-000022744
UDI-DI: 05056256107753
Basic UDI-DI: 050562561HTC001UX
Reference: EAM-0202-72B
EMDN: W0202050385
EMDN description: LABORATORY INSTRUMENTS FOR MICROSCOPIC INVESTIGATIONS - CONSUMABLES
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 30.07.2026 18:44

Manufacturer products Authorised representative products Authorised representative actors 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

SurePath

BD SurePath PreCoat Slides

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Becton, Dickinson and Company
Manufacturer SRN: US-MF-000018910
UDI-DI: 30382904912483
Basic UDI-DI: 038290MJZIOXBDJ7
Reference: 491248
EMDN: W0202050385
EMDN description: LABORATORY INSTRUMENTS FOR MICROSCOPIC INVESTIGATIONS - CONSUMABLES
First on market country: Belgium
Authorised representative: Becton Dickinson Ireland Limited
Last updated: 30.07.2026 18:31

Manufacturer products Authorised representative products Authorised representative actors View details

PrepMate

BD Totalys MultiProcessorConsumables Kit BD SurePath Manual Method Kit BD PrepMate Consumables Kit BD PrepStain Consumables Kit BD Totalys SlidePrep Consumables Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Becton, Dickinson and Company
Manufacturer SRN: US-MF-000018910
UDI-DI: 00382904914554
Basic UDI-DI: 038290FXHRELFOE9
Reference: 491455
EMDN: W0202050385
EMDN description: LABORATORY INSTRUMENTS FOR MICROSCOPIC INVESTIGATIONS - CONSUMABLES
First on market country: Belgium
Authorised representative: Becton Dickinson Ireland Limited
Last updated: 30.07.2026 18:23

Manufacturer products Authorised representative products Authorised representative actors View details

SYSTEM II+ SLOTTED CASSETTE - BLUE (HOPPERED)

IVD Class ANot specifiedOn the marketSingle use

Manufacturer: CellPath Ltd
Manufacturer SRN: GB-MF-000022744
UDI-DI: 05056256111347
Basic UDI-DI: 05056256EAM002YQ
Reference: EAM-0506-05H
EMDN: W0202050385
EMDN description: LABORATORY INSTRUMENTS FOR MICROSCOPIC INVESTIGATIONS - CONSUMABLES
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 30.07.2026 01:59

Manufacturer products Authorised representative products Authorised representative actors View details