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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® Prostate Cancer PNI

Aiforia® Prostate Cancer PNI

IVD Class CIVDR 2017/746On 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: 30.07.2026 18:51

Manufacturer products View details

Aiforia® Prostate Cancer G4 Cribriform

Aiforia® Prostate Cancer G4 Cribriform

IVD Class CIVDR 2017/746On 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: 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

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