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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

05999888051608

13500

Class IIaMDDOn the marketActive device

Manufacturer: Newmars Technologies kft
Manufacturer SRN: HU-MF-000007115
UDI-DI: 05999888051608
Basic UDI-DI: B-05999888051608
Reference: 13500
EMDN: W02020502
EMDN description: CERVICAL SCREENING SYSTEMS
First on market country: Hungary
Authorised representative: -
Last updated: 03.08.2026 03:25

Manufacturer products View details

ExSeed Home Sperm Test Kit

ExSeed Home Sperm Test Kit (5)

IVD self-testing devicesIVDDOn the marketKitNear-patient testingSelf testingSingle use

Manufacturer: ExSeed Health ApS
Manufacturer SRN: DK-MF-000025034
UDI-DI: 05745000659036
Basic UDI-DI: B-05745000659036
Reference: EH-1001-05
EMDN: W02020199
EMDN description: CELL COUNTING INSTRUMENTS - OTHER
First on market country: Denmark
Authorised representative: -
Last updated: 02.08.2026 22:56

Manufacturer products View details

ExSeed Home Sperm Test Kit

ExSeed Home Sperm Test Kit (2)

IVD self-testing devicesIVDDOn the marketKitSelf testingSingle use

Manufacturer: ExSeed Health ApS
Manufacturer SRN: DK-MF-000025034
UDI-DI: 05745000659029
Basic UDI-DI: B-05745000659029
Reference: EH-1001-01
EMDN: W02020199
EMDN description: CELL COUNTING INSTRUMENTS - OTHER
First on market country: Denmark
Authorised representative: -
Last updated: 02.08.2026 22:56

Manufacturer products View details

CYANHemato 380

CY017

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: Cypress Diagnostics
Manufacturer SRN: BE-MF-000000033
UDI-DI: 05404035100486
Basic UDI-DI: B-05404035100486
Reference: CY017
EMDN: W0202010201
EMDN description: AUTOMATED 3 PART HEMATOLOGY ANALYSERS
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 20:34

Manufacturer products View details

04980679064625

Smart Rate 40

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: JOKOH CO.,LTD.
Manufacturer SRN: JP-MF-000025161
UDI-DI: 04980679064625
Basic UDI-DI: B-04980679064625
Reference: J06462
EMDN: W02029001
EMDN description: ERYTHROCYTE SEDIMENTATION RATE DEVICES
First on market country: Greece
Authorised representative: MDSS GmbH
Last updated: 02.08.2026 14:26

Manufacturer products Authorised representative products Authorised representative actors View details

04980679064618

Smart Rate 20

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: JOKOH CO.,LTD.
Manufacturer SRN: JP-MF-000025161
UDI-DI: 04980679064618
Basic UDI-DI: B-04980679064618
Reference: J06461
EMDN: W02029001
EMDN description: ERYTHROCYTE SEDIMENTATION RATE DEVICES
First on market country: Greece
Authorised representative: MDSS GmbH
Last updated: 02.08.2026 14:26

Manufacturer products Authorised representative products Authorised representative actors View details

04980679064601

Smart Rate 10

IVD generalIVDDOn the marketInstrumentNear-patient testingProfessional testing

Manufacturer: JOKOH CO.,LTD.
Manufacturer SRN: JP-MF-000025161
UDI-DI: 04980679064601
Basic UDI-DI: B-04980679064601
Reference: J06460
EMDN: W02029001
EMDN description: ERYTHROCYTE SEDIMENTATION RATE DEVICES
First on market country: Lithuania
Authorised representative: MDSS GmbH
Last updated: 02.08.2026 14:26

Manufacturer products Authorised representative products Authorised representative actors View details

Bone Marrow Smear Analysis Software - aetherAI Hema

aetherAI Hema

IVD generalIVDDOn the marketProfessional testing

Manufacturer: aetherAI Co., Ltd.
Manufacturer SRN: TW-MF-000038521
UDI-DI: 04719884160323
Basic UDI-DI: B-04719884160323
Reference: aetherAI Hema
EMDN: W0202010292
EMDN description: LIMITED PANEL CELL COUNTING ANALYSERS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.08.2026 13:58

Manufacturer products Authorised representative products Authorised representative actors View details

Printer Ribbon & Labels Cxi (6 Pack)

IVD Class ANot specifiedOn the market

Manufacturer: Leica Biosystems Melbourne Pty Ltd
Manufacturer SRN: AU-MF-000016740
UDI-DI: 09349458005641
Basic UDI-DI: 9349458001D9
Reference: S21.4610
EMDN: W0202059002
EMDN description: AUTOMATED SLIDE STAINERS
First on market country: -
Authorised representative: CEpartner4U
Last updated: 02.08.2026 09:05

Manufacturer products Authorised representative products Authorised representative actors View details

Grossing Station TST1200

TST1200

IVD Class AIVDR 2017/746On the market

Manufacturer: AMOS SCIENTIFIC PTY.,LTD
Manufacturer SRN: AU-MF-000036895
UDI-DI: 09309001291198
Basic UDI-DI: 9309001291198YB
Reference: TST1200
EMDN: W0202059011
EMDN description: SAMPLE PREPARATION UNITS FOR CHROMOSOMIC ANALYSIS
First on market country: Romania
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 01.08.2026 00:43

Manufacturer products Authorised representative products Authorised representative actors View details

Thermal Console TEC2800-T

TEC2800-T

IVD Class AIVDR 2017/746On the market

Manufacturer: AMOS SCIENTIFIC PTY.,LTD
Manufacturer SRN: AU-MF-000036895
UDI-DI: 09309001291037
Basic UDI-DI: 9309001291037XJ
Reference: TEC2800-T
EMDN: W0202059009
EMDN description: PARAFFIN DISPENSERS
First on market country: Romania
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 01.08.2026 00:43

Manufacturer products Authorised representative products Authorised representative actors View details

Cryo Console TEC2800-C

TEC2800-C

IVD Class AIVDR 2017/746On the market

Manufacturer: AMOS SCIENTIFIC PTY.,LTD
Manufacturer SRN: AU-MF-000036895
UDI-DI: 09309001291020
Basic UDI-DI: 9309001291020WZ
Reference: TEC2800-C
EMDN: W0202059012
EMDN description: COOLING PARAFFIN PLATES
First on market country: Romania
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 01.08.2026 00:43

Manufacturer products Authorised representative products Authorised representative actors View details

Embedding Center TEC2800-M

TEC2800-M

IVD Class AIVDR 2017/746On the market

Manufacturer: AMOS SCIENTIFIC PTY.,LTD
Manufacturer SRN: AU-MF-000036895
UDI-DI: 09309001291013
Basic UDI-DI: 9309001291013X4
Reference: TEC2800-M
EMDN: W0202059004
EMDN description: TISSUE EMBEDDING PROCESSORS
First on market country: Romania
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 01.08.2026 00:43

Manufacturer products Authorised representative products Authorised representative actors View details

Tissue Processor ATP140

ATP140

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: AMOS SCIENTIFIC PTY.,LTD
Manufacturer SRN: AU-MF-000036895
UDI-DI: 09309001291006
Basic UDI-DI: 9309001291006X7
Reference: ATP140
EMDN: W0202059010
EMDN description: TISSUE PROCESSORS
First on market country: Romania
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 01.08.2026 00:43

Manufacturer products Authorised representative products Authorised representative actors View details

09120036864146

Ceveron 100 series Cuvettes

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH
Manufacturer SRN: AT-MF-000024115
UDI-DI: 09120036864146
Basic UDI-DI: 912003686TCCev100002TY
Reference: 9820501
EMDN: W0202020185
EMDN description: COAGULOMETERS - CONSUMABLES
First on market country: Austria
Authorised representative: -
Last updated: 01.08.2026 00:33

Manufacturer products View details

09120036864122

Ceveron 100 series System Solution

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH
Manufacturer SRN: AT-MF-000024115
UDI-DI: 09120036864122
Basic UDI-DI: 912003686TC990000003UE
Reference: 9820201
EMDN: W0202020185
EMDN description: COAGULOMETERS - CONSUMABLES
First on market country: Austria
Authorised representative: -
Last updated: 01.08.2026 00:33

Manufacturer products View details

09120036864061

Ceveron Cleaning Solution

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH
Manufacturer SRN: AT-MF-000024115
UDI-DI: 09120036864061
Basic UDI-DI: 912003686TC990000002UC
Reference: 9820310
EMDN: W0202020185
EMDN description: COAGULOMETERS - CONSUMABLES
First on market country: Austria
Authorised representative: -
Last updated: 01.08.2026 00:33

Manufacturer products View details