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MDX HPLCLine 100

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: MDX Netherlands Diagnostics inc
Manufacturer SRN: PH-MF-000050095
UDI-DI: 04806541360100
Basic UDI-DI: 480654136HPLCANAL3
Reference: MDX HPLCLine 100
EMDN: W0201050201
EMDN description: HIGH PERFORMANCE LIQUID CHROMATOGRAPHY SYSTEMS
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 07:08

Manufacturer products Authorised representative products Authorised representative actors View details

Agnitio BioIC Analyzer

BA-G2000 series/BA-G2012 series/BA400 series/ BA1200 series/BA2400 series

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: AGNITIO SCIENCE &TECHNOLOGY,INC.
Manufacturer SRN: TW-MF-000040942
UDI-DI: 04719892999014
Basic UDI-DI: 471989299Analyzer8A
Reference: BA-G2000 series
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 31.07.2026 06:51

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PlexBio 100 Fluorescent Analyzer

PB100

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

Manufacturer: PlexBio Co., Ltd.
Manufacturer SRN: TW-MF-000031803
UDI-DI: 04719882810015
Basic UDI-DI: 471988281MultiplexFAM3
Reference: 80000-2
EMDN: W02010199
EMDN description: CHEMISTRY INSTRUMENTS - OTHER
First on market country: Poland
Authorised representative: MDSS GmbH
Last updated: 31.07.2026 06:47

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KETOSURE POC

KETOSURE POC base unit

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

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: 04713648764581
Basic UDI-DI: 47136487607B00KBUa79
Reference: M033
EMDN: W0201069080
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 31.07.2026 06:29

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KETOSURE POC

KETOSURE POC Blood Ketone Monitoring System

IVD Class AIVDR 2017/746On the market

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: 04713648764574
Basic UDI-DI: 47136487607B00KMbYP
Reference: M032
EMDN: W020106019099
EMDN description: VARIOUS DIABETES MONITORING INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 31.07.2026 06:29

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Eclipse PLUS

Eclipse PLUS Multi-Purpose Analyzer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentNear-patient testing

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: 04713648762198
Basic UDI-DI: 47136487606B00MCSa73
Reference: M034
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 31.07.2026 06:29

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BIOLIS 30i

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Biolis Medical Corp.
Manufacturer SRN: JP-MF-000025468
UDI-DI: 04580262016002
Basic UDI-DI: 458026201BIOLIS30i2W
Reference: 60-01-0001
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Northern Ireland
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 31.07.2026 06:14

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Alkaline Washing Solution

Washing Solution

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Biolis Medical Corp.
Manufacturer SRN: JP-MF-000025468
UDI-DI: 04580262010208
Basic UDI-DI: 458026201WSTE
Reference: SP2208
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Northern Ireland
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 31.07.2026 06:14

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FUJI PLAIN TUBE

IVD Class AIVDR 2017/746On the marketNear-patient testingProfessional testingSingle use

Manufacturer: FUJIFILM Corporation
Manufacturer SRN: JP-MF-000010401
UDI-DI: 04902520282774
Basic UDI-DI: 454741030100000000000436U
Reference: 04902520282774
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Netherlands
Authorised representative: FUJIFILM Healthcare Europe GmbH
Last updated: 31.07.2026 06:04

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FUJI DRI-CHEM CLEAN TIPS

IVD Class AIVDR 2017/746On the marketNear-patient testingProfessional testingSingle use

Manufacturer: FUJIFILM Corporation
Manufacturer SRN: JP-MF-000010401
UDI-DI: 04902520282514
Basic UDI-DI: 4547410301000000000003873
Reference: 04902520282514
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Netherlands
Authorised representative: FUJIFILM Healthcare Europe GmbH
Last updated: 31.07.2026 06:04

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501RP+

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 04562185402094
Basic UDI-DI: 45601892100040057P
Reference: 0023295
EMDN: W0201050292
EMDN description: HIGH PERFORMANCE LIQUID CHROMATOGRAPHY SYSTEMS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 31.07.2026 06:01

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Automated Chemiluminescent Enzyme Immunoassay Analyzer AIA-CL2400

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 04562185396904
Basic UDI-DI: 45601892100040047M
Reference: 0023650
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 31.07.2026 06:01

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AUTOMATED ENZYME IMMUNOASSAY SYSTEM AIA-360

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 04560189282896
Basic UDI-DI: 45601892100040017F
Reference: 0019945
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 31.07.2026 05:58

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90 Sample Loader G8-90SL

Tosoh Automated Glycohemoglobin Analyzer HLC-723G8

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 04560189238787
Basic UDI-DI: 45601892100040027H
Reference: 0021561
EMDN: W020106019080
EMDN description: VARIOUS DIABETES MONITORING INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 31.07.2026 05:58

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FUJI DRI-CHEM MIXING CUPS

IVD Class AIVDR 2017/746On the marketNear-patient testingProfessional testingSingle use

Manufacturer: FUJIFILM Corporation
Manufacturer SRN: JP-MF-000010401
UDI-DI: 04547410071696
Basic UDI-DI: 4547410301000000000003975
Reference: 04547410071696
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Netherlands
Authorised representative: FUJIFILM Healthcare Europe GmbH
Last updated: 31.07.2026 05:56

Manufacturer products Authorised representative products Authorised representative actors View details

FUJI DRI-CHEM AUTO TIPS

IVD Class AIVDR 2017/746On the marketNear-patient testingProfessional testingSingle use

Manufacturer: FUJIFILM Corporation
Manufacturer SRN: JP-MF-000010401
UDI-DI: 04547410033144
Basic UDI-DI: 454741030100000000000376Z
Reference: 04547410033144
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Netherlands
Authorised representative: FUJIFILM Healthcare Europe GmbH
Last updated: 31.07.2026 05:55

Manufacturer products Authorised representative products Authorised representative actors View details

Nexera CL HPLC SYSTEM

HIGH PERFORMANCE LIQUID CHROMATOGRAPH

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shimadzu Corporation
Manufacturer SRN: JP-MF-000025145
UDI-DI: 04540217420742
Basic UDI-DI: 4540217420000000000001739
Reference: 227-46410-55
EMDN: W0201050201
EMDN description: HIGH PERFORMANCE LIQUID CHROMATOGRAPHY SYSTEMS
First on market country: Germany
Authorised representative: Shimadzu Europa GmbH
Last updated: 31.07.2026 05:52

Manufacturer products Authorised representative products Authorised representative actors View details

SPD-40 CL

UV-VIS DETECTOR

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shimadzu Corporation
Manufacturer SRN: JP-MF-000025145
UDI-DI: 04540217420629
Basic UDI-DI: 4540217420000000000001433
Reference: 228-65312-55
EMDN: W0201050201
EMDN description: HIGH PERFORMANCE LIQUID CHROMATOGRAPHY SYSTEMS
First on market country: Germany
Authorised representative: Shimadzu Europa GmbH
Last updated: 31.07.2026 05:52

Manufacturer products Authorised representative products Authorised representative actors View details

CTO-40C CL

COLUMN OVEN

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shimadzu Corporation
Manufacturer SRN: JP-MF-000025145
UDI-DI: 04540217420605
Basic UDI-DI: 454021742000000000000122X
Reference: 228-65202-55
EMDN: W0201050201
EMDN description: HIGH PERFORMANCE LIQUID CHROMATOGRAPHY SYSTEMS
First on market country: Germany
Authorised representative: Shimadzu Europa GmbH
Last updated: 31.07.2026 05:52

Manufacturer products Authorised representative products Authorised representative actors View details

LC-40D X3 CL

SOLVENT DELIVERY MODULE

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shimadzu Corporation
Manufacturer SRN: JP-MF-000025145
UDI-DI: 04540217420544
Basic UDI-DI: 4540217420000000000000838
Reference: 228-65076-55
EMDN: W0201050201
EMDN description: HIGH PERFORMANCE LIQUID CHROMATOGRAPHY SYSTEMS
First on market country: Germany
Authorised representative: Shimadzu Europa GmbH
Last updated: 31.07.2026 05:52

Manufacturer products Authorised representative products Authorised representative actors View details