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AUTION ELEVEN (AE-4020)

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: 04987486033134
Basic UDI-DI: 4987486BC0107308GN
Reference: 107308
EMDN: W020101020102
EMDN description: SEMI-AUTOMATED URINE ANALYSERS
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 31.07.2026 07:32

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Concentrated Washing Solution 3

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: 04987486033103
Basic UDI-DI: 4987486BC0107293H2
Reference: 107293
EMDN: W020101020185
EMDN description: AUTOMATED URINE ANALYSERS - CONSUMABLES
First on market country: Belgium
Authorised representative: ARKRAY Europe, B.V.
Last updated: 31.07.2026 07:32

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The Lab 004 (DB-3910)

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: 04987486028659
Basic UDI-DI: 4987486BC0105581GU
Reference: 105581
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 31.07.2026 07:32

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HM-CODIAM

IVD Class AIVDR 2017/746On the marketInstrumentKitProfessional testing

Manufacturer: Canon Medical Diagnostics Corporation
Manufacturer SRN: JP-MF-000020364
UDI-DI: 04987295660903
Basic UDI-DI: 4987295BU00422
Reference: 66090
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Spain
Authorised representative: Obelis s.a.
Last updated: 31.07.2026 07:32

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Wash Liquid (Auto Detergent H)

HM-JACKarcⅡ

IVD Class AIVDR 2017/746On the marketInstrumentKitProfessional testing

Manufacturer: Canon Medical Diagnostics Corporation
Manufacturer SRN: JP-MF-000020364
UDI-DI: 04987295524045
Basic UDI-DI: 4987295BU002ZT
Reference: 52404
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Spain
Authorised representative: Obelis s.a.
Last updated: 31.07.2026 07:32

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AA01

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Otsuka Electronics Co., Ltd.
Manufacturer SRN: JP-MF-000001943
UDI-DI: 04987274142079
Basic UDI-DI: 4987274W0201010101A01EW
Reference: 04987274142079
EMDN: W0201010105
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400)
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 07:32

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NS-Prime

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Otsuka Electronics Co., Ltd.
Manufacturer SRN: JP-MF-000001943
UDI-DI: 04987274142093
Basic UDI-DI: 4987274W0201010101PRMN2
Reference: 04987274142093
EMDN: W0201010105
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400)
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 07:32

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OC-SENSOR PLEDIA

OC Equipment Family

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: EIKEN CHEMICAL CO., LTD.
Manufacturer SRN: JP-MF-000018097
UDI-DI: 04987026213194
Basic UDI-DI: 4987026TD-OCEQZ5
Reference: MV5H00
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Italy
Authorised representative: Advena Limited
Last updated: 31.07.2026 07:31

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EX-D

EX-D/Ds

IVD Class AIVDR 2017/746On the marketInstrumentKit

Manufacturer: JOKOH CO.,LTD.
Manufacturer SRN: JP-MF-000025161
UDI-DI: 04980679110124
Basic UDI-DI: 498067911012JN
Reference: J11012
EMDN: W0201040201
EMDN description: ION SELECTIVE ELECTROLYTE ANALYSERS
First on market country: Greece
Authorised representative: MDSS GmbH
Last updated: 31.07.2026 07:31

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IVD Class ANot specifiedOn the marketDirect marking

Manufacturer: MR INTERNATIONAL HEALTHCARE TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000047634
UDI-DI: 04897146460104
Basic UDI-DI: 489714646MR003JE
Reference: HTSH-2000
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Hungary
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 31.07.2026 07:18

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IVD Class ANot specifiedOn the marketDirect marking

Manufacturer: MR INTERNATIONAL HEALTHCARE TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000047634
UDI-DI: 04897146460012
Basic UDI-DI: 489714646MR001JA
Reference: YD-200
EMDN: W020101020102
EMDN description: SEMI-AUTOMATED URINE ANALYSERS
First on market country: Hungary
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 31.07.2026 07:18

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Elextroline 100 Ca

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: MDX Netherlands Diagnostics inc
Manufacturer SRN: PH-MF-000050095
UDI-DI: 04806541360209
Basic UDI-DI: 480654136ELECANAEF
Reference: Elextroline 100 Ca
EMDN: W02010499
EMDN description: BLOOD GAS ANALYSIS / ELECTROLYTE INSTRUMENTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 07:08

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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

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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

Manufacturer products Authorised representative products Authorised representative actors View details