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SpotChem D-Concept 2c (SD-4830)

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: 04987486047186
Basic UDI-DI: 4987486BC0110044F5
Reference: 110044
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 07:33

Manufacturer products Authorised representative products Authorised representative actors View details

AutionIDaten (AE-4070)

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: 04987486039594
Basic UDI-DI: 4987486BC0108412GR
Reference: 108412
EMDN: W020101020102
EMDN description: SEMI-AUTOMATED URINE ANALYSERS
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 31.07.2026 07:33

Manufacturer products Authorised representative products Authorised representative actors View details

PocketChem BA (PA-4140)

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: 04987486036227
Basic UDI-DI: 4987486BC0107687HT
Reference: 107687
EMDN: W0201010203
EMDN description: BLOOD-AMMONIA CHECKERS
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 31.07.2026 07:33

Manufacturer products Authorised representative products Authorised representative actors View details

SPOTCHEM EZ (SP-4430)

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: 04987486034551
Basic UDI-DI: 4987486BC0107501GJ
Reference: 107501
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 07:33

Manufacturer products Authorised representative products Authorised representative actors View details

PocketChem UA (PU-4010)

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: 04987486033370
Basic UDI-DI: 4987486BC0107332GK
Reference: 107332
EMDN: W020101020102
EMDN description: SEMI-AUTOMATED URINE ANALYSERS
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 31.07.2026 07:33

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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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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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

DOASENSE Reader

0002

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

Manufacturer: DOASENSE GmbH
Manufacturer SRN: DE-MF-000015367
UDI-DI: 04260552660022
Basic UDI-DI: 426055266ReaderXY
Reference: 0002
EMDN: W020101020101
EMDN description: URINE STRIP READERS
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 02:11

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