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ANTI-BACTERIAL DETERGENT (Detergent)

IVD Class AIVDR 2017/746On the marketNo EU repKitProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273210378
Basic UDI-DI: 50552732AANBDET0363V
Reference: RX8106
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:12

Manufacturer products View details

I.S.E. CLEANING SOLUTION (I.S.E. SOLN WASH)

IVD Class AIVDR 2017/746On the marketNo EU repKitProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273210361
Basic UDI-DI: 50552732AISESOL006MP
Reference: RX4003
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:12

Manufacturer products View details

RX daytona plus (with ISE)

RX daytona plus

IVD Class AIVDR 2017/746On the marketNo EU repDirect markingInstrumentProfessional testing

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273207774
Basic UDI-DI: 50552732ADAYPLU015HS
Reference: RX4040
EMDN: W0201010105
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400)
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:11

Manufacturer products View details

RX monaco

IVD Class AIVDR 2017/746On the marketNo EU repDirect markingInstrumentProfessional testing

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273207750
Basic UDI-DI: 50552732AMONACO037GJ
Reference: RX5000
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:11

Manufacturer products View details

ACID WASH SOLUTION (AWS)

IVD Class AIVDR 2017/746On the marketNo EU repKitProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273206982
Basic UDI-DI: 50552732AAWSOLN001P8
Reference: WS3853
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:11

Manufacturer products View details

RX imola

IVD Class AIVDR 2017/746On the marketNo EU repDirect markingInstrumentProfessional testing

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273206104
Basic UDI-DI: 50552732ARXIMOL025WX
Reference: RX4900
EMDN: W0201010105
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400)
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:11

Manufacturer products View details

C1 Solution (C1 SOLN)

C1 SOLUTION (C1 SOLN)

IVD Class AIVDR 2017/746On the marketNo EU repKitProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273206074
Basic UDI-DI: 50552732AC1SOLN00937
Reference: RX3973
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:11

Manufacturer products View details

RX WASH CONCENTRATE (WASH conc. 3)

RX WASH CONCENTRATE (WASH conc.)

IVD Class AIVDR 2017/746On the marketNo EU repKitProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273205947
Basic UDI-DI: 50552732AWASCON008NK
Reference: RX3946
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:11

Manufacturer products View details

JCA-BM6070/C

BM Family

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: JEOL Ltd. MF
Manufacturer SRN: JP-MF-000026608
UDI-DI: 04987762049088
Basic UDI-DI: 4987762B04900KK
Reference: CA-20241BM607C
EMDN: W0201010108
EMDN description: CHEMISTRY ANALYSERS - HIGH ROUTINE (with ISE mode test/h > 1.200)
First on market country: Netherlands
Authorised representative: JEOL(Europe)BV AR
Last updated: 31.07.2026 07:43

Manufacturer products Authorised representative products Authorised representative actors View details

UC-1100

UC-1100 Semi-Automated Urine Chemistry Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: 04987562527724
Basic UDI-DI: 4987562UC-1100RE
Reference: CM509660
EMDN: W020101020101
EMDN description: URINE STRIP READERS
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 31.07.2026 07:42

Manufacturer products Authorised representative products Authorised representative actors View details

04987562505210

Urine Sample Decapper Unit

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: 04987562505210
Basic UDI-DI: 4987562TH-113S
Reference: CZ583355
EMDN: W020101020180
EMDN description: AUTOMATED URINE ANALYSERS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 31.07.2026 07:41

Manufacturer products Authorised representative products Authorised representative actors View details

ST-10

Urine Sample Transportation Unit

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: 04987562461554
Basic UDI-DI: 4987562UrineUnitBL
Reference: BQ027353
EMDN: W020101020180
EMDN description: AUTOMATED URINE ANALYSERS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 31.07.2026 07:41

Manufacturer products Authorised representative products Authorised representative actors View details

U-WAM

Urinalysis Work Area Information Management System

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: 04987562444694
Basic UDI-DI: 4987562U-WAM7X
Reference: AM594637
EMDN: W020101020182
EMDN description: AUTOMATED URINE ANALYSERS - SOFTWARE ACCESSORIES
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 31.07.2026 07:41

Manufacturer products Authorised representative products Authorised representative actors View details

SA-51

UF Sampler Unit

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: 04987562440146
Basic UDI-DI: 4987562UFSamplerUnit95
Reference: AA297665
EMDN: W020101020180
EMDN description: AUTOMATED URINE ANALYSERS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 31.07.2026 07:41

Manufacturer products Authorised representative products Authorised representative actors View details

04987562511679

SA-52 Sampler Unit

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: 04987562511679
Basic UDI-DI: 4987562SA-522C
Reference: AR763673
EMDN: W020101020180
EMDN description: AUTOMATED URINE ANALYSERS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 31.07.2026 07:36

Manufacturer products Authorised representative products Authorised representative actors View details

SpotChem D-Concept 2e (SD-4840)

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: 04987486047216
Basic UDI-DI: 4987486BC0110046F9
Reference: 110046
EMDN: W0201010105
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400)
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 31.07.2026 07:34

Manufacturer products Authorised representative products Authorised representative actors View details

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