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Washing solution

CY001-WS

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Cypress Diagnostics
Manufacturer SRN: BE-MF-000000033
UDI-DI: 05404035100325
Basic UDI-DI: 54040351CY0015L
Reference: CY001-WS
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 10:46

Manufacturer products View details

CYANElite 290

CY015

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Cypress Diagnostics
Manufacturer SRN: BE-MF-000000033
UDI-DI: 05404035100295
Basic UDI-DI: 54040351CY0155X
Reference: CY015
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 10:45

Manufacturer products View details

TruAna

IVD Class ANot specifiedOn the market

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763907
Basic UDI-DI: 5065023763TA10001RC
Reference: TA10001
EMDN: W0201010105
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400)
First on market country: Germany
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 09:22

Manufacturer products Authorised representative products Authorised representative actors View details

TruReno

IVD Class ANot specifiedOn the market

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763884
Basic UDI-DI: 5065023763TR10001Y9
Reference: TR10001
EMDN: W0201010105
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400)
First on market country: Poland
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 09:22

Manufacturer products Authorised representative products Authorised representative actors View details

05070002421313

Dxcover Sample Slides

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: Dxcover Limited
Manufacturer SRN: UK-MF-000046906
UDI-DI: 05070002421313
Basic UDI-DI: 50700024213SampleSlidesNW
Reference: DXC-SS-001
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Ireland
Authorised representative: CS Life Sciences Europe Ltd
Last updated: 31.07.2026 09:19

Manufacturer products Authorised representative products Authorised representative actors View details

05070002421306

Dxcover Brain Cancer Diagnostic Software

IVD Class CIVDR 2017/746On the marketProfessional testing

Manufacturer: Dxcover Limited
Manufacturer SRN: UK-MF-000046906
UDI-DI: 05070002421306
Basic UDI-DI: 50700024213LiqBiopPltfm4Y
Reference: DXCBRAIN
EMDN: W0201010192
EMDN description: CHEMISTRY ANALYSERS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Ireland
Authorised representative: CS Life Sciences Europe Ltd
Last updated: 31.07.2026 09:19

Manufacturer products Authorised representative products Authorised representative actors View details

ISE DETERGENT (ISE DET)

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

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273215045
Basic UDI-DI: 50552732AISEDET032DX
Reference: RX8128
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

ACID WASH SOLUTION (WASH SOLN. 3)

IVD Class AIVDR 2017/746On the marketNo EU repKitReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273215021
Basic UDI-DI: 50552732AAWSOLN028PU
Reference: RX8129
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

ISE BUFFER (ISE BUF)

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

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273215014
Basic UDI-DI: 50552732AISEBUF031FH
Reference: RX8126
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

ALKALINE WASH SOLUTION (WASH soln. 9)

IVD Class AIVDR 2017/746On the marketNo EU repKitReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273215007
Basic UDI-DI: 50552732AALSOLN029HD
Reference: RX8130
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 modena

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

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273214963
Basic UDI-DI: 50552732AMODENA033DB
Reference: RX9000
EMDN: W0201010106
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (with ISE mode test/h > 400 and <= 800)
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:12

Manufacturer products View details

I.S.E. DILUENT (ISE DIL)

IVD Class AIVDR 2017/746On the marketNo EU repKitReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273214376
Basic UDI-DI: 50552732AISEDIL011DB
Reference: RX4049
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

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: 05055273214529
Basic UDI-DI: 50552732AAWSOLN016PM
Reference: WS8397
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

ETCHING (ETCH)

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

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273214369
Basic UDI-DI: 50552732ARXETCH012SD
Reference: RX4048
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. CLEANER (ISE CLN)

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

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273214352
Basic UDI-DI: 50552732AISECLN044EU
Reference: RX4047
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

ALKALINE DETERGENT (Alkaline Detergent)

IVD Class AIVDR 2017/746On the marketNo EU repKitReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273210385
Basic UDI-DI: 50552732AALKDET0357E
Reference: RX8108
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

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