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176 device results listed.

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SEROLOGY LYME DISEASE NEGATIVE CONTROL (LYME CONTROL -)

SEROLOGY LYME DISEASE CONTROL

IVD Class BIVDR 2017/746On the marketNo EU repHuman tissuesKitProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273216387
Basic UDI-DI: 50552732BSELYDC124N4
Reference: SR10345
EMDN: W0105080807
EMDN description: MULTICONSTITUENT CONTROLS - INF.IMM.
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:12

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SOLUBLE TRANSFERRIN RECEPTORS CALIBRATOR SERIES (STFR CAL)

SOLUBLE TRANSFERRIN RECEPTORS CALIBRATOR SERIES

IVD Class BIVDR 2017/746On the marketNo EU repHuman tissuesKitProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273215557
Basic UDI-DI: 50552732BSTFCAL104KM
Reference: TF10161
EMDN: W0102152206
EMDN description: ANAEMIA RELATED/VITAMIN STANDARDS AND CALIBRATORS
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:12

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PARATHYROID HORMONE CONTROL - LEVEL 1 (PTH CONTROL 1)

PARATHYROID HORMONE CONTROL

IVD Class BIVDR 2017/746On the marketNo EU repAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273215328
Basic UDI-DI: 50552732BPHCLLC090EN
Reference: PTH10110
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:12

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URINE LOW/HIGH CALIBRATORS (ISE CAL U)

URINE LOW/HIGH CALIBRATORS

IVD Class BIVDR 2017/746On the marketNo EU repHuman tissuesKitProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273215052
Basic UDI-DI: 50552732BURLOCA066SR
Reference: IS2910
EMDN: W0101070399
EMDN description: REFERENCE MATERIALS AND BUFFERS (ELECTROLYTES) - OTHER
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:12

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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

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SERUM LOW/HIGH CALIBRATORS (ISE CAL S)

SERUM LOW/HIGH CALIBRATORS

IVD Class BIVDR 2017/746On the marketNo EU repHuman tissuesKitProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273215038
Basic UDI-DI: 50552732BSLHCAL174GL
Reference: IS2909
EMDN: W0101070399
EMDN description: REFERENCE MATERIALS AND BUFFERS (ELECTROLYTES) - OTHER
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:12

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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

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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

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evidence MULTISTAT

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

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273214970
Basic UDI-DI: 50552732AEVMULT038SS
Reference: EV4115
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:12

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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

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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

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CUSTOM LIQUID URINE CONTROL - LEVEL 1

CUSTOM LIQUID URINE CONTROL

IVD Class BIVDR 2017/746On the marketNo EU repHuman tissuesKitProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273214802
Basic UDI-DI: 50552732BLUCN121507N
Reference: UC5170
EMDN: W0101050207
EMDN description: URINE CONTROLS
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:12

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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

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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

REFERENCE SOLUTION (REF SOLN)

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

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273214338
Basic UDI-DI: 50552732AREFSOL014LC
Reference: RX4045
EMDN: W0580
EMDN description: IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES
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