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176 device results listed.

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URINE LOW OSMOLALITY CONTROL

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

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273220377
Basic UDI-DI: 50552732BLOOSMC160RD
Reference: UC10650
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:14

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Capillary Blood Sample Collection Kit D

IVD Class AIVDR 2017/746On the marketNo EU repKitSingle use

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273220292
Basic UDI-DI: 50552732ACBSCKD0615C
Reference: SCK10719
EMDN: W0501010201
EMDN description: CAPILLARY BLOOD COLLECTION SYSTEMS
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:14

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Capillary Blood Sample Collection Kit C

VENOUS BLOOD SAMPLE COLLECTION KIT

IVD Class AIVDR 2017/746On the marketNo EU repKitSingle use

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273220179
Basic UDI-DI: 50552732ACBSCKC06053
Reference: SCK10674
EMDN: W0501010201
EMDN description: CAPILLARY BLOOD COLLECTION SYSTEMS
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:14

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Capillary Blood Sample Collection Kit A

IVD Class AIVDR 2017/746On the marketNo EU repKitSingle use

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273220155
Basic UDI-DI: 50552732ACBSCKA05852
Reference: SCK10672
EMDN: W0501010201
EMDN description: CAPILLARY BLOOD COLLECTION SYSTEMS
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:14

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Capillary Blood Sample Collection Kit B

IVD Class AIVDR 2017/746On the marketNo EU repKitSingle use

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273220148
Basic UDI-DI: 50552732ACBSCKB0595B
Reference: SCK10673
EMDN: W0501010201
EMDN description: CAPILLARY BLOOD COLLECTION SYSTEMS
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:14

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VENOUS BLOOD SAMPLE COLLECTION KIT 1

VENOUS BLOOD SAMPLE COLLECTION KIT

IVD Class AIVDR 2017/746On the marketNo EU repKitSingle use

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273220032
Basic UDI-DI: 50552732AVBSCKT055NN
Reference: SCK10694
EMDN: W0501010199
EMDN description: VENOUS OR ARTERIOUS BLOOD COLLECTION DEVICES - OTHER
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:13

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UNIVERSAL FAECAL SAMPLE COLLECTION KIT

IVD Class AIVDR 2017/746On the marketNo EU repKitProfessional testingSingle use

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273220025
Basic UDI-DI: 50552732AUFSCKT054Q9
Reference: SCK10693
EMDN: W05019001
EMDN description: FAECES COLLECTION DEVICES
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:13

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Evidence MultiSTAT Drugs of Abuse (DOA) ToxPlex Urine Array

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

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273220001
Basic UDI-DI: 50552732CTXPLXU068B8
Reference: EV4505
EMDN: W0102090199
EMDN description: DRUGS OF ABUSE - OTHER
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:13

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Microbiome Home Sample Collection Kit

IVD Class AIVDR 2017/746On the marketNo EU repKitSingle use

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273219876
Basic UDI-DI: 50552732AHMSCKT057K9
Reference: SCK10665
EMDN: W05019001
EMDN description: FAECES COLLECTION DEVICES
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:13

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PARATHYROID HORMONE CONTROL - LEVEL 1 (PTH CONTROL 1)

PTH CONTROL

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

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273219814
Basic UDI-DI: 50552732BPTHSMT176XP
Reference: PTH10608
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:13

Manufacturer products View details

Premium Capillary Blood Sample Collection Kit

IVD Class AIVDR 2017/746On the marketNo EU repKitProfessional testingSingle use

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273219807
Basic UDI-DI: 50552732ACAPCOL05167
Reference: SCK10677
EMDN: W0501010201
EMDN description: CAPILLARY BLOOD COLLECTION SYSTEMS
First on market country: Ireland
Authorised representative: -
Last updated: 31.07.2026 08:13

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Evidence MultiSTAT SHBG

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

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273219609
Basic UDI-DI: 50552732BSHBGAK163CA
Reference: EV4514
EMDN: W0102050109
EMDN description: SEX HORMONE BINDING GLOBULIN
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:13

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Evidence MultiSTAT SHBG Control

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

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273219593
Basic UDI-DI: 50552732BSHBGCK164D2
Reference: EV4533
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:13

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Evidence MultiSTAT Testosterone Control

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

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273219586
Basic UDI-DI: 50552732BTESCON162Q2
Reference: EV4532
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:13

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Evidence MultiSTAT Testosterone

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

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273219555
Basic UDI-DI: 50552732BTESASS161RM
Reference: EV4513
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:13

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Home Saliva Collection Kit

IVD Class AIVDR 2017/746On the marketNo EU repKitSingle use

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273219333
Basic UDI-DI: 50552732AHSSCKT056NR
Reference: SCK10654
EMDN: W05019002
EMDN description: SALIVA COLLECTION DEVICES
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:13

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SERUM BONE MARKER LEVEL 1 CONTROL (SERUM BONE MARKER CONTROL 1)

SERUM BONE MARKER CONTROL

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

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273219098
Basic UDI-DI: 50552732BSUBOMK154TC
Reference: SBM10574
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:13

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ACTIVE VITAMIN B12 CONTROL LEVEL 1 (Active Vitamin B12 CONTROL 1)

ACTIVE VITAMIN B12 CONTROL

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

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273219029
Basic UDI-DI: 50552732BAVB12C173QK
Reference: VB10524
EMDN: W0102152006
EMDN description: ANAEMIA RELATED/VITAMIN CONTROLS
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:13

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PRE-ECLAMPSIA CONTROL LEVEL 3 (Pre-eclampsia CONTROL 3)

PRE-ECLAMPSIA CONTROL

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

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273218992
Basic UDI-DI: 50552732CPREECL063JH
Reference: PE10529
EMDN: W01021521
EMDN description: MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:13

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ConcizuTrace™ ELISA

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

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273218985
Basic UDI-DI: 50552732CCELISA0649X
Reference: CZM10591
EMDN: W01020899
EMDN description: THERAPEUTIC DRUG MONITORING - OTHER
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:13

Manufacturer products View details