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176 device results listed.

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Microbiome Home Sample Collection Kit

IVD Class AIVDR 2017/746On the marketNo EU repKit

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273219876
Basic UDI-DI: 50552732AHMSCKT057K9
Reference: SCK10665
EMDN: -
EMDN description: FAECES COLLECTION DEVICES
First on market country: Northern Ireland
Authorised representative: -
Last updated: 02.07.2026 01:42

Manufacturer products View details

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: -
EMDN description: HORMONE CONTROLS
First on market country: Northern Ireland
Authorised representative: -
Last updated: 02.07.2026 01:42

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VENOUS BLOOD SAMPLE COLLECTION KIT 1

VENOUS BLOOD SAMPLE COLLECTION KIT

IVD Class AIVDR 2017/746On the marketNo EU repKit

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273220032
Basic UDI-DI: 50552732AVBSCKT055NN
Reference: SCK10694
EMDN: -
EMDN description: VENOUS OR ARTERIOUS BLOOD COLLECTION DEVICES - OTHER
First on market country: Northern Ireland
Authorised representative: -
Last updated: 02.07.2026 01:42

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UNIVERSAL FAECAL SAMPLE COLLECTION KIT

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

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273220025
Basic UDI-DI: 50552732AUFSCKT054Q9
Reference: SCK10693
EMDN: -
EMDN description: FAECES COLLECTION DEVICES
First on market country: Northern Ireland
Authorised representative: -
Last updated: 02.07.2026 01:42

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Premium Capillary Blood Sample Collection Kit

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

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273219807
Basic UDI-DI: 50552732ACAPCOL05167
Reference: SCK10677
EMDN: -
EMDN description: CAPILLARY BLOOD COLLECTION SYSTEMS
First on market country: Ireland
Authorised representative: -
Last updated: 02.07.2026 01:42

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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: -
EMDN description: SEX HORMONE BINDING GLOBULIN
First on market country: Northern Ireland
Authorised representative: -
Last updated: 02.07.2026 01:42

Manufacturer products View details

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: -
EMDN description: HORMONE CONTROLS
First on market country: Northern Ireland
Authorised representative: -
Last updated: 02.07.2026 01:42

Manufacturer products View details

Home Saliva Collection Kit

IVD Class AIVDR 2017/746On the marketNo EU repKit

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273219333
Basic UDI-DI: 50552732AHSSCKT056NR
Reference: SCK10654
EMDN: -
EMDN description: SALIVA COLLECTION DEVICES
First on market country: Northern Ireland
Authorised representative: -
Last updated: 02.07.2026 01:42

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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: -
EMDN description: ANAEMIA RELATED/VITAMIN CONTROLS
First on market country: Northern Ireland
Authorised representative: -
Last updated: 02.07.2026 01:42

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ConcizuTrace™ Sample Collection Kit

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

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273218879
Basic UDI-DI: 50552732ACTSCKT047KQ
Reference: CZM10594
EMDN: -
EMDN description: VENOUS OR ARTERIOUS BLOOD COLLECTION DEVICES - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 02.07.2026 01:42

Manufacturer products View details

ALDOLASE AND GLUTATHIONE REDUCTASE LEVEL 2 CONTROL (ALS & GLUT RED CONTROL 2)

ALDOLASE AND GLUTATHIONE REDUCTASE CONTROL

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

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273218848
Basic UDI-DI: 50552732BAGRCON157B9
Reference: AGR10572
EMDN: -
EMDN description: ASSAYED MULTICOMPONENT CONTROLS (CC)
First on market country: Northern Ireland
Authorised representative: -
Last updated: 02.07.2026 01:42

Manufacturer products View details

ALDOLASE AND GLUTATHIONE REDUCTASE CALIBRATOR (ALS & GLUT RED CAL)

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

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273218831
Basic UDI-DI: 50552732BAGRCAL1565X
Reference: AGR10571
EMDN: -
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Northern Ireland
Authorised representative: -
Last updated: 02.07.2026 01:42

Manufacturer products View details

SEROLOGY HBeAg POSITIVE CONTROL (HBeAg CONTROL +)

SEROLOGY HBeAg POSITIVE CONTROL

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

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273217933
Basic UDI-DI: 50552732BHBPOCT140DS
Reference: SR10459
EMDN: -
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Northern Ireland
Authorised representative: -
Last updated: 02.07.2026 01:42

Manufacturer products View details

Custom Bilirubin Control - Level 3 (CUSTOM BILIRUBIN CONTROL 3)

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

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273217926
Basic UDI-DI: 50552732BLBCNL30345F
Reference: BR10391
EMDN: -
EMDN description: BILIRUBIN CONTROLS
First on market country: Northern Ireland
Authorised representative: -
Last updated: 02.07.2026 01:42

Manufacturer products View details

CONFIDANTE

IVD Class AIVDR 2017/746On the marketNo EU repKit

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273217919
Basic UDI-DI: 50552732ACONSTI017LZ
Reference: EV3879
EMDN: -
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: Northern Ireland
Authorised representative: -
Last updated: 02.07.2026 01:42

Manufacturer products View details

CUSTOM LIQUID IMMUNOASSAY CONTROL - LEVEL 1

CUSTOM LIQUID IMMUNOASSAY CONTROL

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

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273217513
Basic UDI-DI: 50552732BLIC123180MW
Reference: LIA3148
EMDN: -
EMDN description: MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country: Northern Ireland
Authorised representative: -
Last updated: 02.07.2026 01:42

Manufacturer products View details

CUSTOM LIQUID THERAPEUTIC DRUG CONTROL - LEVEL 1

CUSTOM LIQUID THERAPEUTIC DRUG CONTROL

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

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273217315
Basic UDI-DI: 50552732BLTDCON177KM
Reference: HD3145
EMDN: -
EMDN description: TDM/DRUG CONTROLS
First on market country: Northern Ireland
Authorised representative: -
Last updated: 02.07.2026 01:42

Manufacturer products View details

Home Blood Sample Collection Kit

IVD Class AIVDR 2017/746On the marketNo EU repKit

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273217254
Basic UDI-DI: 50552732AHBLSCK042AD
Reference: EV4460
EMDN: -
EMDN description: CAPILLARY BLOOD COLLECTION SYSTEMS
First on market country: Northern Ireland
Authorised representative: -
Last updated: 02.07.2026 01:42

Manufacturer products View details

CARDIAC CONTROL - ULTRA LOW (CRD CONTROL Ultra Low)

CARDIAC CONTROL

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

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273217117
Basic UDI-DI: 50552732BCRDCON001AS
Reference: CQ10453
EMDN: -
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Northern Ireland
Authorised representative: -
Last updated: 02.07.2026 01:42

Manufacturer products View details

SEROLOGY HIV-1 P24Ag POSITIVE CONTROL (HIV-1 P24Ag CONTROL +)

SEROLOGY HIV-1 P24Ag POSITIVE CONTROL

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

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273217100
Basic UDI-DI: 50552732BAGPOCO125AR
Reference: SR10458
EMDN: -
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Northern Ireland
Authorised representative: -
Last updated: 02.07.2026 01:42

Manufacturer products View details