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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: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:13

Manufacturer products View details

XANTHOCHROMIA POSITIVE CONTROL (XANTHOCHROMIA CONTROL +)

XANTHOCHROMIA CONTROL

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

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273218725
Basic UDI-DI: 50552732BXTHPON1553F
Reference: XN10505
EMDN: W0101050102
EMDN description: UNASSAYED MULTICOMPONENT CONTROLS (CC)
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:13

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SERUM INDICES (SERUM INDICES)

SERUM INDICES

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

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273217025
Basic UDI-DI: 50552732BSEMDCE128EF
Reference: SI10448
EMDN: W0101050102
EMDN description: UNASSAYED MULTICOMPONENT CONTROLS (CC)
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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Liquid Immunoassay Control - Level 1 (IA CONTROL 1)

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: 05055273210101
Basic UDI-DI: 50552732BLIACON169BJ
Reference: LIA5142
EMDN: W0101050102
EMDN description: UNASSAYED MULTICOMPONENT CONTROLS (CC)
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:12

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sLDL CONTROL LEVEL 1 (sLDL CONTROL 1)

sLDL CONTROL

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

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273209075
Basic UDI-DI: 50552732BSLDLCL099K6
Reference: LE5013
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:11

Manufacturer products View details

sLDL CALIBRATOR (sLDL CAL)

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

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273208436
Basic UDI-DI: 50552732BSLDLCR100K8
Reference: CH5050
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:11

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LIQUID CHEMISTRY PREMIUM PLUS - LEVEL 1 (LIQ CHEM PREMIUM PLUS 1)

LIQUID CHEMISTRY PREMIUM PLUS

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

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273207132
Basic UDI-DI: 50552732BCUQCON121KT
Reference: LUL5069
EMDN: W0101050102
EMDN description: UNASSAYED MULTICOMPONENT CONTROLS (CC)
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:11

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HUMAN PRECISION CONTROL - LEVEL 3 (HUM PREC CONTROL 3)

HUMAN PRECISION CONTROL

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

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273206791
Basic UDI-DI: 50552732BHUPNCN127PL
Reference: UE1558
EMDN: W0101050102
EMDN description: UNASSAYED MULTICOMPONENT CONTROLS (CC)
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:11

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MICROALBUMIN CALIBRATOR SERIES (mALB CAL)

MICROALBUMIN CALIBRATOR SERIES

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

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273204520
Basic UDI-DI: 50552732BMALBCL08688
Reference: MA1567
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:11

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LIPID CONTROL - LEVEL 1 (LPD CONTROL 1)

LIPID CONTROL

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

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273204155
Basic UDI-DI: 50552732BLPDCON080GR
Reference: LE2661
EMDN: W0101050202
EMDN description: LIPID CONTROLS
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:11

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AMMONIA ETHANOL CONTROL - LEVEL 1 (NH3/EtOH CONTROL 1)

AMMONIA ETHANOL CONTROL

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

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273202090
Basic UDI-DI: 50552732BAMMCON049C2
Reference: EA1366
EMDN: W0101050101
EMDN description: ASSAYED MULTICOMPONENT CONTROLS (CC)
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:11

Manufacturer products View details

DIRECT LDL/HDL CHOLESTEROL CALIBRATOR

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

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273201239
Basic UDI-DI: 50552732BDIHDCA02628
Reference: CH2673
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:11

Manufacturer products View details

CSF CONTROL - LEVEL 2 (CSF CONTROL 2)

CSF CONTROL

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

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273201116
Basic UDI-DI: 50552732BCSFCON038D6
Reference: CF1500
EMDN: W0101050208
EMDN description: CSF CONTROLS
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:11

Manufacturer products View details

ALDOLASE LEVEL 2 CONTROL (ALS CONTROL 2)

ALDOLASE CONTROL

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

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273200096
Basic UDI-DI: 50552732BALSCON005DZ
Reference: AD5001
EMDN: W0101050201
EMDN description: ENZYME CONTROLS
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:11

Manufacturer products View details

ALDOLASE CALIBRATION SERUM (ALS CAL)

ALDOLASE CALIBRATION SERUM

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

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273200089
Basic UDI-DI: 50552732BALSCAL0048P
Reference: AD5000
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:11

Manufacturer products View details

small dense LDL-Control Set

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testing

Manufacturer: Denka Co., Ltd.
Manufacturer SRN: JP-MF-000015952
UDI-DI: 04987503563088
Basic UDI-DI: 4987503sdLDLconPA
Reference: 08834105190
EMDN: W0101050202
EMDN description: LIPID CONTROLS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 07:34

Manufacturer products Authorised representative products Authorised representative actors View details

small dense LDL-Calibrator

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testing

Manufacturer: Denka Co., Ltd.
Manufacturer SRN: JP-MF-000015952
UDI-DI: 04987503563071
Basic UDI-DI: 4987503sdLDLcalMU
Reference: 08834091190
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 07:34

Manufacturer products Authorised representative products Authorised representative actors View details

trister® Control Solution

IVD Class CIVDR 2017/746On the marketNear-patient testingProfessional testingReagentSelf testing

Manufacturer: All Medicus Co., Ltd.
Manufacturer SRN: KR-MF-000020833
UDI-DI: 08806128310609
Basic UDI-DI: 88061283AGM2100CD9
Reference: AGM-2100-C2-S1
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: -
Safety summary (SSCP/SSP): AM-TD-G01-06 · Rev. 04
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 31.07.2026 01:26

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

G1 Advance Control Solution

IVD Class CIVDR 2017/746On the marketNear-patient testingProfessional testingReagentSelf testing

Manufacturer: All Medicus Co., Ltd.
Manufacturer SRN: KR-MF-000020833
UDI-DI: 08806128340408
Basic UDI-DI: 88061283AGM4000CDQ
Reference: AGM-4000-C2-S1
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: -
Safety summary (SSCP/SSP): AM-TD-G10-06 · Rev. 01
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 31.07.2026 01:26

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details