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Immunotyping Control

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Helena Biosciences Europe
Manufacturer SRN: GB-MF-000028365
UDI-DI: 05056013025801
Basic UDI-DI: 505601300ULTCEIDCONTKN
Reference: V150
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: France
Authorised representative: Advena Limited
Last updated: 31.07.2026 08:22

Manufacturer products Authorised representative products Authorised representative actors 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: 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 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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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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Ultra-Low PSA Control (UL PSA Control)

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

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273218787
Basic UDI-DI: 50552732CULOPSA062XC
Reference: TU10523
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:13

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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: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:13

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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: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:13

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CUSTOM LIQUID SPECIFIC PROTEIN CONTROL - LEVEL 1

CUSTOM LIQUID SPECIFIC PROTEIN CONTROL

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

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273216615
Basic UDI-DI: 50552732BLSPC1218199
Reference: PS3151
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
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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APOLIPOPROTEIN CONTROL - LEVEL 1 (APO CONTROL 1)

APOLIPOPROTEIN CONTROL

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

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273209105
Basic UDI-DI: 50552732BAPOCON016EE
Reference: LE5016
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:11

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LIPOPROTEIN (a) CONTROL (Lp (a) CONTROL 3)

LIPOPROTEIN (a) CONTROL

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

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273204445
Basic UDI-DI: 50552732BLIPCON082K4
Reference: LP3406
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:11

Manufacturer products View details

NESCAUTO Cp Auto Control

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Alfresa Pharma Corporation
Manufacturer SRN: JP-MF-000008778
UDI-DI: 04987274126833
Basic UDI-DI: 4987274W0102152003CPC00UE
Reference: 912683
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 07:32

Manufacturer products Authorised representative products Authorised representative actors View details

OC-FCa Control LV3

OC-FCa Reagent Family

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: EIKEN CHEMICAL CO., LTD.
Manufacturer SRN: JP-MF-000018097
UDI-DI: 04987026182360
Basic UDI-DI: 4987026TD-OCFCYC
Reference: V-PH15
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Netherlands
Authorised representative: Advena Limited
Last updated: 31.07.2026 07:31

Manufacturer products Authorised representative products Authorised representative actors View details

Boditech Estradiol Control

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133050583
Basic UDI-DI: 880613305058D5
Reference: CFPO-434
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: Austria
Authorised representative: Obelis s.a.
Last updated: 31.07.2026 07:00

Manufacturer products Authorised representative products Authorised representative actors View details

B·R·A·H·M·S Hormon1 KRYPTOR QC

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: B·R·A·H·M·S GmbH
Manufacturer SRN: DE-MF-000026030
UDI-DI: 04260157632394
Basic UDI-DI: 426015763875BHorm1KQCXXCM
Reference: 087592N
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:37

Manufacturer products View details

B·R·A·H·M·S MR-proADM II KRYPTOR QC

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: B·R·A·H·M·S GmbH
Manufacturer SRN: DE-MF-000026030
UDI-DI: 04260157638495
Basic UDI-DI: 426015763847BADMIIKQCXXF5
Reference: 084792N
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:35

Manufacturer products View details

B·R·A·H·M·S sFlt-1 KRYPTOR QC

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testingReagent

Manufacturer: B·R·A·H·M·S GmbH
Manufacturer SRN: DE-MF-000026030
UDI-DI: 04260157632486
Basic UDI-DI: 426015763845BsFlt1KQCXXHH
Reference: 084592N
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:34

Manufacturer products View details

B·R·A·H·M·S Inhibin A KRYPTOR QC

IVD Class CIVDR 2017/746On the marketHuman tissuesMicrobial substancesProfessional testingReagent

Manufacturer: B·R·A·H·M·S GmbH
Manufacturer SRN: DE-MF-000026030
UDI-DI: 04260157632417
Basic UDI-DI: 426015763850BInhiAKQCXX2H
Reference: 085092N
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:34

Manufacturer products View details