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Lp(a)-CAL

IVD generalIVDDOn the marketHuman tissuesProfessional testing

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673170226
Basic UDI-DI: B-08431673170226
Reference: 1107022
EMDN: W0102152203
EMDN description: SPECIFIC PROTEIN STANDARDS AND CALIBRATORS
First on market country: Spain
Authorised representative: -
Last updated: 24.07.2026 00:21

Manufacturer products View details

ASO-CAL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testing

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673170127
Basic UDI-DI: B-08431673170127
Reference: 1107012
EMDN: W0102152210
EMDN description: STANDARDS AND CALIBRATORS FOR RHEUMATOLOGY
First on market country: Spain
Authorised representative: -
Last updated: 24.07.2026 00:21

Manufacturer products View details

RF-CAL

IVD generalIVDDOn the marketAnimal tissuesProfessional testing

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673170073
Basic UDI-DI: B-08431673170073
Reference: 1107007
EMDN: W0102152210
EMDN description: STANDARDS AND CALIBRATORS FOR RHEUMATOLOGY
First on market country: Spain
Authorised representative: -
Last updated: 24.07.2026 00:21

Manufacturer products View details

CRP-CAL

IVD generalIVDDOn the marketHuman tissuesProfessional testing

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673170028
Basic UDI-DI: B-08431673170028
Reference: 1107002
EMDN: W0102152210
EMDN description: STANDARDS AND CALIBRATORS FOR RHEUMATOLOGY
First on market country: Spain
Authorised representative: -
Last updated: 24.07.2026 00:21

Manufacturer products View details

ASO/CRP/RF-CONTROL L

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testing

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673121143
Basic UDI-DI: B-08431673121143
Reference: 1102114
EMDN: W01021521
EMDN description: MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country: Spain
Authorised representative: -
Last updated: 24.07.2026 00:21

Manufacturer products View details

PROT-CONTROL

IVD generalIVDDOn the marketHuman tissuesProfessional testing

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673120047
Basic UDI-DI: B-08431673120047
Reference: 1102004
EMDN: W0102152203
EMDN description: SPECIFIC PROTEIN STANDARDS AND CALIBRATORS
First on market country: Spain
Authorised representative: -
Last updated: 24.07.2026 00:20

Manufacturer products View details

PROT-CAL

IVD generalIVDDOn the marketHuman tissuesProfessional testing

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673120030
Basic UDI-DI: B-08431673120030
Reference: 1102003
EMDN: W0102152203
EMDN description: SPECIFIC PROTEIN STANDARDS AND CALIBRATORS
First on market country: Spain
Authorised representative: -
Last updated: 24.07.2026 00:20

Manufacturer products View details

CALPRO-CAL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testing

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673015343
Basic UDI-DI: B-08431673015343
Reference: 1107092
EMDN: W0102152203
EMDN description: SPECIFIC PROTEIN STANDARDS AND CALIBRATORS
First on market country: Spain
Authorised representative: -
Last updated: 24.07.2026 00:15

Manufacturer products View details

Lp(a)-CONTROL

IVD generalIVDDOn the marketHuman tissuesProfessional testing

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673014414
Basic UDI-DI: B-08431673014414
Reference: 1107024
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Spain
Authorised representative: -
Last updated: 24.07.2026 00:15

Manufacturer products View details

Dimension Mass Creatine Kinase MB Isoenzyme Calibrator

IVDR_67_GLA_DUB-C_C_REAG_MMB CAL

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768013706
Basic UDI-DI: 0405686901281VE
Reference: 10445023
EMDN: W0102152204
EMDN description: CARDIAC MARKER STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 22:43

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Drugs of Abuse Negative Control

IVDR_67_GLA_DUB-C_B_REAG_DOA Negative Control

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768005145
Basic UDI-DI: 0405686901095VF
Reference: 10445032
EMDN: W0102152009
EMDN description: CONTROLS FOR NARCOTICS / TOXICOLOGY
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 22:43

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Drugs of Abuse Positive Control

IVDR_67_GLA_DUB-C_B_REAG_DOA Positive Control

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768005138
Basic UDI-DI: 0405686901096VH
Reference: 10445033
EMDN: W0102152009
EMDN description: CONTROLS FOR NARCOTICS / TOXICOLOGY
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 22:43

Manufacturer products Authorised representative products Authorised representative actors View details

Emit Ethyl Alcohol Negative Calibrator

IVDR_67_GLA_DUB-C_B_REAG_Ethyl Alcohol Cals and Controls

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768001970
Basic UDI-DI: 0405686901108UX
Reference: 10445445
EMDN: W0102152209
EMDN description: DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 22:42

Manufacturer products Authorised representative products Authorised representative actors View details

Emit Calibrator B Level 1 (cutoff)

IVDR_67_GLA_DUB-C_B_REAG_Cal B Lev 1 (cutoff) Lev 2 (high)

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768001796
Basic UDI-DI: 0405686901071UZ
Reference: 10445412
EMDN: W0102152209
EMDN description: DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 22:42

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE Insulin Control Module

IVDR_67_LLB_DUB-C_B_REAG_Insulin Control Module

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414998954
Basic UDI-DI: 0405686901431V9
Reference: 10286614
EMDN: W0102152008
EMDN description: CONTROLS FOR INDIVIDUAL AND SPECIFIC HORMONES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 22:42

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE Osteocalcin Control Module

IVDR_67_LLB_DUB-C_B_REAG_Osteocalcin Control Module

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414953267
Basic UDI-DI: 0405686900556VP
Reference: 10385415
EMDN: W0102152008
EMDN description: CONTROLS FOR INDIVIDUAL AND SPECIFIC HORMONES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 22:42

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE Free Beta HCG Control Module

IVDR_67_LLB_DUB-C_C_REAG_Free Beta HCG Control Module

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414953182
Basic UDI-DI: 0405686901480VN
Reference: 10385385
EMDN: W0102152008
EMDN description: CONTROLS FOR INDIVIDUAL AND SPECIFIC HORMONES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 22:42

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE Pyrilinks-D Control Module

IVDR_67_LLB_DUB-C_B_REAG_Pyrilinks-D Control Module

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414953281
Basic UDI-DI: 0405686901435VH
Reference: 10385243
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 22:42

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE Calcitonin Control Module

IVDR_67_LLB_DUB-C_C_REAG_Calcitonin Control Module

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414953120
Basic UDI-DI: 0405686901474VT
Reference: 10385383
EMDN: W0102152008
EMDN description: CONTROLS FOR INDIVIDUAL AND SPECIFIC HORMONES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 22:42

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM C-peptide Calibrator (CpS CAL)

IVDR_67_TTN_DUB-C_B_REAG_C-Peptide Calibrator

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414600420
Basic UDI-DI: 0405686901691W5
Reference: 10995542
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 22:41

Manufacturer products Authorised representative products Authorised representative actors View details