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ADVIA Centaur Free PSA Calibrator (fPSA Cal)

IVDR_67_TTN_DUB-C_C_REAG_Free PSA Calibrator

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414557748
Basic UDI-DI: 0405686901852W5
Reference: 10361919
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:34

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur Calibrator E

IVDR_67_TTN_DUB-C_B_REAG_CAL E

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414524719
Basic UDI-DI: 0405686901677WB
Reference: 10309079
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:34

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur® Calibrator B

IVDR_67_TTN_DUB-C_C_REAG_Cal B

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414504797
Basic UDI-DI: 0405686901830VT
Reference: 10308986
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:34

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur® H2n Calibrator

IVDR_67_TTN_DUB-C_C_REAG_H2n Cal

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414471228
Basic UDI-DI: 0405686901853W7
Reference: 10308993
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:34

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur AMH QC Kit

IVDR_67_TTN_DUB-C_C_CDx_REAG_AMH QC

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414286914
Basic UDI-DI: 0405686902267VT
Reference: 11205264
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:33

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur BRAHMS Procalcitonin (PCT) Quality Control

IVDR_67_TTN_DUB-C_C_REAG_PCT Quality Control

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414246543
Basic UDI-DI: 0405686901862W8
Reference: 11202698
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:33

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur Calibrator Q (CAL Q)

IVDR_67_TTN_DUB-C_C_REAG_CAL Q

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414202921
Basic UDI-DI: 0405686901832VX
Reference: 10310296
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:32

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur Calibrator C (CAL C)

IVDR_67_TTN_DUB-C_B_REAG_CAL C

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414124919
Basic UDI-DI: 0405686901676W9
Reference: 10311575
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:32

Manufacturer products Authorised representative products Authorised representative actors View details

Emit II Plus Specialty Multi Drug Calibrator/Control Level 4

IVDR_67_GLA_DUB-C_B_REAG_Spl Multi Drug Cals/Ctls Levels 1-4

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00630414027944
Basic UDI-DI: 0405686901901VR
Reference: 10720815
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:32

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur PlGF Quality Control (PlGF QC)

IVDR_67_LLB_DUB-C_C_REAG_PlGF Quality Control

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

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414015606
Basic UDI-DI: 0405686902129VE
Reference: 10998064
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:32

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur sFlt-1 Quality Control (sFlt-1 QC)

IVDR_67_LLB_DUB-C_C_REAG_sFlt-1 Quality Control

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

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414015590
Basic UDI-DI: 0405686902123V2
Reference: 10998063
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:32

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM BRAHMS Procalcitonin Master Curve Material (PCT MCM)

IVDR_67_TTN_DUB-C_C_REAG_Procalcitonin Master Curve Material

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414014197
Basic UDI-DI: 0405686901864WC
Reference: 10998265
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:32

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension EXL™ LOCI Vitamin D Calibrator

IVDR_67_GLA_DUB-C_B_REAG_VITD CAL

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768037764
Basic UDI-DI: 0405686901224V2
Reference: 10711395
EMDN: W0102152206
EMDN description: ANAEMIA RELATED/VITAMIN STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:30

Manufacturer products Authorised representative products Authorised representative actors View details

Emit 2000 Sirolimus Calibrators

IVDR_67_GLA_DUB-C_C_REAG_Sirolimus Calibrators

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768029622
Basic UDI-DI: 0405686901309VB
Reference: 10445402
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:30

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension EXL LOCI N-terminal Pro-Brain Natriuretic Peptide calibrator

IVDR_67_GLA_DUB-C_C_REAG_LOCI NTP CAL

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768026324
Basic UDI-DI: 0405686901276VM
Reference: 10464529
EMDN: W0102152204
EMDN description: CARDIAC MARKER STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:30

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Sirolimus Calibrator

IVDR_67_GLA_DUB-C_C_REAG_SIRO CAL

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768022128
Basic UDI-DI: 0405686901306V5
Reference: 10464327
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:30

Manufacturer products Authorised representative products Authorised representative actors View details

Emit 2000 Phenytoin Calibrators

IVDR_67_GLA_DUB-C_C_REAG_Phenytoin Calibrators

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768017391
Basic UDI-DI: 0405686901162V5
Reference: 10445304
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:29

Manufacturer products Authorised representative products Authorised representative actors View details

Emit tox Serum Tricyclic Antidepressants Calibrator/Controls

IVDR_67_GLA_DUB-C_B_REAG_Serum TCA Calibrator/Controls

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768014321
Basic UDI-DI: 0405686901188VP
Reference: 10445390
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: 16.07.2026 00:29

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Myoglobin Calibrator

IVDR_67_GLA_DUB-C_C_REAG_MYO CAL

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768013720
Basic UDI-DI: 0405686901285VN
Reference: 10445024
EMDN: W0102152204
EMDN description: CARDIAC MARKER STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:29

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension® DRUG Calibrator

IVDR_67_GLA_DUB-C_C_REAG_DRUG CAL

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768005022
Basic UDI-DI: 0405686901260V6
Reference: 10445014
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:28

Manufacturer products Authorised representative products Authorised representative actors View details