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ADVIA Centaur Rub G quality control material

IVDR_67_TTN_DUB-C_C_REAG_Rub G QC

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414201429
Basic UDI-DI: 0405686902037V8
Reference: 10310284
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
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 Rubella G assay

IVDR_67_TTN_DUB-C_C_REAG_Rub G assay

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414201412
Basic UDI-DI: 0405686902036V6
Reference: 10310283
EMDN: W0105040102
EMDN description: RUBELLA VIRUS IGG
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® CKMB

IVDR_67_TTN_DUB-C_C_KIT_CKMB

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414177434
Basic UDI-DI: 0405686901804VS
Reference: 10309982
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
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® AFP

IVDR_67_TTN_DUB-C_C_KIT_Alpha Fetoprotein

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414177328
Basic UDI-DI: 0405686901798WQ
Reference: 10309979
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
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® CEA

IVDR_67_TTN_DUB-C_C_KIT_CEA

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414177304
Basic UDI-DI: 0405686901803VQ
Reference: 10309977
EMDN: W0102030112
EMDN description: CARCINOEMBRYONIC ANTIGEN
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® VB12

IVDR_67_TTN_DUB-C_B_KIT_VB12

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414177168
Basic UDI-DI: 0405686901638VZ
Reference: 10309970
EMDN: W0102070204
EMDN description: VITAMIN B12
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® Tup

IVDR_67_TTN_DUB-C_B_KIT_TUp

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414177120
Basic UDI-DI: 0405686901635VT
Reference: 10309966
EMDN: W01020406
EMDN description: T- UPTAKE
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® T4

IVDR_67_TTN_DUB-C_B_KIT_T4

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414177045
Basic UDI-DI: 0405686901628VW
Reference: 10309960
EMDN: W01020407
EMDN description: THYROXINE
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® TSH

IVDR_67_TTN_DUB-C_B_KIT_TSH

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414177038
Basic UDI-DI: 0405686901632VM
Reference: 10309959
EMDN: W01020410
EMDN description: THYROID STIMULATING HORMONE
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® T3/T4/VB12 Ancillary Reagent

IVDR_67_TTN_DUB-C_B_REAG_T3/T4/VB12 Ancillary Reagent

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414175379
Basic UDI-DI: 0405686901772W6
Reference: 10319315
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
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® CKMB Diluent

IVDR_67_TTN_DUB-C_A_REAG_CKMB Diluent

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414175324
Basic UDI-DI: 0405686901902VT
Reference: 10309951
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
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

Deproteinizer

IVDR_69_TTN_DUB-C_A_NPT_REAG_BG-RL1200/348EX_CP

IVD Class AIVDR 2017/746On the marketNear-patient testingProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414055909
Basic UDI-DI: 0405686901922VZ
Reference: 10309775
EMDN: W0201040185
EMDN description: BLOOD GAS ANALYSERS - CONSUMABLES
First on market country: Belgium
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

ADVIA Centaur Soluble fms-like Tyrosine Kinase-1 (sFlt-1)

IVDR_67_LLB_DUB-C_C_REAG_Soluble fms-like Tyrosine Kinase-1

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

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414015583
Basic UDI-DI: 0405686902122UY
Reference: 10997829
EMDN: W0102050212
EMDN description: SOLUBLE FMS-LIKE TYROSINE KINASE-1
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™ with LM Integrated Chemistry System

IVDR_67_GLA_DUB-C_A_INST_EXL 200 w/LM integrated chem system

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00630414014128
Basic UDI-DI: 0405686902000UH
Reference: 10475506
EMDN: W0201010105
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400)
First on market country: Belgium
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 Autoslide® Slide Maker Stainer

IVDR_67_TTN_DUB-C_A_INST_Autoslide Slide Maker Stainer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testingSingle use

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414000220
Basic UDI-DI: 0405686901977WS
Reference: 10282178
EMDN: W0202059002
EMDN description: AUTOMATED SLIDE STAINERS
First on market country: Belgium
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:32

Manufacturer products Authorised representative products Authorised representative actors View details