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ADVIA Centaur BRAHMS Procalcitonin

IVDR_67_TTN_DUB-C_C_KIT_PCT

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414246536
Basic UDI-DI: 0405686901818W5
Reference: 11202697
EMDN: W0102069013
EMDN description: PROCALCITONIN
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

Atellica CH Tacrolimus (TACR)

IVDR_67_TTN_DUB-C_C_REAG_TACR

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414238340
Basic UDI-DI: 0405686901868WL
Reference: 11097542
EMDN: W0102080603
EMDN description: TACROLIMUS
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

Atellica CI Analyzer

IVDR_67_TTN_DUB-C_A_INST_Atellica CI 1900 Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414229553
Basic UDI-DI: 0405686902224V9
Reference: 10947347
EMDN: W0201030102
EMDN description: MIXED PANEL MULTIPARAMETER ANALYSERS - MODERATE ROUTINE (Throughput > 800 and <= 2000 test/h)
First on market country: Belgium
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:33

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM NT-proBNP (PBNP)

IVDR_67_TTN_DUB-C_C_KIT_PBNP

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414228945
Basic UDI-DI: 0405686901817W3
Reference: 11200588
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
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

Atellica CH Oxycodone (OXY)

IVDR_67_TTN_DUB-C_B_REAG_OXY

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414238098
Basic UDI-DI: 0405686901754W4
Reference: 11097541
EMDN: W0102090123
EMDN description: OXYCODINE
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

Atellica CH Mycophenolic Acid (MPA)

IVDR_67_TTN_DUB-C_C_REAG_MPA

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414238081
Basic UDI-DI: 0405686901857WF
Reference: 11097540
EMDN: W0102080605
EMDN description: MYCOPHENOLATE
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

Atellica CH Procainamide (PROC)

IVDR_67_TTN_DUB-C_C_REAG_Procainamide

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414220673
Basic UDI-DI: 0405686901863WA
Reference: 11097538
EMDN: W0102080107
EMDN description: PROCAINAMIDE
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

Atellica CH N-Acetylprocainamide (NAPA)

IVDR_67_TTN_DUB-C_C_REAG_N-Acetylprocainamide

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414220659
Basic UDI-DI: 0405686901860W4
Reference: 11097537
EMDN: W0102080106
EMDN description: N-ACETYLPROCAINAMIDE
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 Toxo M Quality Control Material

IVDR_67_TTN_DUB-C_C_REAG_Toxo M QC

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414208763
Basic UDI-DI: 0405686901871W9
Reference: 10310326
EMDN: W0105080805
EMDN description: PARASITOLOGY CONTROLS - INF.IMM.
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 Toxoplasma M

IVDR_67_TTN_DUB-C_C_KIT_Toxo M

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414208442
Basic UDI-DI: 0405686901825W2
Reference: 10310320
EMDN: W0105050103
EMDN description: TOXOPLASMA ANTIBODY IGM
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® FT3

IVDR_67_TTN_DUB-C_B_REAG_FT3

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414207520
Basic UDI-DI: 0405686901713VN
Reference: 10310317
EMDN: W01020401
EMDN description: FREE TRIIODOTHYRONINE
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® PSA

IVDR_67_TTN_DUB-C_C_KIT_Prostate-Specific Antigen

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414202990
Basic UDI-DI: 0405686901820VQ
Reference: 10310293
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC 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 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 Rubella M

IVDR_67_TTN_DUB-C_C_REAG_KIT_Rubella M

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414201436
Basic UDI-DI: 0405686901822VU
Reference: 10310285
EMDN: W0105040103
EMDN description: RUBELLA VIRUS IGM
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 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