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879 device results listed.

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Atellica IM Neuron-Specific Enolase (NSE)

IVDR_67_TTN_DUB-C_C_REAG_NSE

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414607191
Basic UDI-DI: 0405686902347VS
Reference: 11354593
EMDN: W0102039007
EMDN description: NEURON SPECIFIC ENOLASE
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 05.08.2026 15:38

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM NSE Calibrator (NSE CAL)

IVDR_67_TTN_DUB-C_C_REAG_NSE CAL

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414607306
Basic UDI-DI: 0405686902348VU
Reference: 11553959
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 05.08.2026 15:38

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur Androstenedione (ANDRO)

IVDR_67_TTN_DUB-C_B_KIT_ANDRO

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414603445
Basic UDI-DI: 0405686901601VA
Reference: 10997290
EMDN: W0102069099
EMDN description: INDIVIDUAL AND SPECIFIC HORMONES - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 05.08.2026 15:38

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur Insulin Diluent

IVDR_67_TTN_DUB-C_A_REAG_IRI_Dil

IVD Class AIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414466200
Basic UDI-DI: 0405686900739VZ
Reference: 10310463
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 05.08.2026 15:38

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur C-Peptide

IVDR_67_TTN_DUB-C_B_KIT_C-Peptide

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414464053
Basic UDI-DI: 0405686901607VN
Reference: 10310448
EMDN: W0102060101
EMDN description: C-PEPTIDE
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 05.08.2026 15:38

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Androstenedione Master Curve Material (ANDRO MCM)

IVDR_67_TTN_DUB-C_B_REAG_ANDRO MCM

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414285559
Basic UDI-DI: 0405686901654VX
Reference: 11200557
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 05.08.2026 15:38

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA 120/2120/2120i TESTpoint Reticulocyte Controls (High)

IVDR_67_TTN_DUB-C_B_REAG_Reticulocyte Control High

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414224442
Basic UDI-DI: 0405686900796WD
Reference: 10312295
EMDN: W0103010506
EMDN description: RETICULOCYTE CONTROLS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 05.08.2026 15:38

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA 2120i without Autosampler

IVDR_67_TTN_DUB-C_B_Inst _No Sample Rack

IVD Class BIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414019796
Basic UDI-DI: 0405686900768W8
Reference: 11219531
EMDN: W0202010102
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 120 samples/hr)
First on market country: Belgium
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 05.08.2026 15:38

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA 2120i with DAA Autosampler

IVDR_67_TTN_DUB-C_B_Inst_Sample Rack

IVD Class BIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414019772
Basic UDI-DI: 0405686900784W6
Reference: 11219529
EMDN: W0202010102
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 120 samples/hr)
First on market country: Belgium
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 05.08.2026 15:38

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica CH 930 Analyzer

IVDR_67_TTN_DUB-C_A_INST_930 Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414651637
Basic UDI-DI: 0405686901510V6
Reference: 11768553
EMDN: W0201010107
EMDN description: CHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (with ISE mode test/h > 800 and <= 1.200)
First on market country: Belgium
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 04.08.2026 20:55

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM 1600 Analyzer

IVDR_67_TTN_DUB-C_A_INST_1600 Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414650623
Basic UDI-DI: 0405686901509VM
Reference: 11764888
EMDN: W0201020103
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h)
First on market country: Belgium
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 04.08.2026 20:55

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM 1300 Analyzer

IVDR_67_TTN_DUB-C_A_INST_1300 Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414650579
Basic UDI-DI: 0405686901508VK
Reference: 11764765
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Belgium
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 04.08.2026 20:55

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM aTPOII Master Curve Material (aTPOII MCM)

IVDR_67_TTN_DUB-C_B_REAG_aTPOII MCM

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414608778
Basic UDI-DI: 0405686902271VJ
Reference: 11203694
EMDN: W0102152211
EMDN description: STANDARDS AND CALIBRATORS FOR AUTOIMMUNITY
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 04.08.2026 20:55

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur NSE Calibrator (NSE CAL)

IVDR_67_TTN_DUB-C_C_REAG_NSE CAL

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414607399
Basic UDI-DI: 0405686902348VU
Reference: 11553958
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 04.08.2026 20:55

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM DHEAS2 Master Curve Material (DHEAS2 MCM)

IVDR_67_TTN_DUB-C_B_REAG_DHEAS2 MCM

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414632940
Basic UDI-DI: 0405686902312V7
Reference: 11209195
EMDN: W0102152008
EMDN description: CONTROLS FOR INDIVIDUAL AND SPECIFIC HORMONES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 04.08.2026 20:55

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur Neuron-Specific Enolase (NSE)

IVDR_67_TTN_DUB-C_C_REAG_NSE

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414607146
Basic UDI-DI: 0405686902347VS
Reference: 11354592
EMDN: W0102039007
EMDN description: NEURON SPECIFIC ENOLASE
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 04.08.2026 20:55

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA 560 Hematology System

IVDR_67_TTN_DUB-C_B_INST_Hematology System

IVD Class BIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414601816
Basic UDI-DI: 0405686901597WC
Reference: 11170842
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Belgium
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 04.08.2026 20:55

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA 560 Control

IVDR_67_TTN_DUB-C_B_REAG_Control

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414600840
Basic UDI-DI: 0405686901690W3
Reference: 11170854
EMDN: W0103010599
EMDN description: HAEMATOLOGY CONTROLS - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 04.08.2026 20:55

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Cyclosporine (CsA)

IVDR_67_TTN_DUB-C_C_CsA

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414598727
Basic UDI-DI: 0405686901807VY
Reference: 10995548
EMDN: W0102080601
EMDN description: CYCLOSPORINE TOTAL
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 04.08.2026 20:55

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA 120/2120/2120i 3 in 1 TESTpoint CSF Controls

IVDR_67_TTN_DUB-C_B_REAG_CSF Controls

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414472539
Basic UDI-DI: 0405686900782W2
Reference: 10314243
EMDN: W0103010599
EMDN description: HAEMATOLOGY CONTROLS - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 04.08.2026 20:55

Manufacturer products Authorised representative products Authorised representative actors View details