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450 device results listed.

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Atellica CH Aspartate Aminotransferase P5P (ASTPLc)

IVDR_67_TTN_DUB-C_B_KIT_ASTP5P

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414009063
Basic UDI-DI: 0405686901604VG
Reference: 11097639
EMDN: W01010110
EMDN description: ASPARTATE AMINO-TRANSFERASE
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:22

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica CH Alanine Aminotransferase P5P (ALTPLc)

IVDR_67_TTN_DUB-C_B_KIT_ALTPLc

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414009056
Basic UDI-DI: 0405686901600V8
Reference: 11097638
EMDN: W01010103
EMDN description: ALANINE AMINO-TRANSFERASE
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:22

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: 00630414007960
Basic UDI-DI: 0405686901508VK
Reference: 11066001
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: 16.07.2026 00:22

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: 00630414002163
Basic UDI-DI: 0405686901510V6
Reference: 11067000
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: 16.07.2026 00:22

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: 00630414002026
Basic UDI-DI: 0405686901509VM
Reference: 11066000
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: 16.07.2026 00:22

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM CA 19-9 Diluent (CA19-9 DIL)

IVDR_67_TTN_DUB-C_A_REAG_CA 19-9_Dil

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414598185
Basic UDI-DI: 0405686900736VT
Reference: 10995491
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 00:14

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Myoglobin (MYO)

IVDR_67_TTN_DUB-C_C_KIT_MYO

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414599663
Basic UDI-DI: 0405686900807VR
Reference: 10995648
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:14

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM B-type Natriuretic Peptide Quality Control (BNP QC)

IVDR_67_TTN_DUB-C_C_REAG_BNP_QC

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414598024
Basic UDI-DI: 0405686900813VL
Reference: 10995475
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:14

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM B‑Type Natriuretic Peptide Calibrator (BNP CAL)

IVDR_67_TTN_DUB-C_C_REAG_BNP_Cal

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414598000
Basic UDI-DI: 0405686900812VJ
Reference: 10995473
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 00:14

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Hepatitis A Total Quality Control (aHAVT QC)

IVDR_67_TTN_DUB-C_B_REAG_aHAVT_QC

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414597782
Basic UDI-DI: 0405686900759W7
Reference: 10995448
EMDN: W0105080802
EMDN description: HEPATITIS VIRUS CONTROLS - INF.IMM.
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:14

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Hepatitis A Total (aHAVT)

IVDR_67_TTN_DUB-C_B_KIT_aHAVT

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414597751
Basic UDI-DI: 0405686900748W2
Reference: 10995446
EMDN: W0105020102
EMDN description: HAV ANTIBODY (TOTAL)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:14

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Hepatitis A IgM Quality Control (aHAVM QC)

IVDR_67_TTN_DUB-C_B_REAG_aHAVM_QC

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414597744
Basic UDI-DI: 0405686900758W5
Reference: 10995445
EMDN: W0105080802
EMDN description: HEPATITIS VIRUS CONTROLS - INF.IMM.
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:14

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica CH CHEM III Calibrator (CHEM III CAL)

IVDR_67_TTN_DUB-C_B_REAG_CHEM III_Cal

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414597379
Basic UDI-DI: 0405686900777W9
Reference: 11099335
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:14

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica CH Alkaline Phosphatase_2 Calibrator (ALP_2 CAL)

IVDR_67_TTN_DUB-C_B_REAG_ALP_2_Cal

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414597218
Basic UDI-DI: 0405686900762VU
Reference: 11099316
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:14

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica CH Albumin BCP Calibrator (AlbP CAL)

IVDR_67_TTN_DUB-C_B_REAG_ALBP_Cal

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414597201
Basic UDI-DI: 0405686900761VS
Reference: 11099310
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:14

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica CH A-LYTE Integrated Multisensor (IMT Na K Cl)

IVDR_67_TTN_DUB-C_C_REAG_IMT Na K Cl

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414596518
Basic UDI-DI: 0405686900822VM
Reference: 11099315
EMDN: W0101070199
EMDN description: ELECTROLYTE ELECTRODES - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:14

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica CH Glucose Hexokinase_3 (GluH_3)

IVDR_67_TTN_DUB-C_C_REAG_GLUH_3

IVD Class CIVDR 2017/746On the marketMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414596488
Basic UDI-DI: 0405686900818VW
Reference: 11097592
EMDN: W01010213
EMDN description: GLUCOSE
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:14

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica CH Urea Nitrogen (UN_c)

IVDR_67_TTN_DUB-C_B_REAG_UN_c

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414596471
Basic UDI-DI: 0405686900803VH
Reference: 11097593
EMDN: W01010204
EMDN description: UREA/BLOOD UREA NITROGEN
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:14

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica CH Alkaline Phosphatase, Concentrated (ALP_2c)

IVDR_67_TTN_DUB-C_B_REAG_ALP_2c

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414596419
Basic UDI-DI: 0405686900763VW
Reference: 11097600
EMDN: W01010105
EMDN description: ALKALINE PHOSPHATASE - TOTAL
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:14

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica CH Amphetamines (Amp)

IVDR_67_TTN_DUB-C_B_REAG_Amp

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414596068
Basic UDI-DI: 0405686900766W4
Reference: 11097506
EMDN: W0102090101
EMDN description: AMPHETAMINES GROUP
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:14

Manufacturer products Authorised representative products Authorised representative actors View details