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157 device results listed.

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Dimension Vista Empty Flex reagent cartridge

IVDR_67_GLA_DUB-C_A_INST_Empty Flex reagent cartridge

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768015656
Basic UDI-DI: 0405686901013UK
Reference: 10445218
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
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

Emit tox Serum Tricyclic Antidepressants Assay

IVDR_67_GLA_DUB-C_B_REAG_Serum TCA Assay

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768014314
Basic UDI-DI: 0405686901187VM
Reference: 10445389
EMDN: W0102090215
EMDN description: TRICYCLIC ANTIDEPRESSANTS (TOTAL)
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 QuikLYTE Flush Solution

IVDR_67_GLA_DUB-C_A_REAG_QuikLYTE Flush Solution

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768014307
Basic UDI-DI: 0405686901037UZ
Reference: 10445051
EMDN: W0101070302
EMDN description: ELECTROLYTE ELECTRODE BUFFERS AND SOLUTIONS
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® Chemistry Wash

IVDR_67_GLA_DUB-C_A_REAG_Chem Wash

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768014277
Basic UDI-DI: 0405686901027UW
Reference: 10445052
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
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® ALDL Calibrator

IVDR_67_GLA_DUB-C_B_REAG_ALDL CAL

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768014093
Basic UDI-DI: 0405686901058V9
Reference: 10444996
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 00:29

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension® Cuvette Cartridge

IVDR_67_GLA_DUB-C_A_INST_Cuvette Cartridge

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768014086
Basic UDI-DI: 0405686901011UF
Reference: 10445042
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
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 QuikLYTE Dilution Check

IVDR_67_GLA_DUB-C_A_REAG_QuikLYTE Dilution Check

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768014024
Basic UDI-DI: 0405686901036UX
Reference: 10444872
EMDN: W0101070302
EMDN description: ELECTROLYTE ELECTRODE BUFFERS AND SOLUTIONS
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 QuikLYTE Sample Diluent

IVDR_67_GLA_DUB-C_A_REAG_QuikLYTE Sample Diluent

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768014017
Basic UDI-DI: 0405686901038V3
Reference: 10444874
EMDN: W0101070302
EMDN description: ELECTROLYTE ELECTRODE BUFFERS AND SOLUTIONS
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 Flex reagent cartridge

IVDR_67_GLA_DUB-C_C_REAG_MYO

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768013843
Basic UDI-DI: 0405686901284VL
Reference: 10444907
EMDN: W01021304
EMDN description: MYOGLOBIN
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® Reaction Vessels

IVDR_67_GLA_DUB-C_A_INST_Reaction Vessels

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768013928
Basic UDI-DI: 0405686901018UV
Reference: 10445044
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
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 Total Prostate Specific Antigen Flex reagent cartridge

IVDR_67_GLA_DUB-C_C_REAG_TPSA

IVD Class CIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768013874
Basic UDI-DI: 0405686901314V4
Reference: 10444889
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 00:29

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Mass Creatine Kinase MB Isoenzyme Flex reagent cartridge

IVDR_67_GLA_DUB-C_C_REAG_Mass Creatine Kinase MB

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768013829
Basic UDI-DI: 0405686901279VT
Reference: 10444904
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 00:29

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension® IMT Probe Cleaner

IVDR_67_GLA_DUB-C_A_REAG_IMT Probe Cleaner

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768013782
Basic UDI-DI: 0405686901032UP
Reference: 10445038
EMDN: W0101070302
EMDN description: ELECTROLYTE ELECTRODE BUFFERS AND SOLUTIONS
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® Sample Probe Cleaner

IVDR_67_GLA_DUB-C_A_REAG_Sample Probe Cleaner

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768013775
Basic UDI-DI: 0405686901041UQ
Reference: 10445035
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
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® Reagent Probe Cleaner

IVDR_67_GLA_DUB-C_A_REAG_Reagent Probe Cleaner

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768013768
Basic UDI-DI: 0405686901039V5
Reference: 10445036
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
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® Small Sample Container (SSC)

IVDR_67_GLA_DUB-C_A_INST_SSC

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testingSingle use

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768005909
Basic UDI-DI: 0405686901023UN
Reference: 10445040
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
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 Total Iron Binding Capacity (IBCT) Flex reagent cartridge

IVDR_67_GLA_DUB-C_B_REAG_IBCT

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768005756
Basic UDI-DI: 0405686901122UR
Reference: 10444944
EMDN: W01010217
EMDN description: IRON BINDING CAPACITY - TOTAL (CC)
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 Total Protein Flex reagent cartridge

IVDR_67_GLA_DUB-C_B_REAG_TP

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768005671
Basic UDI-DI: 0405686901205UW
Reference: 10444979
EMDN: W01010230
EMDN description: TOTAL PROTEIN
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