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342 device results listed.

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Emit Ethyl Alcohol Low Control

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768001987
Basic UDI-DI: 0405686901108UX
Reference: 10445447
EMDN: W0102152209
EMDN description: DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 22:36

Manufacturer products Authorised representative products Authorised representative actors View details

Emit Ethyl Alcohol High Control

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768002007
Basic UDI-DI: 0405686901108UX
Reference: 10445449
EMDN: W0102152209
EMDN description: DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 22:36

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Alkaline Phosphatase Flex reagent cartridge

IVDR_67_GLA_DUB-C_B_REAG_ALPI

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768039010
Basic UDI-DI: 0405686900198VK
Reference: 10642445
EMDN: W01010105
EMDN description: ALKALINE PHOSPHATASE - TOTAL
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 03:20

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Alanine Aminotransferase Flex reagent cartridge

IVDR_67_GLA_DUB-C_B_REAG_ALTI

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768034336
Basic UDI-DI: 0405686901059VB
Reference: 10475530
EMDN: W01010103
EMDN description: ALANINE AMINO-TRANSFERASE
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 03:20

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Enzyme II Calibrator

IVDR_67_GLA_DUB-C_B_REAG_Enzyme II Calibrator

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768034329
Basic UDI-DI: 0405686901103UM
Reference: 10476170
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 03:19

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension CHK Flex reagent cartridge

IVDR_67_GLA_DUB-C_A_REAG_CHK

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768033124
Basic UDI-DI: 0405686901028UY
Reference: 10481507
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 03:19

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension EXL LOCI Free Triiodothyronine Flex reagent cartridge

IVDR_67_GLA_DUB-C_B_REAG_Free Triiodothyronine

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768032622
Basic UDI-DI: 0405686901115UU
Reference: 10483414
EMDN: W01020401
EMDN description: FREE TRIIODOTHYRONINE
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 03:19

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension LOCI Thyroid Calibrator

IVDR_67_GLA_DUB-C_B_REAG_LOCI THYR CAL

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768031694
Basic UDI-DI: 0405686901140UT
Reference: 10484354
EMDN: W0102152202
EMDN description: HORMONE STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 03:19

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Ethyl alcohol Flex reagent cartridge

IVDR_67_GLA_DUB-C_B_REAG_Ethyl alcohol

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768022050
Basic UDI-DI: 0405686901106UT
Reference: 10459408
EMDN: W0102090207
EMDN description: ETHANOL (ALCOHOL)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 03:19

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Automated HDL Cholesterol Flex reagent cartridge

IVDR_67_GLA_DUB-C_B_REAG_HDLC

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768022029
Basic UDI-DI: 0405686901121UP
Reference: 10464332
EMDN: W01010215
EMDN description: HIGH DENSITY LIPOPROTEIN CHOLESTEROL
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 03:19

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension AHDL Calibrator

IVDR_67_GLA_DUB-C_B_REAG_AHDL CAL

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768022012
Basic UDI-DI: 0405686901055V3
Reference: 10464328
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 03:19

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Iron Flex reagent cartridge

IVDR_67_GLA_DUB-C_B_REAG_IRON

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768020414
Basic UDI-DI: 0405686901127V3
Reference: 10444945
EMDN: W01010216
EMDN description: IRON (CC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 03:19

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Bilirubin Calibrator

IVDR_67_GLA_DUB-C_B_REAG_DBI CAL

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768016813
Basic UDI-DI: 0405686901094VD
Reference: 10445013
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 03:19

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Vista Sample Probe Cleaner

IVDR_67_GLA_DUB-C_A_REAG_Small Probe Cleaner

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768016356
Basic UDI-DI: 0405686901042US
Reference: 10445209
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 03:19

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Vista Cuvette Wash Solution

IVDR_67_GLA_DUB-C_A_REAG_Cuvette Wash Solution

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768016332
Basic UDI-DI: 0405686901030UK
Reference: 10445207
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 03:19

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Vista System Diluent

IVDR_67_GLA_DUB-C_A_REAG_System Diluent

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768016325
Basic UDI-DI: 0405686901043UU
Reference: 10445206
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 03:19

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Vista/Dimension EXL CTNI Sample Diluent

IVDR_67_GLA_DUB-C_A_REAG_CTNI SDIL

IVD Class AIVDR 2017/746On the marketHuman tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768015892
Basic UDI-DI: 0405686901029V2
Reference: 10445205
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 03:19

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Sample Transfer Module Aliquot Segment

IVDR_67_GLA_DUB-C_A_INST_Sample Transfer Mod Aliquot Segment

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768014048
Basic UDI-DI: 0405686901020UG
Reference: 10445571
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 03:19

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Sample Transfer Module Pipette Tips

IVDR_67_GLA_DUB-C_A_INST_Sample Transfer Module Pipette Tips

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768014031
Basic UDI-DI: 0405686901021UJ
Reference: 10445570
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 03:19

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Ferritin Flex reagent cartridge

IVDR_67_GLA_DUB-C_B_REAG_FERR

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768013867
Basic UDI-DI: 0405686901111UL
Reference: 10444946
EMDN: W0102070102
EMDN description: FERRITIN
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 03:19

Manufacturer products Authorised representative products Authorised representative actors View details