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157 device results listed.

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Dimension Triglycerides Flex reagent cartridge

IVDR_67_GLA_DUB-C_B_REAG_TRIG

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768005657
Basic UDI-DI: 0405686901207V2
Reference: 10444906
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 00:28

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Phenytoin Flex reagent cartridge

IVDR_67_GLA_DUB-C_B_REAG_PTN

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768005619
Basic UDI-DI: 0405686901170V4
Reference: 10444940
EMDN: W0102080208
EMDN description: PHENYTOIN
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:28

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Phenobarbital Flex reagent cartridge

IVDR_67_GLA_DUB-C_C_REAG_PHNO

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768005596
Basic UDI-DI: 0405686901163V7
Reference: 10444933
EMDN: W0102080207
EMDN description: PHENOBARBITAL
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:28

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Tobramycin Flex reagent cartridge

IVDR_67_GLA_DUB-C_C_REAG_TOBR

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768005381
Basic UDI-DI: 0405686901202UQ
Reference: 10444928
EMDN: W0102080317
EMDN description: TOBRAMYCIN
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:28

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Lithium Flex reagent cartridge

IVDR_67_GLA_DUB-C_C_REAG_LITH

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768005367
Basic UDI-DI: 0405686901136V4
Reference: 10444939
EMDN: W01010305
EMDN description: LITHIUM
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:28

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Automated LDL Cholesterol Flex Reagent Cartridge

IVDR_67_GLA_DUB-C_B_REAG_LDLC

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768005350
Basic UDI-DI: 0405686901131US
Reference: 10444890
EMDN: W01010221
EMDN description: LOW DENSITY LIPOPROTEIN CHOLESTEROL INCLUDING SD-LDL
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:28

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Total Iron Binding Capacity (IBCT) Calibrator

IVDR_67_GLA_DUB-C_B_REAG_IBCT CAL

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768005206
Basic UDI-DI: 0405686901123UT
Reference: 10445006
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 00:28

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension® Special Protein Calibrator

IVDR_67_GLA_DUB-C_B_REAG_SP CAL

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768005190
Basic UDI-DI: 0405686901189VR
Reference: 10445028
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:28

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension® DRUG Calibrator

IVDR_67_GLA_DUB-C_C_REAG_DRUG CAL

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768005022
Basic UDI-DI: 0405686901260V6
Reference: 10445014
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:28

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension® Aliquot Wheel Assembly

IVDR_67_GLA_DUB-C_A_INST_Aliquot Wheel Assembly

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768004865
Basic UDI-DI: 0405686901008US
Reference: 10445043
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:28

Manufacturer products Authorised representative products Authorised representative actors View details

Emit II Plus Methaqualone Assay

IVDR_67_GLA_DUB-C_B_REAG_Methaqualone Assay

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768002205
Basic UDI-DI: 0405686901149VD
Reference: 10445473
EMDN: W0102090111
EMDN description: METHAQUALONE
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:28

Manufacturer products Authorised representative products Authorised representative actors View details

Emit II Plus Cannabinoid Assay

IVDR_67_GLA_DUB-C_B_REAG_Cannabinoid Assay

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768002182
Basic UDI-DI: 0405686901075V9
Reference: 10445469
EMDN: W0102090105
EMDN description: CANNABINOIDS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:28

Manufacturer products Authorised representative products Authorised representative actors View details

Emit LSD Control Level 1

IVDR_67_GLA_DUB-C_B_REAG_LSD Controls

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768002090
Basic UDI-DI: 0405686901143UZ
Reference: 10445460
EMDN: W0102152009
EMDN description: CONTROLS FOR NARCOTICS / TOXICOLOGY
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:28

Manufacturer products Authorised representative products Authorised representative actors View details

Emit LSD 1.5 ng/mL Calibrator

IVDR_67_GLA_DUB-C_B_REAG_LSD Calibrators

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768002076
Basic UDI-DI: 0405686901142UX
Reference: 10445457
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 00:28

Manufacturer products Authorised representative products Authorised representative actors View details

Emit II Plus Phencyclidine Assay

IVDR_67_GLA_DUB-C_B_REAG_Phencyclidine Assay

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768001956
Basic UDI-DI: 0405686901158VE
Reference: 10445441
EMDN: W0102090114
EMDN description: PHENCYCLIDINE
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:28

Manufacturer products Authorised representative products Authorised representative actors View details

Emit II Plus Propoxyphene Assay

IVDR_67_GLA_DUB-C_B_REAG_Propoxyphene Assay

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768001918
Basic UDI-DI: 0405686901169VK
Reference: 10445433
EMDN: W0102090115
EMDN description: PROPOXYPHENE
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:28

Manufacturer products Authorised representative products Authorised representative actors View details

Emit II Plus Opiate Assay

IVDR_67_GLA_DUB-C_B_REAG_Opiate Assay

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768001819
Basic UDI-DI: 0405686901152V2
Reference: 10445416
EMDN: W0102090113
EMDN description: OPIATES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:28

Manufacturer products Authorised representative products Authorised representative actors View details

Emit 2000 Tacrolimus Calibrators

IVDR_67_GLA_DUB-C_C_REAG_Tacrolimus Calibrators

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768001680
Basic UDI-DI: 0405686901311UW
Reference: 10445399
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:28

Manufacturer products Authorised representative products Authorised representative actors View details

Emit 2000 Tacrolimus Assay

IVDR_67_GLA_DUB-C_C_REAG_Tacrolimus Assay

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768001666
Basic UDI-DI: 0405686901310UU
Reference: 10445397
EMDN: W0102080603
EMDN description: TACROLIMUS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:28

Manufacturer products Authorised representative products Authorised representative actors View details

Emit Calibrator/Control Level 2

IVDR_67_GLA_DUB-C_B_REAG_Calibrator/Control

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768001758
Basic UDI-DI: 0405686901074V7
Reference: 10445408
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 00:28

Manufacturer products Authorised representative products Authorised representative actors View details