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344 device results listed.

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Emit II Plus Cocaine Metabolite Assay

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768014390
Basic UDI-DI: 0405686901088VJ
Reference: 10445438
EMDN: W0102090106
EMDN description: COCAINE + COCAINE METABOLITES
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:35

Manufacturer products Authorised representative products Authorised representative actors View details

Emit II Plus Ethyl Alcohol Assay

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768014413
Basic UDI-DI: 0405686901107UV
Reference: 10445446
EMDN: W0102090207
EMDN description: ETHANOL (ALCOHOL)
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:35

Manufacturer products Authorised representative products Authorised representative actors View details

Emit II Plus Benzodiazepine Assay

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768014376
Basic UDI-DI: 0405686901066V8
Reference: 10445430
EMDN: W0102090104
EMDN description: BENZODIAZEPINES
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:35

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Urine Amphetamine/Methamphetamine Screen Flex reagent cartridge

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768005817
Basic UDI-DI: 0405686900202UH
Reference: 10444926
EMDN: W0102090101
EMDN description: AMPHETAMINES GROUP
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:35

Manufacturer products Authorised representative products Authorised representative actors View details

Emit II Plus Amphetamines Assay

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768001864
Basic UDI-DI: 0405686900202UH
Reference: 10445421
EMDN: W0102090101
EMDN description: AMPHETAMINES GROUP
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:35

Manufacturer products Authorised representative products Authorised representative actors View details

Emit II Plus Ethyl Alcohol Assay

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768002038
Basic UDI-DI: 0405686901107UV
Reference: 10445453
EMDN: W0102090207
EMDN description: ETHANOL (ALCOHOL)
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:35

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Urine Barbiturate Screen Flex reagent cartridge

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768005862
Basic UDI-DI: 0405686901064V4
Reference: 10444918
EMDN: W0102090103
EMDN description: BARBITURATES
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:35

Manufacturer products Authorised representative products Authorised representative actors View details

Emit II Plus Oxycodone Assay

IVDR_67_GLA_DUB-C_B_REAG_Oxycodone Assay

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00630414027920
Basic UDI-DI: 0405686901153V4
Reference: 10720817
EMDN: W0102090123
EMDN description: OXYCODINE
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 05:14

Manufacturer products Authorised representative products Authorised representative actors View details

Emit II Plus Oxycodone Assay

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00630414027937
Basic UDI-DI: 0405686901153V4
Reference: 10720816
EMDN: W0102090123
EMDN description: OXYCODINE
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 06:47

Manufacturer products Authorised representative products Authorised representative actors View details

Emit II Plus Specialty Multi Drug Calibrator/Control Level 4

IVDR_67_GLA_DUB-C_B_REAG_Spl Multi Drug Cals/Ctls Levels 1-4

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00630414027944
Basic UDI-DI: 0405686901901VR
Reference: 10720815
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:32

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension® EXL™ with LM Integrated Chemistry System

IVDR_67_GLA_DUB-C_A_INST_EXL 200 w/LM integrated chem system

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00630414014128
Basic UDI-DI: 0405686902000UH
Reference: 10475506
EMDN: W0201010105
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400)
First on market country: Belgium
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:32

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension EXL™ LOCI Vitamin D Calibrator

IVDR_67_GLA_DUB-C_B_REAG_VITD CAL

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768037764
Basic UDI-DI: 0405686901224V2
Reference: 10711395
EMDN: W0102152206
EMDN description: ANAEMIA RELATED/VITAMIN STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:30

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension EXL LOCI Vitamin D Total Assay Flex reagent cartridge

IVDR_67_GLA_DUB-C_B_REAG_VITD

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768037740
Basic UDI-DI: 0405686901223UY
Reference: 10706480
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:30

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Vista/Dimension EXL Multi 2 Sample Diluent

IVDR_67_GLA_DUB-C_A_REAG_Multi 2 Sample Diluent

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768032417
Basic UDI-DI: 0405686901034UT
Reference: 10483586
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 00:30

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Vista Multi 1 Sample Diluent

IVDR_67_GLA_DUB-C_A_REAG_Multi 1 Sample Diluent

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768030314
Basic UDI-DI: 0405686901033UR
Reference: 10469971
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 00:30

Manufacturer products Authorised representative products Authorised representative actors View details

Emit 2000 Siro/Tacro Sample Pretreatment Reagent

IVDR_67_GLA_DUB-C_C_REAG_Siro.Tacro Sample Pretreatment Reag

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768030048
Basic UDI-DI: 0405686901307V7
Reference: 10488260
EMDN: W0102010114
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IG'S)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:30

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension EXL N-terminal Pro-Brain Natriuretic Peptide Flex reagent cartridge

IVDR_67_GLA_DUB-C_C_REAG_LNTP

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768029929
Basic UDI-DI: 0405686901272VD
Reference: 10464338
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:30

Manufacturer products Authorised representative products Authorised representative actors View details

Emit 2000 Sirolimus Calibrators

IVDR_67_GLA_DUB-C_C_REAG_Sirolimus Calibrators

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768029622
Basic UDI-DI: 0405686901309VB
Reference: 10445402
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 00:30

Manufacturer products Authorised representative products Authorised representative actors View details

Emit 2000 Sirolimus Assay

IVDR_67_GLA_DUB-C_C_REAG_Sirolimus Assay

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768029615
Basic UDI-DI: 0405686901308V9
Reference: 10445401
EMDN: W0102080604
EMDN description: RAPAMYCIN (SIROLIMUS)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:30

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Vista® Small Sample Container (SSC)

IVDR_67_GLA_DUB-C_A_INST_Small Sample Container

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testingSingle use

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768028915
Basic UDI-DI: 0405686901022UL
Reference: 10472099
EMDN: W0599
EMDN description: IVD GENERAL USE CONSUMABLE DEVICES - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:30

Manufacturer products Authorised representative products Authorised representative actors View details