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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

Dimension EXL LOCI N-terminal Pro-Brain Natriuretic Peptide calibrator

IVDR_67_GLA_DUB-C_C_REAG_LOCI NTP CAL

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768026324
Basic UDI-DI: 0405686901276VM
Reference: 10464529
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 00:30

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Creatine Kinase MB Flex reagent cartridge

IVDR_67_GLA_DUB-C_B_REAG_MBI

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768025556
Basic UDI-DI: 0405686901146V7
Reference: 10464510
EMDN: W01010114
EMDN description: CREATINE KINASE - MB ACTIVITY (CC)
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 Barcode Labels

IVDR_67_GLA_DUB-C_A_INST_Barcode Labels

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768024719
Basic UDI-DI: 0405686901009UU
Reference: 10464353
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:30

Manufacturer products Authorised representative products Authorised representative actors View details

Emit® II Plus Ecstasy Assay

IVDR_67_GLA_DUB-C_B_REAG_Ecstasy Assay

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768023460
Basic UDI-DI: 0405686901098VM
Reference: 10445479
EMDN: W0102090102
EMDN description: AMPHETAMINE/METHAMPHETAMINE SPECIFIC
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® II Plus Ethyl Alcohol Assay

IVDR_67_GLA_DUB-C_B_REAG_Ethyl Alcohol Assay

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768023439
Basic UDI-DI: 0405686901107UV
Reference: 10445451
EMDN: W0102090207
EMDN description: ETHANOL (ALCOHOL)
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® II Plus Cocaine Metabolite Assay

IVDR_67_GLA_DUB-C_B_REAG_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: 00842768023415
Basic UDI-DI: 0405686901088VJ
Reference: 10445440
EMDN: W0102090106
EMDN description: COCAINE + COCAINE METABOLITES
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® II Plus Benzodiazepine Assay

IVDR_67_GLA_DUB-C_B_REAG_Benzodiazepine Assay

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768023392
Basic UDI-DI: 0405686901066V8
Reference: 10445432
EMDN: W0102090104
EMDN description: BENZODIAZEPINES
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® II Plus Barbiturate Assay

IVDR_67_GLA_DUB-C_B_REAG_Barbiturate Assay

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768023378
Basic UDI-DI: 0405686901064V4
Reference: 10445425
EMDN: W0102090103
EMDN description: BARBITURATES
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® tox™ Acetaminophen Assay

IVDR_67_GLA_DUB-C_C_REAG_Acetaminophen Assay

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768023330
Basic UDI-DI: 0405686901227V8
Reference: 10445384
EMDN: W0102090201
EMDN description: ACETAMINOPHENE (PARACETAMOL)
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 Gentamicin Plus Assay

IVDR_67_GLA_DUB-C_B_REAG_Gentamicin Plus Assay

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768023316
Basic UDI-DI: 0405686901118V2
Reference: 10445335
EMDN: W0102080307
EMDN description: GENTAMICIN
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 Digoxin Assay

IVDR_67_GLA_DUB-C_C_REAG_Digoxin Assay

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768023255
Basic UDI-DI: 0405686901254VB
Reference: 10445317
EMDN: W0102080101
EMDN description: DIGOXIN
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