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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

Dimension Sirolimus Calibrator

IVDR_67_GLA_DUB-C_C_REAG_SIRO CAL

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768022128
Basic UDI-DI: 0405686901306V5
Reference: 10464327
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

Dimension Sirolimus Flex reagent cartridge

IVDR_67_GLA_DUB-C_C_REAG_SIRO

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768022111
Basic UDI-DI: 0405686901305V3
Reference: 10464331
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 LOCI Thyroid Stimulating Hormone Flex reagent cartridge

IVDR_67_GLA_DUB-C_B_REAG_Thyroid Stimulating Hormone

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768022081
Basic UDI-DI: 0405686901199VU
Reference: 10464524
EMDN: W01020410
EMDN description: THYROID STIMULATING HORMONE
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 Total Bilirubin Flex reagent cartridge

IVDR_67_GLA_DUB-C_B_REAG_TBI

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768020544
Basic UDI-DI: 0405686901192VE
Reference: 10444957
EMDN: W01010203
EMDN description: BILIRUBIN
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 LSD Assay

IVDR_67_GLA_DUB-C_B_REAG_LSD Assay

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768020315
Basic UDI-DI: 0405686901141UV
Reference: 10445455
EMDN: W0102090109
EMDN description: LYSERGIC ACID DIETHYLAMIDE
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 N-Acetylprocainamide Assay

IVDR_67_GLA_DUB-C_C_REAG_N-Acetylprocainamide Assay

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768017421
Basic UDI-DI: 0405686901287VS
Reference: 10445321
EMDN: W0102080106
EMDN description: N-ACETYLPROCAINAMIDE
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 Phenobarbital Assay

IVDR_67_GLA_DUB-C_C_REAG_Phenobarbital Assay

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768017407
Basic UDI-DI: 0405686901159VG
Reference: 10445306
EMDN: W0102080207
EMDN description: PHENOBARBITAL
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 2000 Phenytoin Calibrators

IVDR_67_GLA_DUB-C_C_REAG_Phenytoin Calibrators

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768017391
Basic UDI-DI: 0405686901162V5
Reference: 10445304
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 00:29

Manufacturer products Authorised representative products Authorised representative actors View details

Emit 2000 Phenytoin Assay

IVDR_67_GLA_DUB-C_C_REAG_Phenytoin Assay

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768017384
Basic UDI-DI: 0405686901161V3
Reference: 10445303
EMDN: W0102080208
EMDN description: PHENYTOIN
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 Vista® Empty Vials Kit

IVDR_67_GLA_DUB-C_A_INST_Empty Vials Kit

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testingSingle use

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768016295
Basic UDI-DI: 0405686901014UM
Reference: 10445213
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

Dimension Vista LOCI Reaction Vessel

IVDR_67_GLA_DUB-C_A_INST_LOCI Reaction Vessel

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testingSingle use

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768016288
Basic UDI-DI: 0405686901016UR
Reference: 10445212
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 Vista Cuvettes (CUV)

IVDR_67_GLA_DUB-C_A_INST_CUV

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768016271
Basic UDI-DI: 0405686901010UD
Reference: 10445211
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

Dimension Vista® Aliquot Plates

IVDR_67_GLA_DUB-C_A_INST_Aliquot Plates

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testingSingle use

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768016264
Basic UDI-DI: 0405686901007UQ
Reference: 10445210
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

Dimension Vista V-LYTE Dilution Check

IVDR_67_GLA_DUB-C_A_REAG_V-LYTE Dilution Check

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768016257
Basic UDI-DI: 0405686901045UY
Reference: 10445203
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (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 Vista V-LYTE Diluent

IVDR_67_GLA_DUB-C_A_REAG_V-LYTE Diluent

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768016240
Basic UDI-DI: 0405686901044UW
Reference: 10445202
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (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 CardioPhase high sensitivity CRP Flex reagent cartridge

IVDR_67_GLA_DUB-C_C_REAG_CCRP

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768016028
Basic UDI-DI: 0405686901077VD
Reference: 10444897
EMDN: W01021109
EMDN description: C-REACTIVE 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