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157 device results listed.

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Emit 2000 Valproic Acid Assay

IVDR_67_GLA_DUB-C_C_REAG_Valproic Acid Assay

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768000942
Basic UDI-DI: 0405686901218V7
Reference: 10445312
EMDN: W0102080210
EMDN description: VALPROIC ACID
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:27

Manufacturer products Authorised representative products Authorised representative actors View details

Emit II Plus Methadone Assay

IVDR_67_GLA_DUB-C_B_REAG_Methadone Assay

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768000133
Basic UDI-DI: 0405686901148VB
Reference: 10445426
EMDN: W0102090110
EMDN description: METHADONE
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:27

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension® Sample Diluent

IVDR_67_GLA_DUB-C_A_REAG_Sample Diluent

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768000119
Basic UDI-DI: 0405686901040UN
Reference: 10444875
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 00:27

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension® Purified Water Diluent

IVDR_67_GLA_DUB-C_A_REAG_Purified Water Diluent

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768000096
Basic UDI-DI: 0405686901035UV
Reference: 10444887
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 00:27

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Phosphorus Flex reagent cartridge

IVDR_67_GLA_DUB-C_B_REAG_PHOS

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00630414594484
Basic UDI-DI: 0405686901164V9
Reference: 10720277
EMDN: W01010307
EMDN description: PHOSPHATE INORGANIC / PHOSPHORUS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:23

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension® EXL™ 200 Integrated Chemistry System

IVDR_67_GLA_DUB-C_A_INST_EXL 200 integrated chemistry system

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00630414593579
Basic UDI-DI: 0405686901015UP
Reference: 10636929
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 00:23

Manufacturer products Authorised representative products Authorised representative actors View details

Emit II Plus 6-Acetylmorphine Assay

IVDR_67_GLA_DUB-C_B_REAG_6-Acetylmorphine Assay

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00630414229591
Basic UDI-DI: 0405686901052UV
Reference: 10730975
EMDN: W0102090116
EMDN description: 6-ACETHYLMORPHIUM
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:23

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: 00630414028019
Basic UDI-DI: 0405686901153V4
Reference: 10720808
EMDN: W0102090123
EMDN description: OXYCODINE
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:22

Manufacturer products Authorised representative products Authorised representative actors View details

Emit II Plus Oxycodone Positive Control 300

IVDR_67_GLA_DUB-C_B_REAG_Oxycodone Pos and Neg Controls

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00630414027975
Basic UDI-DI: 0405686901154V6
Reference: 10720812
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:22

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension EXL LOCI High Sensitivity Troponin I Flex Reagent Cartridge

IVDR_67_GLA_DUB-C_C_REAG_TNIH

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768037726
Basic UDI-DI: 0405686900216UU
Reference: 10471068
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:07

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Tacrolimus Calibrator

IVDR_67_GLA_DUB-C_C_REAG_TAC_Cal

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768035432
Basic UDI-DI: 0405686900215US
Reference: 10700796
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 00:07

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Tacrolimus Flex reagent cartridge

IVDR_67_GLA_DUB-C_C_REAG_TAC

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768035425
Basic UDI-DI: 0405686900214UQ
Reference: 10700795
EMDN: W0102080603
EMDN description: TACROLIMUS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:07

Manufacturer products Authorised representative products Authorised representative actors View details

Emit® 2000 Carbamazepine Assay

IVDR_67_GLA_DUB-C_B_REAG_Carbamazepine Assay

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768023231
Basic UDI-DI: 0405686900203UK
Reference: 10445311
EMDN: W0102080201
EMDN description: CARBAMAZEPINE
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:07

Manufacturer products Authorised representative products Authorised representative actors View details

Emit® II Plus Amphetamines Assay

IVDR_67_GLA_DUB-C_B_REAG_Amphetamines Assay

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768023361
Basic UDI-DI: 0405686900202UH
Reference: 10445419
EMDN: W0102090101
EMDN description: AMPHETAMINES GROUP
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:07

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Prealbumin Flex reagent cartridge

IVDR_67_GLA_DUB-C_B_REAG_PALB

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768005725
Basic UDI-DI: 0405686900205UP
Reference: 10444978
EMDN: W0102010305
EMDN description: PRE-ALBUMIN / TRANSTHYRETIN
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:06

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Prealbumin Calibrator

IVDR_67_GLA_DUB-C_B_REAG_PALB_cal

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768005183
Basic UDI-DI: 0405686900206UR
Reference: 10445025
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 00:06

Manufacturer products Authorised representative products Authorised representative actors View details

Emit 2000 Mycophenolic Acid Controls

IVDR_67_GLA_DUB-C_C_REAG_Mycophenolic Acid controls

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768001512
Basic UDI-DI: 0405686900213UN
Reference: 10445381
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 00:06

Manufacturer products Authorised representative products Authorised representative actors View details

Emit 2000 Mycophenolic Acid Calibrators

IVDR_67_GLA_DUB-C_C_REAG_Mycophenolic Acid calibrators

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768001505
Basic UDI-DI: 0405686900212UL
Reference: 10445380
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 00:06

Manufacturer products Authorised representative products Authorised representative actors View details

Emit 2000 Mycophenolic Acid Assay

IVDR_67_GLA_DUB-C_C_REAG_Mycophenolic Acid Assay

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768001499
Basic UDI-DI: 0405686900211UJ
Reference: 10445379
EMDN: W0102080605
EMDN description: MYCOPHENOLATE
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:06

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension EXL LOCI Vitamin B12 Flex reagent cartridge

IVDR_67_GLA_DUB-C_B_REAG_VB12

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00630414976624
Basic UDI-DI: 0405686900207UT
Reference: 10463371
EMDN: W0102070204
EMDN description: VITAMIN B12
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:04

Manufacturer products Authorised representative products Authorised representative actors View details