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379 device results listed.

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Emit 2000 Digoxin Calibrators

IVDR_67_GLA_DUB-C_C_REAG_Digoxin Calibrators

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768000973
Basic UDI-DI: 0405686901255VD
Reference: 10445316
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:41

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: 00842768000966
Basic UDI-DI: 0405686901254VB
Reference: 10445315
EMDN: W0102080201
EMDN description: CARBAMAZEPINE
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:41

Manufacturer products Authorised representative products Authorised representative actors View details

Emit 2000 Carbamazepine Calibrators

IVDR_67_GLA_DUB-C_B_REAG_Carbamazepine Calibrators

IVD Class CIVDR 2017/746On the marketMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768000935
Basic UDI-DI: 0405686901076VB
Reference: 10445310
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:41

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: 00842768000928
Basic UDI-DI: 0405686900203UK
Reference: 10445309
EMDN: W0102080201
EMDN description: CARBAMAZEPINE
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:41

Manufacturer products Authorised representative products Authorised representative actors View details

Emit Ethosuximide Assay

IVDR_67_GLA_DUB-C_C_REAG_Ethosuximide Assay

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768000140
Basic UDI-DI: 0405686901105UR
Reference: 10445367
EMDN: W0102080202
EMDN description: ETHOSUXIMIDE
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:41

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Chemistry I Calibrator

IVDR_67_GLA_DUB-C_C_REAG_Chemistry I Calibrator

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00630414948492
Basic UDI-DI: 0405686901241V2
Reference: 10716280
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:40

Manufacturer products Authorised representative products Authorised representative actors View details

Emit II Plus Buprenorphine Assay

IVDR_67_GLA_DUB-C_B_REAG_Buprenorphine Assay

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00630414601113
Basic UDI-DI: 0405686901069VE
Reference: 10720047
EMDN: W0102090117
EMDN description: BUPRENORPHINE
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:40

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Creatinine Flex reagent cartridge

IVDR_67_GLA_DUB-C_C_REAG_CREA2

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00630414595009
Basic UDI-DI: 0405686902016UY
Reference: 10872079
EMDN: W01010207
EMDN description: CREATININE
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:39

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension EXL LOCI BRAHMS Procalcitonin Calibrator (PCT CAL)

IVDR_67_GLA_DUB-C_C_REAG_LOCI PCT CAL

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00630414238708
Basic UDI-DI: 0405686902023UV
Reference: 11354448
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:39

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension EXL LOCI BRAHMS Procalcitonin (PCT)

IVDR_67_GLA_DUB-C_C_REAG_LOCI PCT

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00630414238692
Basic UDI-DI: 0405686902022UT
Reference: 11354447
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:39

Manufacturer products Authorised representative products Authorised representative actors View details

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: 00842768001949
Basic UDI-DI: 0405686901088VJ
Reference: 10445439
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 Benzodiazepine Assay

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768001901
Basic UDI-DI: 0405686901066V8
Reference: 10445431
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

Emit II Plus Barbiturate Assay

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768014352
Basic UDI-DI: 0405686901064V4
Reference: 10445423
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 Barbiturate Assay

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768001888
Basic UDI-DI: 0405686901064V4
Reference: 10445424
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 Amphetamines Assay

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768014345
Basic UDI-DI: 0405686900202UH
Reference: 10445418
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 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