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81 device results listed.

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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 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

IMMULITE 2000 Carbamazepine

IVDR_67_LLB_DUB-C_B_KIT_Carbamazepine

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414961095
Basic UDI-DI: 0405686901373VL
Reference: 10381550
EMDN: W0102080201
EMDN description: CARBAMAZEPINE
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

Atellica CH Gentamicin (Gent)

IVDR_67_TTN_DUB-C_C_REAG_Gentamicin

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414595979
Basic UDI-DI: 0405686901715VS
Reference: 11097516
EMDN: W0102080207
EMDN description: PHENOBARBITAL
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

Atellica CH Phenytoin (Phny)

IVDR_67_TTN_DUB-C_C_REAG_phny

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414596037
Basic UDI-DI: 0405686901761VZ
Reference: 11097510
EMDN: W0102080208
EMDN description: PHENYTOIN
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:34

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica CH Valproic Acid (VPA)

IVDR_67_TTN_DUB-C_C_REAG_VPA

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414596013
Basic UDI-DI: 0405686901904VX
Reference: 11097512
EMDN: W0102080210
EMDN description: VALPROIC ACID
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:34

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica CH Phenobarbital (Phnb)

IVDR_67_TTN_DUB-C_C_REAG_phnb

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414595993
Basic UDI-DI: 0405686901759WE
Reference: 11097514
EMDN: W0102080207
EMDN description: PHENOBARBITAL
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:34

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 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 Phenytoin Flex reagent cartridge

IVDR_67_GLA_DUB-C_B_REAG_PTN

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768005619
Basic UDI-DI: 0405686901170V4
Reference: 10444940
EMDN: W0102080208
EMDN description: PHENYTOIN
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:28

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Phenobarbital Flex reagent cartridge

IVDR_67_GLA_DUB-C_C_REAG_PHNO

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768005596
Basic UDI-DI: 0405686901163V7
Reference: 10444933
EMDN: W0102080207
EMDN description: PHENOBARBITAL
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:28

Manufacturer products Authorised representative products Authorised representative actors View details

Emit Primidone Assay

IVDR_67_GLA_DUB-C_C_REAG_Primidone Assay

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768001376
Basic UDI-DI: 0405686901165VB
Reference: 10445366
EMDN: W0102080209
EMDN description: PRIMIDONE
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:28

Manufacturer products Authorised representative products Authorised representative actors View details

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

IMMULITE 2000 Phenytoin

IVDR_67_LLB_DUB-C_C_KIT_Phenytoin

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414961903
Basic UDI-DI: 0405686901400UW
Reference: 10381548
EMDN: W0102080208
EMDN description: PHENYTOIN
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:26

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE 2000 Phenobarbital

IVDR_67_LLB_DUB-C_C_KIT_phenobarb

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414961828
Basic UDI-DI: 0405686901399W6
Reference: 10381542
EMDN: W0102080207
EMDN description: PHENOBARBITAL
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:25

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica CH Carbamazepine (Carb)

IVDR_67_TTN_DUB-C_B_REAG_Carb

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414595986
Basic UDI-DI: 0405686900775W5
Reference: 11097515
EMDN: W0102080201
EMDN description: CARBAMAZEPINE
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:14

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

IMMULITE 2000 Valproic Acid

IVDR_67_LLB_DUB-C_C_KIT_Valproic Acid

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414962290
Basic UDI-DI: 0405686900228V3
Reference: 10381544
EMDN: W0102080210
EMDN description: VALPROIC ACID
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:03

Manufacturer products Authorised representative products Authorised representative actors View details

VPA Valproate(CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-VPA706-AE6V
Basic UDI-DI: B-VPA706-AE6V
Reference: VPA706-AE10Y, VPA706-AE10N, VPA706-AE20Y, VPA706-AE20N
EMDN: W0102080210
EMDN description: VALPROIC ACID
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 13:24

Manufacturer products Authorised representative products Authorised representative actors View details