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492 device results listed.

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Emit Lidocaine Assay

IVDR_67_GLA_DUB-C_C_KIT_Lidocaine Assay

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768001390
Basic UDI-DI: 0405686901226V6
Reference: 10445369
EMDN: W0102080105
EMDN description: LIDOCAINE
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 Methotrexate Assay

IVDR_67_GLA_DUB-C_C_KIT_Methotrexate Assay

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768001383
Basic UDI-DI: 0405686901051UT
Reference: 10445368
EMDN: W0102080501
EMDN description: METHOTREXATE
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 Vancomycin Assay

IVDR_67_GLA_DUB-C_C_REAG_Vancomycin Assay

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768001109
Basic UDI-DI: 0405686901221UU
Reference: 10445336
EMDN: W0102080319
EMDN description: VANCOMYCIN
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 2000 Tobramycin Assay

IVDR_67_GLA_DUB-C_B_REAG_Tobramycin Assay

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768001062
Basic UDI-DI: 0405686901203US
Reference: 10445330
EMDN: W0102080317
EMDN description: TOBRAMYCIN
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 2000 Quinidine Assay

IVDR_67_GLA_DUB-C_C_REAG_Quinidine Assay

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768001048
Basic UDI-DI: 0405686901298VX
Reference: 10445327
EMDN: W0102080109
EMDN description: QUINIDINE
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 2000 Theophylline Assay

IVDR_67_GLA_DUB-C_C_REAG_Theophylline Assay

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768001024
Basic UDI-DI: 0405686901196VN
Reference: 10445324
EMDN: W0102080402
EMDN description: THEOPHYLLINE
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 2000 Procainamide Assay

IVDR_67_GLA_DUB-C_C_REAG_Procainamide Assay

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768000980
Basic UDI-DI: 0405686901293VM
Reference: 10445318
EMDN: W0102080107
EMDN description: PROCAINAMIDE
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 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 Theophylline

IVDR_67_LLB_DUB-C_B_KIT_Theophylne

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

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414966311
Basic UDI-DI: 0405686901407VC
Reference: 10381539
EMDN: W0102080402
EMDN description: THEOPHYLLINE
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 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

Atellica CH Lidocaine (LIDO)

IVDR_67_TTN_DUB-C_C_REAG_Lido

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414220680
Basic UDI-DI: 0405686900828VZ
Reference: 11097539
EMDN: W0102080105
EMDN description: LIDOCAINE
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:13

Manufacturer products Authorised representative products Authorised representative actors View details

Emit 2000 Mycophenolic Acid Assay

IVDR_67_LLB_DUB-C_C_REAG_Mycophenolic Acid

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

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414168265
Basic UDI-DI: 0405686900731VH
Reference: 10730958
EMDN: W0102080605
EMDN description: MYCOPHENOLATE
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:12

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 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

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