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84 device results listed.

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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

PHT Phenytoin(CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-PHT706-AE7W
Basic UDI-DI: B-PHT706-AE7W
Reference: PHT706-AE10Y, PHT706-AE10N, PHT706-AE20Y, PHT706-AE20N
EMDN: W0102080208
EMDN description: PHENYTOIN
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 09:45

Manufacturer products Authorised representative products Authorised representative actors View details

PB Phenobarbital(CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-PB706-AE3D
Basic UDI-DI: B-PB706-AE3D
Reference: PB706-AE10Y, PB706-AE10N, PB706-AE20Y, PB706-AE20N
EMDN: W0102080207
EMDN description: PHENOBARBITAL
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 06:32

Manufacturer products Authorised representative products Authorised representative actors View details

ClinMass®

MS9400

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: RECIPE Chemicals + Instruments GmbH
Manufacturer SRN: DE-MF-000032553
UDI-DI: D-MS9400CF
Basic UDI-DI: B-MS9400CF
Reference: MS9400
EMDN: W0102080299
EMDN description: CENTRAL NERVOUS SYSTEM TDM - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 14.07.2026 05:16

Manufacturer products View details

ClinMass®

MS9300

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: RECIPE Chemicals + Instruments GmbH
Manufacturer SRN: DE-MF-000032553
UDI-DI: D-MS9300CA
Basic UDI-DI: B-MS9300CA
Reference: MS9300
EMDN: W0102080299
EMDN description: CENTRAL NERVOUS SYSTEM TDM - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 14.07.2026 05:16

Manufacturer products View details

ClinMass®

MS9200

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: RECIPE Chemicals + Instruments GmbH
Manufacturer SRN: DE-MF-000032553
UDI-DI: D-MS9200C5
Basic UDI-DI: B-MS9200C5
Reference: MS9200
EMDN: W0102080299
EMDN description: CENTRAL NERVOUS SYSTEM TDM - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 14.07.2026 05:16

Manufacturer products View details

ClinMass®

MS9100

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: RECIPE Chemicals + Instruments GmbH
Manufacturer SRN: DE-MF-000032553
UDI-DI: D-MS9100BY
Basic UDI-DI: B-MS9100BY
Reference: MS9100
EMDN: W0102080299
EMDN description: CENTRAL NERVOUS SYSTEM TDM - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 14.07.2026 05:16

Manufacturer products View details

GAB Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-DGAB-R102TF
Basic UDI-DI: B-DGAB-R102TF
Reference: DGAB-R102
EMDN: W0102080211
EMDN description: GABAPENTIN
First on market country: Spain
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.07.2026 17:08

Manufacturer products Authorised representative products Authorised representative actors View details

CBZ Carbamazepine(CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-CBZ706-AEW4
Basic UDI-DI: B-CBZ706-AEW4
Reference: CBZ706-AE10Y, CBZ706-AE10N, CBZ706-AE20Y, CBZ706-AE20N
EMDN: W0102080201
EMDN description: CARBAMAZEPINE
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 03:55

Manufacturer products Authorised representative products Authorised representative actors View details

D-811026P3

S100β Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024153
UDI-DI: D-811026P3
Basic UDI-DI: B-811026P3
Reference: 811026
EMDN: W0102080299
EMDN description: CENTRAL NERVOUS SYSTEM TDM - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 09:57

Manufacturer products Authorised representative products Authorised representative actors View details

Phenobarbital Reagent (PHE 2 x 100)

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-469785SH
Basic UDI-DI: B-469785SH
Reference: 469785
EMDN: W0102080207
EMDN description: PHENOBARBITAL
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:54

Manufacturer products Authorised representative products Authorised representative actors View details

Phenytoin Reagent (PHY 2 x 100)

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-469188RR
Basic UDI-DI: B-469188RR
Reference: 469188
EMDN: W0102080208
EMDN description: PHENYTOIN
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:54

Manufacturer products Authorised representative products Authorised representative actors View details

Carbamazepine Reagent

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-469112QQ
Basic UDI-DI: B-469112QQ
Reference: 469112
EMDN: W0102080201
EMDN description: CARBAMAZEPINE
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:54

Manufacturer products Authorised representative products Authorised representative actors View details

Valproic Acid Reagent (VPA 2 x 100)

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-467995SG
Basic UDI-DI: B-467995SG
Reference: 467995
EMDN: W0102080206
EMDN description: FREE VALPROIC ACID
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:53

Manufacturer products Authorised representative products Authorised representative actors View details

Valproic Acid Reagent Set

4220 P VPA

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Diagnotix B.V.
Manufacturer SRN: NL-MF-000000236
UDI-DI: D-4220PVPAN5
Basic UDI-DI: B-4220PVPAN5
Reference: 4220 P VPA
EMDN: W0102080210
EMDN description: VALPROIC ACID
First on market country: Netherlands
Authorised representative: -
Last updated: 11.07.2026 19:16

Manufacturer products View details

Anti-Epileptic Drugs Expanded Panel Reagent Set

4030 P AEDX

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Diagnotix B.V.
Manufacturer SRN: NL-MF-000000236
UDI-DI: D-4030PAEDX4T
Basic UDI-DI: B-4030PAEDX4T
Reference: 4030 P AEDX
EMDN: W0102080299
EMDN description: CENTRAL NERVOUS SYSTEM TDM - OTHER
First on market country: Netherlands
Authorised representative: -
Last updated: 11.07.2026 19:07

Manufacturer products View details

Anti-Epileptic Drugs Basic Panel Reagent Set

4010 P AED

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Diagnotix B.V.
Manufacturer SRN: NL-MF-000000236
UDI-DI: D-4010PAEDGJ
Basic UDI-DI: B-4010PAEDGJ
Reference: 4010 P AED
EMDN: W0102080299
EMDN description: CENTRAL NERVOUS SYSTEM TDM - OTHER
First on market country: Netherlands
Authorised representative: -
Last updated: 11.07.2026 19:05

Manufacturer products View details

ClinRep®

15500

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: RECIPE Chemicals + Instruments GmbH
Manufacturer SRN: DE-MF-000032553
UDI-DI: D-15500FM
Basic UDI-DI: B-15500FM
Reference: 15500
EMDN: W0102080215
EMDN description: LEVETIRACETAM
First on market country: Germany
Authorised representative: -
Last updated: 11.07.2026 08:47

Manufacturer products View details