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14 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

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 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

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

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

RapidFor™ Carbamazepine Rapid Test Kit (FIA)

VMPO16

IVD generalIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548250278
Basic UDI-DI: B-08683548250278
Reference: VMPO16
EMDN: W0102080201
EMDN description: CARBAMAZEPINE
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 00:09

Manufacturer products View details

00884883008120

08P5820

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Microgenics Corporation
Manufacturer SRN: US-MF-000030375
UDI-DI: 00884883008120
Basic UDI-DI: B-00884883008120
Reference: 08P5820
EMDN: W0102080201
EMDN description: CARBAMAZEPINE
First on market country: Germany
Authorised representative: B·R·A·H·M·S GmbH
Last updated: 05.07.2026 12:25

Manufacturer products Authorised representative products Authorised representative actors View details

00884883007970

05P05-21

IVD generalIVDDOn the marketAnimal tissuesKitReagent

Manufacturer: Microgenics Corporation
Manufacturer SRN: US-MF-000030375
UDI-DI: 00884883007970
Basic UDI-DI: B-00884883007970
Reference: 05P05-21
EMDN: W0102080201
EMDN description: CARBAMAZEPINE
First on market country: Germany
Authorised representative: B·R·A·H·M·S GmbH
Last updated: 05.07.2026 12:25

Manufacturer products Authorised representative products Authorised representative actors View details

00884883001251

100006

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Microgenics Corporation
Manufacturer SRN: US-MF-000030375
UDI-DI: 00884883001251
Basic UDI-DI: B-00884883001251
Reference: 100006
EMDN: W0102080201
EMDN description: CARBAMAZEPINE
First on market country: Germany
Authorised representative: B·R·A·H·M·S GmbH
Last updated: 05.07.2026 12:12

Manufacturer products Authorised representative products Authorised representative actors View details

00380740102685

5P05-21

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Microgenics Corporation
Manufacturer SRN: US-MF-000030375
UDI-DI: 00380740102685
Basic UDI-DI: B-00380740102685
Reference: 5P05-21
EMDN: W0102080201
EMDN description: CARBAMAZEPINE
First on market country: Germany
Authorised representative: Thermo Fisher Scientific Oy
Last updated: 04.07.2026 16:46

Manufacturer products Authorised representative products Authorised representative actors View details

Carbamazepine CLIA Kit (Chemiluminescence Immunoassay)

100 tests/box

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000019511
UDI-DI: 06942293590551
Basic UDI-DI: 697518250F1140424
Reference: F11404
EMDN: W0102080201
EMDN description: CARBAMAZEPINE
First on market country: Italy
Authorised representative: MedNet EC-REP GmbH
Last updated: 26.06.2026 19:29

Manufacturer products Authorised representative products Authorised representative actors View details

Carbamazepine Determination Kit (Fluorescence Immunochromatographic Assay)

25 tests

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle useSterile

Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000019511
UDI-DI: 06942293580170
Basic UDI-DI: 697518250P114066A
Reference: P11406
EMDN: W0102080201
EMDN description: CARBAMAZEPINE
First on market country: Italy
Authorised representative: MedNet EC-REP GmbH
Last updated: 26.06.2026 19:22

Manufacturer products Authorised representative products Authorised representative actors View details