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56 device results listed.

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Digoxin Detection Kit (Chemiluminescence Immunoassay)

1×100 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794521101
Basic UDI-DI: B-06925794521101
Reference: 3013997
EMDN: W0102080101
EMDN description: DIGOXIN
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:36

Manufacturer products Authorised representative products Authorised representative actors View details

Digoxin Detection Kit (Chemiluminescence Immunoassay)

1×50 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794521095
Basic UDI-DI: B-06925794521095
Reference: 3014022
EMDN: W0102080101
EMDN description: DIGOXIN
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:36

Manufacturer products Authorised representative products Authorised representative actors View details

Digoxin

OSR6404

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Beckman Coulter Ireland Inc.
Manufacturer SRN: IE-MF-000000887
UDI-DI: 15099590040031
Basic UDI-DI: 150995902OSR6404MV
Reference: OSR6404
EMDN: W0102080101
EMDN description: DIGOXIN
First on market country: Ireland
Authorised representative: -
Last updated: 30.07.2026 20:30

Manufacturer products View details

Digitoxin

OSR6403

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Beckman Coulter Ireland Inc.
Manufacturer SRN: IE-MF-000000887
UDI-DI: 15099590040024
Basic UDI-DI: 150995902OSR6403MT
Reference: OSR6403
EMDN: W0102080102
EMDN description: DIGITOXIN
First on market country: Ireland
Authorised representative: -
Last updated: 30.07.2026 20:30

Manufacturer products View details

Atellica IM Digoxin (Dig)

IVDR_67_TTN_DUB-C_C_REAG_Digoxin

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414598819
Basic UDI-DI: 0405686901848WE
Reference: 10995557
EMDN: W0102080101
EMDN description: DIGOXIN
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 20.07.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur Digoxin

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414177410
Basic UDI-DI: 0405686901808W2
Reference: 10309981
EMDN: W0102080101
EMDN description: DIGOXIN
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 20.07.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Digitoxin Flex reagent cartridge

IVDR_67_GLA_DUB-C_C_REAG_DGTX

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768005510
Basic UDI-DI: 0405686901252V7
Reference: 10444932
EMDN: W0102080102
EMDN description: DIGITOXIN
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:42

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE 2000 Digitoxin

IVDR_67_LLB_DUB-C_C_KIT_Dgtn

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

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414961262
Basic UDI-DI: 0405686901447VQ
Reference: 10381538
EMDN: W0102080102
EMDN description: DIGITOXIN
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 Digoxin

IVDR_67_LLB_DUB-C_C_REAG_KIT_Dgxn

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

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414961286
Basic UDI-DI: 0405686901448VS
Reference: 10381529
EMDN: W0102080101
EMDN description: DIGOXIN
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

Atellica IM Digoxin (Dig)

IVDR_67_TTN_DUB-C_C_REAG_Digoxin

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414598826
Basic UDI-DI: 0405686901848WE
Reference: 10995558
EMDN: W0102080101
EMDN description: DIGOXIN
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

ADVIA Centaur Digoxin

IVDR_67_TTN_DUB-C_C_KIT_DIG

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414177427
Basic UDI-DI: 0405686901808W2
Reference: 10322129
EMDN: W0102080101
EMDN description: DIGOXIN
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

Digoxin Reagent (DIGN 2 x 100)

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-650182PV
Basic UDI-DI: B-650182PV
Reference: 650182
EMDN: W0102080101
EMDN description: DIGOXIN
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 17.07.2026 03:43

Manufacturer products Authorised representative products Authorised representative actors View details

00884883008991

QMS Omecamtiv Mecarbil Immunoassay

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Microgenics Corporation
Manufacturer SRN: US-MF-000030375
UDI-DI: 00884883008991
Basic UDI-DI: 0884883QCDDFRREC15580D4
Reference: 10023163
EMDN: W0102080199
EMDN description: CARDIOVASCULAR TDM - OTHER
First on market country: Germany
Authorised representative: B·R·A·H·M·S GmbH
Last updated: 16.07.2026 07:23

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica CH Digoxin (Dgn)

IVDR_67_TTN_DUB-C_C_REAG_DGN

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414595863
Basic UDI-DI: 0405686901847WC
Reference: 11097526
EMDN: W0102080101
EMDN description: DIGOXIN
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 Procainamide (PROC)

IVDR_67_TTN_DUB-C_C_REAG_Procainamide

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414220673
Basic UDI-DI: 0405686901863WA
Reference: 11097538
EMDN: W0102080107
EMDN description: PROCAINAMIDE
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:33

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica CH N-Acetylprocainamide (NAPA)

IVDR_67_TTN_DUB-C_C_REAG_N-Acetylprocainamide

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414220659
Basic UDI-DI: 0405686901860W4
Reference: 11097537
EMDN: W0102080106
EMDN description: N-ACETYLPROCAINAMIDE
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:33

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: 00842768023255
Basic UDI-DI: 0405686901254VB
Reference: 10445317
EMDN: W0102080101
EMDN description: DIGOXIN
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:30

Manufacturer products Authorised representative products Authorised representative actors View details

Emit 2000 N-Acetylprocainamide Assay

IVDR_67_GLA_DUB-C_C_REAG_N-Acetylprocainamide Assay

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768017421
Basic UDI-DI: 0405686901287VS
Reference: 10445321
EMDN: W0102080106
EMDN description: N-ACETYLPROCAINAMIDE
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:30

Manufacturer products Authorised representative products Authorised representative actors View details

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 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