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ADVIA Centaur® BNP

IVDR_67_TTN_DUB-C_C_KIT_BNP

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414472805
Basic UDI-DI: 0405686900805VM
Reference: 10309044
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
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

ADVIA Centaur Myoglobin

IVDR_67_TTN_DUB-C_C_REAG_MYO

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414197197
Basic UDI-DI: 0405686900829W3
Reference: 10329242
EMDN: W01021304
EMDN description: MYOGLOBIN
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

Atellica IM High‑Sensitivity Troponin I (TnIH)

IVDR_67_TTN_DUB-C_C_KIT_TnIH

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414006703
Basic UDI-DI: 0405686900809VV
Reference: 10997840
EMDN: W01021306
EMDN description: TROPONIN I/T
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 EXL LOCI High Sensitivity Troponin I Flex Reagent Cartridge

IVDR_67_GLA_DUB-C_C_REAG_TNIH

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768037726
Basic UDI-DI: 0405686900216UU
Reference: 10471068
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:07

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CardioPhase hsCRP

IVDR_27_MAR EB_C_PROF_REAG_Card_hsCRP

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

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768007729
Basic UDI-DI: 0405686900141UN
Reference: 10446090
EMDN: W01021308
EMDN description: HIGH-SENSITIVITY C-.REACTIVE PROTEIN
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:07

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Atellica IM B-type Natriuretic Peptide (BNP)

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414597980
Basic UDI-DI: 0405686900805VM
Reference: 10995471
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 15.07.2026 22:49

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Atellica IM B-type Natriuretic Peptide (BNP)

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414597997
Basic UDI-DI: 0405686900805VM
Reference: 10995472
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 15.07.2026 22:49

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Atellica IM Creatine Kinase MB (CKMB)

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414598574
Basic UDI-DI: 0405686901804VS
Reference: 10995530
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 15.07.2026 22:49

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Atellica IM Creatine Kinase MB (CKMB)

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414598581
Basic UDI-DI: 0405686901804VS
Reference: 10995531
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 15.07.2026 22:49

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur NT‑proBNPII (PBNPII)

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414284934
Basic UDI-DI: 0405686902296W2
Reference: 11203760
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 15.07.2026 22:49

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Atellica IM NT‑proBNPII (PBNPII)

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414284958
Basic UDI-DI: 0405686902296W2
Reference: 11203762
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 15.07.2026 22:49

Manufacturer products Authorised representative products Authorised representative actors View details

cTn-T Cardiac Troponin T (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-hs-cTnT706-AE3N
Basic UDI-DI: B-hs-cTnT706-AE3N
Reference: hs-cTnT706-AE10Y, hs-cTnT706-AE10N, hs-cTnT706-AE20Y, hs-cTnT706-AE20N
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 14:19

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cTn-I Cardiac Troponin I (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-hs-cTnI706-AEVQ
Basic UDI-DI: B-hs-cTnI706-AEVQ
Reference: hs-cTnI706-AE10Y, hs-cTnI706-AE10N, hs-cTnI706-AE20Y, hs-cTnI706-AE20N
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 14:19

Manufacturer products Authorised representative products Authorised representative actors View details

hs-cTnI/CK-MB (CLIA)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: DROPHIL BIOTECH (SHENZHEN) COMPANY LIMITED
Manufacturer SRN: CN-MF-000042193
UDI-DI: D-hs-cTnI/CK-MB63
Basic UDI-DI: B-hs-cTnI/CK-MB63
Reference: 48 tests/kit:(Excluding calibrators and controls)/(Including calibrators)/(Including calibrators and controls)
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 15.07.2026 14:19

Manufacturer products Authorised representative products Authorised representative actors View details

Cardiac Troponin I Reagent Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-cTnI601RE
Basic UDI-DI: B-cTnI601RE
Reference: cTnI6011Y, cTnI6012Y, cTnI6013Y, cTnI6014Y, cTnI6015Y, cTnI6011N, cTnI6012N, cTnI6013N, cTnI6014N, cTnI6015N
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 14:19

Manufacturer products Authorised representative products Authorised representative actors View details

Homocysteine Test Kit (FIA)

VID34

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID342Y
Basic UDI-DI: B-VID342Y
Reference: VID34-03-011
EMDN: W01021307
EMDN description: HOMOCYSTEINE
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:22

Manufacturer products Authorised representative products Authorised representative actors View details

VivaDiag High Sensitive Cardiac Troponin I Test Kit (FIA)

VID113

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID113EN
Basic UDI-DI: B-VID113EN
Reference: VID113-03-011
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:20

Manufacturer products Authorised representative products Authorised representative actors View details

D-TD-HNKX-CED-654H

Myoglobin Kit (Microfluidic Fluorescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hunan Kangxin Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000020121
UDI-DI: D-TD-HNKX-CED-654H
Basic UDI-DI: B-TD-HNKX-CED-654H
Reference: /
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 10:57

Manufacturer products Authorised representative products Authorised representative actors View details

D-TD-HNKX-CED-644F

Creatine Kinase Myocardial Isoenzyme Kit (Microfluidic Fluorescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hunan Kangxin Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000020121
UDI-DI: D-TD-HNKX-CED-644F
Basic UDI-DI: B-TD-HNKX-CED-644F
Reference: /
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 10:57

Manufacturer products Authorised representative products Authorised representative actors View details

D-TD-HNKX-CED-6047

Homocysteine Kit (Microfluidic Fluorescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Hunan Kangxin Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000020121
UDI-DI: D-TD-HNKX-CED-6047
Basic UDI-DI: B-TD-HNKX-CED-6047
Reference: /
EMDN: W01021307
EMDN description: HOMOCYSTEINE
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 10:57

Manufacturer products Authorised representative products Authorised representative actors View details