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178 device results listed.

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hs-cTnT Control

105-046725-00, 105-046726-00, 105-046727-00, 105-046728-00, 105-046731-00, 105-046732-00, 105-046729-00, 105-046730-00, 105-046733-00

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053079693
Basic UDI-DI: 69449040AB74000555V
Reference: 105-046733-00
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:51

Manufacturer products Authorised representative products Authorised representative actors View details

hs-cTnI Control

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

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912738787
Basic UDI-DI: 692591270345HN
Reference: CC456
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:38

Manufacturer products Authorised representative products Authorised representative actors View details

BNP Control

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

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912738268
Basic UDI-DI: 692591270315HD
Reference: CC372
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:37

Manufacturer products Authorised representative products Authorised representative actors View details

NT-proBNP Control

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

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912737889
Basic UDI-DI: 692591270343HJ
Reference: CC453
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:37

Manufacturer products Authorised representative products Authorised representative actors View details

CARDIAC CONTROL - ULTRA LOW (CRD CONTROL Ultra Low)

CARDIAC CONTROL

IVD Class BIVDR 2017/746On the marketNo EU repAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273217117
Basic UDI-DI: 50552732BCRDCON001AS
Reference: CQ10453
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:13

Manufacturer products View details

B·R·A·H·M·S Copeptin proAVP KRYPTOR QC

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: B·R·A·H·M·S GmbH
Manufacturer SRN: DE-MF-000026030
UDI-DI: 04260157632318
Basic UDI-DI: 426015763857BCoAVPKQCXXG9
Reference: 085792N
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:34

Manufacturer products View details

B·R·A·H·M·S CYFRA 21-1 KRYPTOR

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

Manufacturer: B·R·A·H·M·S GmbH
Manufacturer SRN: DE-MF-000026030
UDI-DI: 04260157631915
Basic UDI-DI: 426015763811BCYFRA21KXX4U
Reference: 811050N
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:34

Manufacturer products View details

ADVIA Centaur BNP Calibrator (BNP Cal)

IVDR_67_TTN_DUB-C_C_REAG_BNP_Cal

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414472836
Basic UDI-DI: 0405686900812VJ
Reference: 10309047
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
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 BNP 1,2,3 Quality Control

IVDR_67_TTN_DUB-C_C_REAG_BNP_QC

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414472829
Basic UDI-DI: 0405686900813VL
Reference: 10309046
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
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

D-6177K

Cardiac Markers Plus Control

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shanghai Kehua Bio-engineering Co., Ltd.
Manufacturer SRN: CN-MF-000026756
UDI-DI: D-6177K
Basic UDI-DI: B-6177K
Reference: /
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 17.07.2026 03:18

Manufacturer products Authorised representative products Authorised representative actors View details

Multi Control Cardiac Marker II

Level 1, Level 2, Level 3: 2 x 2.0 mL； Level 1, Level 2, Level 3: 4 x 2.0 mL； Level 1: 3 x 2.0 mL； Level 2: 3 x 2.0 mL； Level 3: 3 x 2.0 mL； Level 1: 6 x 2.0 mL； Level 2: 6 x 2.0 mL； Level 3: 6 x 2.0 mL

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06978139073247
Basic UDI-DI: 6970341680320501501LF
Reference: 0320514404
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.07.2026 11:04

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur NT-proBNP (PBNP) Master Curve Material (MCM)

IVDR_67_TTN_DUB-C_C_REAG_PBNP MCM

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414602899
Basic UDI-DI: 0405686901861W6
Reference: 10994359
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:36

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE NT-pro-BNP Control Module

IVDR_67_LLB_DUB-C_C_REAG_NT-pro-BNP Control Module

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414953243
Basic UDI-DI: 0405686901482VS
Reference: 10385339
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:24

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM B-type Natriuretic Peptide Quality Control (BNP QC)

IVDR_67_TTN_DUB-C_C_REAG_BNP_QC

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414598024
Basic UDI-DI: 0405686900813VL
Reference: 10995475
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
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 IM High-Sensitivity Troponin I Master Curve Material (TnIH MCM)

IVDR_67_TTN_DUB-C_C_REAG_TnIH_MCM

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414006772
Basic UDI-DI: 0405686900834VU
Reference: 10997842
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
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

VivaDiag Cardiac Troponin T Control Solution (FIA)

VIC60

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VIC602U
Basic UDI-DI: B-VIC602U
Reference: VIC60-03-011
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:19

Manufacturer products Authorised representative products Authorised representative actors View details

Cardiac Combo (cTnI/CK-MB) Control Solution (FIA)

VIC45

IVD generalIVDDOn the marketAnimal tissuesProfessional testing

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VIC452Y
Basic UDI-DI: B-VIC452Y
Reference: VIC45-03-011
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:19

Manufacturer products Authorised representative products Authorised representative actors View details

Cardiac Combo (cTnI/CK-MB/MYO) Control Solution (FIA)

VIC15

IVD generalIVDDOn the marketAnimal tissuesProfessional testing

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VIC152P
Basic UDI-DI: B-VIC152P
Reference: VIC15-03-011
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:18

Manufacturer products Authorised representative products Authorised representative actors View details

VivaDiag N-terminal Pro-brain Natriuretic Peptide Control Solution (FIA)

VIC14

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VIC142M
Basic UDI-DI: B-VIC142M
Reference: VIC14-03-011
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:17

Manufacturer products Authorised representative products Authorised representative actors View details

VivaDiag Heart Fatty Acid Binding Protein Control Solution (FIA)

VIC13

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VIC132K
Basic UDI-DI: B-VIC132K
Reference: VIC13-03-011
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:17

Manufacturer products Authorised representative products Authorised representative actors View details