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hs-cTnT Assay Kit (ECLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Jiangsu Sunlant Bioengineering Co., Ltd.
Manufacturer SRN: CN-MF-000025940
UDI-DI: D-SEK013DF
Basic UDI-DI: B-SEK013DF
Reference: SE-K013
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 15.07.2026 06:12

Manufacturer products Authorised representative products Authorised representative actors View details

CKMB Assay Kit (ECLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Jiangsu Sunlant Bioengineering Co., Ltd.
Manufacturer SRN: CN-MF-000025940
UDI-DI: D-SEK012DD
Basic UDI-DI: B-SEK012DD
Reference: SE-K012
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 15.07.2026 06:12

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NT-proBNP Assay Kit (ECLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Jiangsu Sunlant Bioengineering Co., Ltd.
Manufacturer SRN: CN-MF-000025940
UDI-DI: D-SEK011DB
Basic UDI-DI: B-SEK011DB
Reference: SE-K011
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 15.07.2026 06:12

Manufacturer products Authorised representative products Authorised representative actors View details

D-R22214ZV

30 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R22214ZV
Basic UDI-DI: B-R22214ZV
Reference: R22214
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 15.07.2026 05:25

Manufacturer products Authorised representative products Authorised representative actors View details

D-R22213ZT

200 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R22213ZT
Basic UDI-DI: B-R22213ZT
Reference: R22213
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 15.07.2026 05:25

Manufacturer products Authorised representative products Authorised representative actors View details

D-R22212ZR

100 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R22212ZR
Basic UDI-DI: B-R22212ZR
Reference: R22212
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 15.07.2026 05:25

Manufacturer products Authorised representative products Authorised representative actors View details

D-R22211ZP

50 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R22211ZP
Basic UDI-DI: B-R22211ZP
Reference: R22211
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 15.07.2026 05:25

Manufacturer products Authorised representative products Authorised representative actors View details

OMOCISTEINA LR

FCC243-2

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: FUTURLAB S.R.L.
Manufacturer SRN: IT-MF-000046539
UDI-DI: D-OMOCISTEINA-LRWD
Basic UDI-DI: B-OMOCISTEINA-LRWD
Reference: FCC243-2
EMDN: W01021307
EMDN description: HOMOCYSTEINE
First on market country: Italy
Authorised representative: -
Last updated: 14.07.2026 06:14

Manufacturer products View details

NT-proBNP N-Terminal Pro-Brain Natriuretic Peptide (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-NT-proBNP706-AE3K
Basic UDI-DI: B-NT-proBNP706-AE3K
Reference: NT-proBNP706-AE10Y, NT-proBNP706-AE10N, NT-proBNP706-AE20Y, NT-proBNP706-AE20N
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 06:07

Manufacturer products Authorised representative products Authorised representative actors View details

MYO Myoglobin (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-MYO706-AED7
Basic UDI-DI: B-MYO706-AED7
Reference: MYO706-AE10Y, MYO706-AE10N, MYO706-AE20Y, MYO706-AE20N
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 05:18

Manufacturer products Authorised representative products Authorised representative actors View details

ClinSpot®

MS2100

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: RECIPE Chemicals + Instruments GmbH
Manufacturer SRN: DE-MF-000032553
UDI-DI: D-MS2100AF
Basic UDI-DI: B-MS2100AF
Reference: MS2100
EMDN: W01021307
EMDN description: HOMOCYSTEINE
First on market country: Germany
Authorised representative: -
Last updated: 14.07.2026 05:14

Manufacturer products View details

ClinMass®

MS2000

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: RECIPE Chemicals + Instruments GmbH
Manufacturer SRN: DE-MF-000032553
UDI-DI: D-MS2000AA
Basic UDI-DI: B-MS2000AA
Reference: MS2000
EMDN: W01021307
EMDN description: HOMOCYSTEINE
First on market country: Germany
Authorised representative: -
Last updated: 14.07.2026 05:14

Manufacturer products View details

BGI

96 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: D-MFG030065R2
Basic UDI-DI: B-MFG030065R2
Reference: MFG030065
EMDN: W01021399
EMDN description: CARDIAC MARKERS - OTHER
First on market country: Denmark
Authorised representative: -
Last updated: 14.07.2026 05:06

Manufacturer products View details

Myoglobin Reagent Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-MB601TR
Basic UDI-DI: B-MB601TR
Reference: MB6011Y, MB6012Y, MB6013Y, MB6014Y, MB6015Y, MB6011N, MB6012N, MB6013N, MB6014N, MB6015N
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 04:53

Manufacturer products Authorised representative products Authorised representative actors View details

INNODX Hs-cTnT STAT CMIA

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Xiamen Innodx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000041071
UDI-DI: D-KR-cTnT-03100VE
Basic UDI-DI: B-KR-cTnT-03100VE
Reference: KR-cTnT-03100
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 03:47

Manufacturer products Authorised representative products Authorised representative actors View details

INNODX ST2 STAT CMIA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Innodx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000041071
UDI-DI: D-KR-ST2STAT-05100XH
Basic UDI-DI: B-KR-ST2STAT-05100XH
Reference: KR-ST2 STAT-05100
EMDN: W01021314
EMDN description: ST2
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 03:45

Manufacturer products Authorised representative products Authorised representative actors View details

INNODX ST2 STAT CMIA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Innodx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000041071
UDI-DI: D-KR-ST2STAT-02505Q
Basic UDI-DI: B-KR-ST2STAT-02505Q
Reference: KR-ST2 STAT-0250
EMDN: W01021314
EMDN description: ST2
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 03:45

Manufacturer products Authorised representative products Authorised representative actors View details

INNODX ST2 STAT CMIA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Innodx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000041071
UDI-DI: D-KR-ST2STAT-02200WZ
Basic UDI-DI: B-KR-ST2STAT-02200WZ
Reference: KR-ST2 STAT-02200
EMDN: W01021314
EMDN description: ST2
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 03:45

Manufacturer products Authorised representative products Authorised representative actors View details

INNODX ST2 STAT CMIA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Innodx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000041071
UDI-DI: D-KR-ST2STAT-01100WM
Basic UDI-DI: B-KR-ST2STAT-01100WM
Reference: KR-ST2 STAT-01100
EMDN: W01021314
EMDN description: ST2
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 03:45

Manufacturer products Authorised representative products Authorised representative actors View details

INNODX Myo STAT CMIA

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Xiamen Innodx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000041071
UDI-DI: D-KR-MyoSTAT-0250FT
Basic UDI-DI: B-KR-MyoSTAT-0250FT
Reference: KR-Myo STAT-0250
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 03:45

Manufacturer products Authorised representative products Authorised representative actors View details