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D-TD-HNKX-CED-2545

B-type Natriuretic Protein Kit (Microfluidic Fluorescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hunan Kangxin Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000020121
UDI-DI: D-TD-HNKX-CED-2545
Basic UDI-DI: B-TD-HNKX-CED-2545
Reference: /
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 10:56

Manufacturer products Authorised representative products Authorised representative actors View details

D-TD-HNKX-CED-2749

DISKFLU Multiple Cardiac Marker Kit (Microfluidic Fluorescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hunan Kangxin Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000020121
UDI-DI: D-TD-HNKX-CED-2749
Basic UDI-DI: B-TD-HNKX-CED-2749
Reference: /
EMDN: W01021399
EMDN description: CARDIAC MARKERS - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 10:56

Manufacturer products Authorised representative products Authorised representative actors View details

D-TD-HNKX-CED-233Z

LYOFIA Multiple Cardiac Marker Kit (Microfluidic Fluorescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hunan Kangxin Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000020121
UDI-DI: D-TD-HNKX-CED-233Z
Basic UDI-DI: B-TD-HNKX-CED-233Z
Reference: /
EMDN: W01021399
EMDN description: CARDIAC MARKERS - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 10:56

Manufacturer products Authorised representative products Authorised representative actors View details

D-TD-HNKX-CED-223X

High Sensitive Cardiac Troponin I Kit (Microfluidic Fluorescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hunan Kangxin Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000020121
UDI-DI: D-TD-HNKX-CED-223X
Basic UDI-DI: B-TD-HNKX-CED-223X
Reference: /
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 10:56

Manufacturer products Authorised representative products Authorised representative actors View details

ST2 Growth Stimulation Expressed gene 2 (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-ST2706-AEXK
Basic UDI-DI: B-ST2706-AEXK
Reference: ST2706-AE10Y, ST2706-AE10N, ST2706-AE20Y, ST2706-AE20N
EMDN: W01021314
EMDN description: ST2
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 10:44

Manufacturer products Authorised representative products Authorised representative actors View details

BNP Assay Kit (ECLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Jiangsu Sunlant Bioengineering Co., Ltd.
Manufacturer SRN: CN-MF-000025940
UDI-DI: D-SEK021DE
Basic UDI-DI: B-SEK021DE
Reference: SE-K021
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 15.07.2026 06:13

Manufacturer products Authorised representative products Authorised representative actors View details

hs-cTnI Assay Kit (ECLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Jiangsu Sunlant Bioengineering Co., Ltd.
Manufacturer SRN: CN-MF-000025940
UDI-DI: D-SEK014DH
Basic UDI-DI: B-SEK014DH
Reference: SE-K014
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

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

Manufacturer products Authorised representative products Authorised representative actors View details

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