Public EUDAMED Search

EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

TR EN

Last updated

01.08.2026 18:27

Sync status

Successful

Device

2989865

Actor

47523

Certificate

3174

Filters

Show filters

Active filter:EMDN:W010213

1000+ device results listed.

Page 7 / 50

CSV XML

D-6-50A9

Myoglobin (MYO) Assay Kit (Latex Immunoturbidimetric Method)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-6-50A9
Basic UDI-DI: B-6-50A9
Reference: "REF: USCA00000700, USCA00000701, USCA00000702, USCA00000703, USCA00000704, U86581045M"
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:13

Manufacturer products Authorised representative products Authorised representative actors View details

D-6-16T

Homocysteine（HCY）Reagent Kit (Enzymatic Cycling Method)

IVD generalIVDDOn the marketMicrobial substancesProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-6-16T
Basic UDI-DI: B-6-16T
Reference: "REF: U83582015M, U83582030M, U83589045M, U83585015M, U83511020M, U83520030M"
EMDN: W01021307
EMDN description: HOMOCYSTEINE
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:09

Manufacturer products Authorised representative products Authorised representative actors View details

D-6-133FF

Cardiac troponin I (cTnI ) Test Kit (Latex Immunoturbidimetric Method)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-6-133FF
Basic UDI-DI: B-6-133FF
Reference: "REF: USCA00000740, USCA00000743 USCA00000741, USCA00000742 USCA00000744, USCA00000781"
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:08

Manufacturer products Authorised representative products Authorised representative actors View details

06954418517374

25 Tests /kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Shanghai Medconn Biotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000038615
UDI-DI: 06954418517374
Basic UDI-DI: B-06954418517374
Reference: NA
EMDN: W01021399
EMDN description: CARDIAC MARKERS - OTHER
First on market country: Spain
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 16.07.2026 18:57

Manufacturer products Authorised representative products Authorised representative actors View details

hs-cTnI Reagent kit

50 Tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shanghai Medconn Biotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000038615
UDI-DI: 06954418517381
Basic UDI-DI: B-06954418517381
Reference: /
EMDN: W01021399
EMDN description: CARDIAC MARKERS - OTHER
First on market country: Spain
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 16.07.2026 18:57

Manufacturer products Authorised representative products Authorised representative actors View details

AFIAS BNP

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133043400
Basic UDI-DI: 880613300572CM
Reference: SMFP-83
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Netherlands
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:43

Manufacturer products Authorised representative products Authorised representative actors View details

AFIAS hsCRP

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

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133043226
Basic UDI-DI: 880613300617CJ
Reference: SMFP-78
EMDN: W01021308
EMDN description: HIGH-SENSITIVITY C-.REACTIVE PROTEIN
First on market country: Austria
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:43

Manufacturer products Authorised representative products Authorised representative actors View details

AFIAS NT-proBNP/ST2

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133042830
Basic UDI-DI: 880613300626CK
Reference: SMFP-85
EMDN: W01021399
EMDN description: CARDIAC MARKERS - OTHER
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:43

Manufacturer products Authorised representative products Authorised representative actors View details

ichroma™ NT-proBNP/ST2

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133042793
Basic UDI-DI: 880613300029BT
Reference: CFPC-163
EMDN: W01021399
EMDN description: CARDIAC MARKERS - OTHER
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:43

Manufacturer products Authorised representative products Authorised representative actors View details

AFIAS CK-MB Neo

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133042380
Basic UDI-DI: 880613300608CH
Reference: SMFP-128
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:43

Manufacturer products Authorised representative products Authorised representative actors View details

hs-cTnI STAT (eCLIA)

50T, 2×50T, 100T, 2×100T

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06978139071724
Basic UDI-DI: 69703416803205080JK
Reference: 0320513401
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.07.2026 11:03

Manufacturer products Authorised representative products Authorised representative actors View details

BNP (eCLIA)

50T, 2×50T, 100T, 2×100T

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984064277
Basic UDI-DI: 69703416803205089K5
Reference: 0320511101
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.07.2026 11:03

Manufacturer products Authorised representative products Authorised representative actors View details

H-FABP STAT (eCLIA)

50T, 2×50T, 100T, 2×100T

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984064130
Basic UDI-DI: 69703416803205090JN
Reference: 0320511201
EMDN: W01021302
EMDN description: HEART-TYPE FATTY ACID BINDING PROTEIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.07.2026 11:03

Manufacturer products Authorised representative products Authorised representative actors View details

HS-CRP STAT (eCLIA)

50T, 2×50T, 100T, 2×100T

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984063898
Basic UDI-DI: 69703416803205095JY
Reference: 0320511401
EMDN: W01021308
EMDN description: HIGH-SENSITIVITY C-.REACTIVE PROTEIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.07.2026 11:03

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays Myeloperoxidase (Latex Immunoturbidimetric)

Myeloperoxidase (Latex Immunoturbidimetric)

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145589134
Basic UDI-DI: 69471455643WP
Reference: 130504013S
EMDN: W01021310
EMDN description: MYELOPEROXIDASE
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.07.2026 10:43

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays High Sensitivity C-Reactive Protein (Latex Immunoturbidimetric)

High Sensitivity C-Reactive Protein (Latex Immunoturbidimetric)

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145557201
Basic UDI-DI: 69471455635WQ
Reference: 130504012S
EMDN: W01021308
EMDN description: HIGH-SENSITIVITY C-.REACTIVE PROTEIN
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.07.2026 10:42

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays Myoglobin (Latex Immunoturbidimetric)

Myoglobin (Latex Immunoturbidimetric)

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145555689
Basic UDI-DI: 69471455606WH
Reference: 130504010A
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.07.2026 10:42

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays Heart-type Fatty Acid-Binding Protein (Latex Immunoturbidimetric)

Heart-type Fatty Acid-Binding Protein (Latex Immunoturbidimetric)

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145551568
Basic UDI-DI: 69471455625WM
Reference: 130504011S
EMDN: W01021302
EMDN description: HEART-TYPE FATTY ACID BINDING PROTEIN
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.07.2026 10:42

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI sST2 (CLIA)

sST2 (CLIA)

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

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145541552
Basic UDI-DI: 69471455186WG
Reference: 130606022M
EMDN: W01021314
EMDN description: ST2
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.07.2026 10:42

Manufacturer products Authorised representative products Authorised representative actors View details

PATHFAST NTproBNP

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: PHC Corporation
Manufacturer SRN: JP-MF-000008516
UDI-DI: 04987595301612
Basic UDI-DI: 4987595PF1061KXK
Reference: 30161
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Netherlands
Safety summary (SSCP/SSP): YM-R14-7006 · Rev. 6
Authorised representative: PHC Europe B.V.
Last updated: 16.07.2026 09:40

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details