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 01:12

Sync status

Successful

Device

2988371

Actor

47517

Certificate

3174

Filters

Show filters

Active filter:EMDN:W01021306

347 device results listed.

Page 2 / 18

CSV XML

D-6-89B4

High-sensitive Cardiac Troponin T (hs-cTnT) Assay Kit (Chemiluminescent Microparticle Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-6-89B4
Basic UDI-DI: B-6-89B4
Reference: "REF: USIA00000081M, USIA00000082M"
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 03:14

Manufacturer products Authorised representative products Authorised representative actors View details

D-6-87AY

Cardiac Troponin I (cTnI) Assay Kit (Chemiluminescent Microparticle Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-6-87AY
Basic UDI-DI: B-6-87AY
Reference: "REF: USIA00000079M, USIA00000080M"
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 03:14

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

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

PATHFAST hs-cTnI

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

Manufacturer: PHC Corporation
Manufacturer SRN: JP-MF-000008516
UDI-DI: 04987595301179
Basic UDI-DI: 4987595PF1241KXP
Reference: 30117
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Netherlands
Safety summary (SSCP/SSP): YM-R14-7024 · 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

PATHFAST cTnI

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

Manufacturer: PHC Corporation
Manufacturer SRN: JP-MF-000008516
UDI-DI: 04987595301117
Basic UDI-DI: 4987595PF1011KWS
Reference: 30111
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Netherlands
Safety summary (SSCP/SSP): YM-R14-7001 · Rev. 5
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

IMMULITE 2000 Troponin I

IVDR_67_LLB_DUB-C_C_KIT_Troponin I

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

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414962122
Basic UDI-DI: 0405686901467VW
Reference: 10381034
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:26

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

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

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-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

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

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