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EUDAMED Device Search

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

Last updated

01.08.2026 18:27

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178 device results listed.

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PCT Control

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

Manufacturer: SHENZHEN EVER-BLUE BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000025048
UDI-DI: 06973880812992
Basic UDI-DI: 697388081002NL
Reference: ZCC036
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 30.06.2026 12:09

Manufacturer products Authorised representative products Authorised representative actors View details

hs-cTnT Control

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IVD Class CNot specifiedOn the market

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053079709
Basic UDI-DI: 69449040AB74000555V
Reference: 105-046729-00
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 29.06.2026 14:11

Manufacturer products Authorised representative products Authorised representative actors View details

High Sensitivity Cardiac Troponin T （CLIA）

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IVD Class CNot specifiedOn the market

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053079716
Basic UDI-DI: 69449040AB74000555V
Reference: 105-046725-00
EMDN: W0102152004
EMDN description: TROPONIN I/T
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 29.06.2026 14:11

Manufacturer products Authorised representative products Authorised representative actors View details

hs-cTnT Calibrators

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IVD Class CNot specifiedOn the market

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053079747
Basic UDI-DI: 69449040AB74000555V
Reference: 105-046727-00
EMDN: W0102152004
EMDN description: CARDIAC MARKER STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 29.06.2026 14:11

Manufacturer products Authorised representative products Authorised representative actors View details

High Sensitivity Cardiac Troponin T （CLIA）

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IVD Class CNot specifiedOn the market

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053079754
Basic UDI-DI: 69449040AB74000555V
Reference: 105-046726-00
EMDN: W0102152004
EMDN description: TROPONIN I/T
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 29.06.2026 14:11

Manufacturer products Authorised representative products Authorised representative actors View details

hs-cTnT Control

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IVD Class CNot specifiedOn the market

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053079785
Basic UDI-DI: 69449040AB74000555V
Reference: 105-046732-00
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 29.06.2026 14:11

Manufacturer products Authorised representative products Authorised representative actors View details

hs-cTnT Control

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IVD Class CNot specifiedOn the market

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053079792
Basic UDI-DI: 69449040AB74000555V
Reference: 105-046730-00
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 29.06.2026 14:11

Manufacturer products Authorised representative products Authorised representative actors View details

hs-cTnT Control

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IVD Class CNot specifiedOn the market

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053079808
Basic UDI-DI: 69449040AB74000555V
Reference: 105-046728-00
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 29.06.2026 14:11

Manufacturer products Authorised representative products Authorised representative actors View details

hs-cTnT Control

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IVD Class CNot specifiedOn the market

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053079815
Basic UDI-DI: 69449040AB74000555V
Reference: 105-046731-00
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 29.06.2026 14:11

Manufacturer products Authorised representative products Authorised representative actors View details

N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) Quality Control

N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) Quality Control

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334808756
Basic UDI-DI: B-06950334808756
Reference: 52108036
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Bulgaria
Authorised representative: Medunion S.L.
Last updated: 28.06.2026 07:41

Manufacturer products Authorised representative products Authorised representative actors View details

Cardiac Troponin I (cTnI) Quality Control

Cardiac Troponin I (cTnI) Quality Control

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334808732
Basic UDI-DI: B-06950334808732
Reference: 52105055
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Bulgaria
Authorised representative: Medunion S.L.
Last updated: 28.06.2026 07:41

Manufacturer products Authorised representative products Authorised representative actors View details

CK-MB (CK-MB) Quality Control

CK-MB (CK-MB) Quality Control

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334808718
Basic UDI-DI: B-06950334808718
Reference: 52105061
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Bulgaria
Authorised representative: Medunion S.L.
Last updated: 28.06.2026 07:40

Manufacturer products Authorised representative products Authorised representative actors View details

Cardiac Markers Control

AutoLumo analyzer

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359507585
Basic UDI-DI: 697015090000354HN
Reference: ZKD0307
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 26.06.2026 19:48

Manufacturer products Authorised representative products Authorised representative actors View details

Cardiac Markers Control

AutoLumo analyzer

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359507547
Basic UDI-DI: 697015090000354HN
Reference: ZKD0207
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 26.06.2026 19:48

Manufacturer products Authorised representative products Authorised representative actors View details

Cardiac Markers Control

AutoLumo analyzer

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359507509
Basic UDI-DI: 697015090000354HN
Reference: ZKD0107
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 26.06.2026 19:48

Manufacturer products Authorised representative products Authorised representative actors View details

Myocardial Markers Control

1 mL×2 (2 levels, lyophilized product)

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000019511
UDI-DI: 06942293591633
Basic UDI-DI: 697518250P119036V
Reference: P11903
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 26.06.2026 19:31

Manufacturer products Authorised representative products Authorised representative actors View details

High Sensitive Cardiac Troponin I Control Solution (FIA)

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IVD generalNot specifiedOn the market

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06937339210630
Basic UDI-DI: B-06937339210630
Reference: VIC113-03-011
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 22:58

Manufacturer products Authorised representative products Authorised representative actors View details

Cardiac Troponin T Control Solution (FIA)

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IVD generalNot specifiedOn the market

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06937339210623
Basic UDI-DI: B-06937339210623
Reference: VIC60-03-011
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 22:58

Manufacturer products Authorised representative products Authorised representative actors View details

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

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IVD generalNot specifiedOn the market

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06937339210616
Basic UDI-DI: B-06937339210616
Reference: VIC45-03-011
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 22:58

Manufacturer products Authorised representative products Authorised representative actors View details

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

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IVD generalNot specifiedOn the market

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06937339210609
Basic UDI-DI: B-06937339210609
Reference: VIC15-03-011
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 22:58

Manufacturer products Authorised representative products Authorised representative actors View details