Veriler yükleniyor…

Public EUDAMED Search

EUDAMED Device Search

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

Last updated

01.08.2026 13:11

Sync status

Successful

Device

2989310

Actor

47520

Certificate

3174

Filters

Show filters

Active filter:EMDN:W0102152004

178 device results listed.

Page 7 / 9

VALIDATE® CM1 Test Set

401db

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingSingle use

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000029697
UDI-DI: 00859110005616
Basic UDI-DI: B-00859110005616
Reference: 401db
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 05.07.2026 11:41

Manufacturer products Authorised representative products Authorised representative actors View details

VALIDATE® CM1 Test Set

401bc

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000029697
UDI-DI: 00859110005609
Basic UDI-DI: B-00859110005609
Reference: 401bc
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 05.07.2026 11:41

Manufacturer products Authorised representative products Authorised representative actors View details

VALIDATE® CM1 Test Set

401ab

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000029697
UDI-DI: 00859110005593
Basic UDI-DI: B-00859110005593
Reference: 401ab
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 05.07.2026 11:41

Manufacturer products Authorised representative products Authorised representative actors View details

VALIDATE® HS Troponin Test Set

405ab

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000029697
UDI-DI: 00850011135280
Basic UDI-DI: B-00850011135280
Reference: 405ab
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 05.07.2026 10:58

Manufacturer products Authorised representative products Authorised representative actors View details

VALIDATE® CM1 Test Set

401ro

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000029697
UDI-DI: 00850011135228
Basic UDI-DI: B-00850011135228
Reference: 401ro
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 05.07.2026 10:58

Manufacturer products Authorised representative products Authorised representative actors View details

VALIDATE® CM3 Test Set

409ro

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000029697
UDI-DI: 00850011135204
Basic UDI-DI: B-00850011135204
Reference: 409ro
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 05.07.2026 10:58

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI hs-CRP (CLIA) Controls

hs-CRP (CLIA) Controls

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145529482
Basic UDI-DI: 69471455494WW
Reference: 160201494MT
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:52

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI MPO (CLIA) Controls

MPO (CLIA) Controls

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145518233
Basic UDI-DI: 69471455187WJ
Reference: 160201187MT
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:51

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI H-FABP (CLIA) Controls

H-FABP (CLIA) Controls

IVD Class CIVDR 2017/746On the marketMicrobial substancesProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145515140
Basic UDI-DI: 69471455418WE
Reference: 160201418MT
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:51

Manufacturer products Authorised representative products Authorised representative actors View details

TROPONIN T CONTROL (TROPONIN T CONTROL)

-

IVD Class BNot specifiedOn the marketNo EU rep

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273216981
Basic UDI-DI: 50552732BLTTCON151TK
Reference: CQ10462
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Northern Ireland
Authorised representative: -
Last updated: 02.07.2026 01:42

Manufacturer products View details

98201

IVD Class CIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590750954
Basic UDI-DI: 150995901AccBNPQCFF
Reference: 98201
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:40

Manufacturer products Authorised representative products Authorised representative actors View details

Pylon Cardiac Control 2

Control-High Level:5x1mL Control-Low Level :5x1mL

IVD Class CIVDR 2017/746Not intended for EU marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: ET Healthcare (Suzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000039448
UDI-DI: 06976485023145
Basic UDI-DI: 697648502CC2SD
Reference: 08-0193 Control-High Level:5x1mL Control-Low Level :5x1mL
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: -
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 30.06.2026 12:20

Manufacturer products Authorised representative products Authorised representative actors View details

Pylon Cardiac Control 1

Control-High Level:5x1mL Control-Low Level :5x1mL

IVD Class CIVDR 2017/746Not intended for EU marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: ET Healthcare (Suzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000039448
UDI-DI: 06976485023138
Basic UDI-DI: 697648502CC1SB
Reference: 08-0183 Control-High Level:5x1mL Control-Low Level :5x1mL
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: -
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 30.06.2026 12:20

Manufacturer products Authorised representative products Authorised representative actors View details

Cardiac Markers Control

Analyzer (automatic and non-automatic)

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

Manufacturer: Zhengzhou Bioyuan Biotech Co. Ltd.
Manufacturer SRN: CN-MF-000021426
UDI-DI: 06974925050355
Basic UDI-DI: 697492505000003T8
Reference: BYZKC0301
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 30.06.2026 12:14

Manufacturer products Authorised representative products Authorised representative actors View details

Cardiac Markers Control

Analyzer (automatic and non-automatic)

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

Manufacturer: Zhengzhou Bioyuan Biotech Co. Ltd.
Manufacturer SRN: CN-MF-000021426
UDI-DI: 06974925050317
Basic UDI-DI: 697492505000003T8
Reference: BYZKC0201
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 30.06.2026 12:14

Manufacturer products Authorised representative products Authorised representative actors View details

Cardiac Markers Control

Analyzer (automatic and non-automatic)

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

Manufacturer: Zhengzhou Bioyuan Biotech Co. Ltd.
Manufacturer SRN: CN-MF-000021426
UDI-DI: 06974925050270
Basic UDI-DI: 697492505000003T8
Reference: BYZKC0101
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 30.06.2026 12:14

Manufacturer products Authorised representative products Authorised representative actors View details

hs-cTnI Control

hs-cTnI Control

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: SHENZHEN EVER-BLUE BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000025048
UDI-DI: 06973880815467
Basic UDI-DI: 697388081084PG
Reference: ZCC180
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 12:10

Manufacturer products Authorised representative products Authorised representative actors View details

D-dimer Control

D-dimer 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: 06973880815412
Basic UDI-DI: 697388081079PP
Reference: ZCC124
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 12:10

Manufacturer products Authorised representative products Authorised representative actors View details

NT-proBNP Control

NT-proBNP Control

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: SHENZHEN EVER-BLUE BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000025048
UDI-DI: 06973880815283
Basic UDI-DI: 697388081078PM
Reference: ZCC094
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

BNP 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: 06973880813258
Basic UDI-DI: 697388081035P3
Reference: ZCC081
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