Public EUDAMED Search

EUDAMED Device Search

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

Last updated

21.09.2026 21:15

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Device

3187538

Actor

47657

Certificate

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Active filter:EMDN:W01021311

167 device results listed.

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IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
Manufacturer
Beijing Leadman Biochemistry Co., Ltd.
Manufacturer SRN
CN-MF-000020150
UDI-DI
06954376012478
Basic UDI-DI
B-06954376012478
Reference
69543760F0001566
EMDN
W01021311
EMDN description
CREATINE KINASE - MB MASS (IC)
First on market country
Germany
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
03.08.2026 21:51
AURYX 90 CK-MB Reagent Kit

AURYX 90 CK-MB Reagent Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent
Manufacturer
PZ CORMAY Spółka Akcyjna
Manufacturer SRN
PL-MF-000023053
UDI-DI
05907514600564
Basic UDI-DI
B-05907514600564
Reference
I20-R0032
EMDN
W01021311
EMDN description
CREATINE KINASE - MB MASS (IC)
First on market country
Poland
Authorised representative
-
Last updated
03.08.2026 00:52
AURYX 90 CK-MB Reagent Kit

AURYX 90 CK-MB Reagent Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent
Manufacturer
PZ CORMAY Spółka Akcyjna
Manufacturer SRN
PL-MF-000023053
UDI-DI
05907514600557
Basic UDI-DI
B-05907514600557
Reference
I20-R0031
EMDN
W01021311
EMDN description
CREATINE KINASE - MB MASS (IC)
First on market country
Poland
Authorised representative
-
Last updated
03.08.2026 00:52
IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent
Manufacturer
Beijing Hotgen Biotech Co., Ltd.
Manufacturer SRN
CN-MF-000015566
UDI-DI
06936700403084
Basic UDI-DI
697029753043L4
Reference
HGCL02
EMDN
W01021311
EMDN description
CREATINE KINASE - MB MASS (IC)
First on market country
Germany
Authorised representative
MedNet EC-REP GmbH
Last updated
31.07.2026 21:07
CK-MB CLIA Microparticles

AutoLumo analyzer

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent
Manufacturer
Autobio Diagnostics Co., Ltd.
Manufacturer SRN
CN-MF-000003348
UDI-DI
06942359547994
Basic UDI-DI
697015090000037H7
Reference
CMH0303
EMDN
W01021311
EMDN description
CREATINE KINASE - MB MASS (IC)
First on market country
Italy
Authorised representative
QbD RepS BV
Last updated
31.07.2026 20:50
Creatine kinase MB(CLIA)

105-005662-00、105-005679-00、105-005913-00

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent
Manufacturer
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN
CN-MF-000014156
UDI-DI
06944904065243
Basic UDI-DI
69449040004L-CK-MB*****BS
Reference
105-005662-00
EMDN
W01021311
EMDN description
CREATINE KINASE - MB MASS (IC)
First on market country
Germany
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
31.07.2026 19:54
06926802603178

CK-MB(CLIA)

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use
Manufacturer
MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN
CN-MF-000005925
UDI-DI
06926802603178
Basic UDI-DI
69268026MD71C00001UJ
Reference
MCL01801E
EMDN
W01021311
EMDN description
CREATINE KINASE - MB MASS (IC)
First on market country
Netherlands
Authorised representative
R Sight B.V.
Last updated
31.07.2026 18:41
iFlash-CK-MB

iFlash-CK-MB

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
Manufacturer
SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN
CN-MF-000001137
UDI-DI
06925912711780
Basic UDI-DI
692591270042GZ
Reference
C89242-L
EMDN
W01021311
EMDN description
CREATINE KINASE - MB MASS (IC)
First on market country
Germany
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
31.07.2026 18:29
D-R1521328

200 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN
CN-MF-000011141
UDI-DI
D-R1521328
Basic UDI-DI
B-R1521328
Reference
R15213
EMDN
W01021311
EMDN description
CREATINE KINASE - MB MASS (IC)
First on market country
Ireland
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
22.07.2026 15:03
D-R1521226

100 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN
CN-MF-000011141
UDI-DI
D-R1521226
Basic UDI-DI
B-R1521226
Reference
R15212
EMDN
W01021311
EMDN description
CREATINE KINASE - MB MASS (IC)
First on market country
Ireland
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
22.07.2026 15:03
D-R152142A

50 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN
CN-MF-000011141
UDI-DI
D-R152142A
Basic UDI-DI
B-R152142A
Reference
R15214
EMDN
W01021311
EMDN description
CREATINE KINASE - MB MASS (IC)
First on market country
Ireland
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
22.07.2026 15:02
D-R1521124

50 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN
CN-MF-000011141
UDI-DI
D-R1521124
Basic UDI-DI
B-R1521124
Reference
R15211
EMDN
W01021311
EMDN description
CREATINE KINASE - MB MASS (IC)
First on market country
Ireland
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
22.07.2026 15:02
D-R03219ZQ

R1: 30ml×4, R2: 15ml×2

IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN
CN-MF-000011141
UDI-DI
D-R03219ZQ
Basic UDI-DI
B-R03219ZQ
Reference
R03219
EMDN
W01021311
EMDN description
CREATINE KINASE - MB MASS (IC)
First on market country
Ireland
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
22.07.2026 14:52
D-R03218ZN

R1: 40ml×4, R2: 18ml×2

IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN
CN-MF-000011141
UDI-DI
D-R03218ZN
Basic UDI-DI
B-R03218ZN
Reference
R03218
EMDN
W01021311
EMDN description
CREATINE KINASE - MB MASS (IC)
First on market country
Ireland
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
22.07.2026 14:52
D-R03217ZL

R1: 60ml×4, R2: 30ml×2

IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN
CN-MF-000011141
UDI-DI
D-R03217ZL
Basic UDI-DI
B-R03217ZL
Reference
R03217
EMDN
W01021311
EMDN description
CREATINE KINASE - MB MASS (IC)
First on market country
Ireland
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
22.07.2026 14:52
D-R03216ZJ

R1: 25ml×4, R2: 25ml×1

IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN
CN-MF-000011141
UDI-DI
D-R03216ZJ
Basic UDI-DI
B-R03216ZJ
Reference
R03216
EMDN
W01021311
EMDN description
CREATINE KINASE - MB MASS (IC)
First on market country
Ireland
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
22.07.2026 14:52
D-R03215ZG

R1: 20ml×4, R2: 20ml×1

IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN
CN-MF-000011141
UDI-DI
D-R03215ZG
Basic UDI-DI
B-R03215ZG
Reference
R03215
EMDN
W01021311
EMDN description
CREATINE KINASE - MB MASS (IC)
First on market country
Ireland
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
22.07.2026 14:52
D-R03214ZE

R1:50ml×4,R2:25ml×2

IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN
CN-MF-000011141
UDI-DI
D-R03214ZE
Basic UDI-DI
B-R03214ZE
Reference
R03214
EMDN
W01021311
EMDN description
CREATINE KINASE - MB MASS (IC)
First on market country
Ireland
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
22.07.2026 14:52
D-R03212ZA

R1:40ml×4,R2:20ml×2

IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN
CN-MF-000011141
UDI-DI
D-R03212ZA
Basic UDI-DI
B-R03212ZA
Reference
R03212
EMDN
W01021311
EMDN description
CREATINE KINASE - MB MASS (IC)
First on market country
Ireland
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
22.07.2026 14:52