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EUDAMED Device Search

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

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01.08.2026 09:11

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129 device results listed.

Page 6 / 7

R1: 40mL×1; R2: 10mL×1

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Da Te Bioengineering Technology Co., LTD.
Manufacturer SRN: CN-MF-000028832
UDI-DI: 06975225461605
Basic UDI-DI: B-06975225461605
Reference: DTSH040106
EMDN: W01010113
EMDN description: CREATINE KINASE - TOTAL
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 22:12

Manufacturer products Authorised representative products Authorised representative actors View details

R1: 20mL×1; R2: 5mL×1

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Da Te Bioengineering Technology Co., LTD.
Manufacturer SRN: CN-MF-000028832
UDI-DI: 06975225461599
Basic UDI-DI: B-06975225461599
Reference: DTSH040105
EMDN: W01010113
EMDN description: CREATINE KINASE - TOTAL
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 22:12

Manufacturer products Authorised representative products Authorised representative actors View details

R1: 2×60 mL, R2: 2×15 mL

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Shenzhen AmTech Bioengineering Ltd., Inc.
Manufacturer SRN: CN-MF-000043067
UDI-DI: 06974760129612
Basic UDI-DI: B-06974760129612
Reference: R1: 2×60 mL, R2: 2×15 mL
EMDN: W01010113
EMDN description: CREATINE KINASE - TOTAL
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 20:40

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine Kinase (CK) Kit (Rate Method)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06973262865837
Basic UDI-DI: B-06973262865837
Reference: 01.09.04.03.EC.01
EMDN: W01010113
EMDN description: CREATINE KINASE - TOTAL
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 16:56

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine Kinase (CK)Test Kit(IFCC)

R1:48mL×2 R2:12mL×2（716）

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06971674863632
Basic UDI-DI: B-06971674863632
Reference: R1:48mL×2 R2:12mL×2（716）
EMDN: W01010113
EMDN description: CREATINE KINASE - TOTAL
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 13:19

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine Kinase (CK)Test Kit(IFCC)

R1:48mL×2 R2:12mL×2（713）

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06971674863618
Basic UDI-DI: B-06971674863618
Reference: R1:48mL×2 R2:12mL×2（713）
EMDN: W01010113
EMDN description: CREATINE KINASE - TOTAL
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 13:19

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine Kinase (CK)Test Kit(IFCC)

R1:48mL×2 R2:12mL×2（715）

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06971674863625
Basic UDI-DI: B-06971674863625
Reference: R1:48mL×2 R2:12mL×2（715）
EMDN: W01010113
EMDN description: CREATINE KINASE - TOTAL
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 13:19

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine Kinase (CK)Test Kit(IFCC)

R1:20mL×4 R2:5mL×4（796）

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06971674863601
Basic UDI-DI: B-06971674863601
Reference: R1:20mL×4 R2:5mL×4（796）
EMDN: W01010113
EMDN description: CREATINE KINASE - TOTAL
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 13:19

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine Kinase (CK)Test Kit(IFCC)

R1:48mL×2 R2:24mL×1（792）

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06971674863595
Basic UDI-DI: B-06971674863595
Reference: R1:48mL×2 R2:24mL×1（792）
EMDN: W01010113
EMDN description: CREATINE KINASE - TOTAL
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 13:19

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine Kinase (CK)Test Kit(IFCC)

R1:48mL×2 R2:24mL×1（791）

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06971674863588
Basic UDI-DI: B-06971674863588
Reference: R1:48mL×2 R2:24mL×1（791）
EMDN: W01010113
EMDN description: CREATINE KINASE - TOTAL
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 13:19

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine Kinase (CK)Test Kit(IFCC)

R1:100mL×1 R2:25mL×1（708）

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06971674863571
Basic UDI-DI: B-06971674863571
Reference: R1:100mL×1 R2:25mL×1（708）
EMDN: W01010113
EMDN description: CREATINE KINASE - TOTAL
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 13:19

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine Kinase (CK)Test Kit(IFCC)

R1:48mL×2 R2:12mL×2（705）

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06971674863564
Basic UDI-DI: B-06971674863564
Reference: R1:48mL×2 R2:12mL×2（705）
EMDN: W01010113
EMDN description: CREATINE KINASE - TOTAL
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 13:19

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine Kinase (CK)Test Kit(IFCC)

R1:40mL×4 R2:20mL×2（704）

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06971674863557
Basic UDI-DI: B-06971674863557
Reference: R1:40mL×4 R2:20mL×2（704）
EMDN: W01010113
EMDN description: CREATINE KINASE - TOTAL
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 13:19

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine Kinase (CK)Test Kit(IFCC)

R1:20mL×1 R2:5mL×1（702）

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06971674863540
Basic UDI-DI: B-06971674863540
Reference: R1:20mL×1 R2:5mL×1（702）
EMDN: W01010113
EMDN description: CREATINE KINASE - TOTAL
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 13:19

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine Kinase (CK)Test Kit(IFCC)

R1:20mL×4 R2:5mL×4（709）

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06971674863533
Basic UDI-DI: B-06971674863533
Reference: R1:20mL×4 R2:5mL×4（709）
EMDN: W01010113
EMDN description: CREATINE KINASE - TOTAL
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 13:19

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine Kinase (CK)Test Kit(IFCC)

R1:64mL×2 R2:16mL×2（701）

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06971674863526
Basic UDI-DI: B-06971674863526
Reference: R1:64mL×2 R2:16mL×2（701）
EMDN: W01010113
EMDN description: CREATINE KINASE - TOTAL
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 13:19

Manufacturer products Authorised representative products Authorised representative actors View details

CK (IFCC)

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153818288
Basic UDI-DI: 6438153BU00159C7
Reference: 981828
EMDN: W01010113
EMDN description: CREATINE KINASE - TOTAL
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:07

Manufacturer products View details

CK BM 100 / BM 200

IVD Class BIVDR 2017/746On the marketProfessional testing

Manufacturer: BioMaxima Spółka Akcyjna
Manufacturer SRN: PL-MF-000039473
UDI-DI: 05902643961777
Basic UDI-DI: 59026439BBCH233AG
Reference: 1-233-0060
EMDN: W01010113
EMDN description: CREATINE KINASE - TOTAL
First on market country: Poland
Authorised representative: -
Last updated: 02.07.2026 05:23

Manufacturer products View details

CK

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Medicon Hellas SA
Manufacturer SRN: GR-MF-000013625
UDI-DI: 05204309031313
Basic UDI-DI: 5204309000014NM
Reference: 1418-0097
EMDN: W01010113
EMDN description: CREATINE KINASE - TOTAL
First on market country: Greece
Authorised representative: -
Last updated: 02.07.2026 02:52

Manufacturer products View details

0018164640

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: Instrumentation Laboratory SpA
Manufacturer SRN: IT-MF-000009277
UDI-DI: 08426951394050
Basic UDI-DI: 84269513940508Y
Reference: 0018164640
EMDN: W01010113
EMDN description: CREATINE KINASE - TOTAL
First on market country: Italy
Authorised representative: -
Last updated: 30.06.2026 15:25

Manufacturer products View details