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EUDAMED Device Search

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

Last updated

31.07.2026 19:58

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Active filter:EMDN:W01021309

7 device results listed.

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Ischemia-Modified Albumin Assay Kit (Albumin-cobalt Binding Method)

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Shanghai Kehua Bio-engineering Co., Ltd.
Manufacturer SRN: CN-MF-000026756
UDI-DI: D-1877F
Basic UDI-DI: B-1877F
Reference: /
EMDN: W01021309
EMDN description: ISCHEMIA MODIFIED ALBUMIN
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 11.07.2026 10:58

Manufacturer products Authorised representative products Authorised representative actors View details

R1: 2×60 mL, R2: 2×20 mL

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Shenzhen AmTech Bioengineering Ltd., Inc.
Manufacturer SRN: CN-MF-000043067
UDI-DI: 06974760129865
Basic UDI-DI: B-06974760129865
Reference: R1: 2×60 mL, R2: 2×20 mL
EMDN: W01021309
EMDN description: ISCHEMIA MODIFIED ALBUMIN
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 20:41

Manufacturer products Authorised representative products Authorised representative actors View details

Ischemia Modified Albumin (IMA) Test Kit(Colorimetric)

R1:20mL×1 R2:10mL×1（702）

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06971674869245
Basic UDI-DI: B-06971674869245
Reference: R1:20mL×1 R2:10mL×1（702）
EMDN: W01021309
EMDN description: ISCHEMIA MODIFIED ALBUMIN
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 13:42

Manufacturer products Authorised representative products Authorised representative actors View details

Ischemia Modified Albumin (IMA) Test Kit(Colorimetric)

R1:20mL×4 R2:10mL×4（709）

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06971674869238
Basic UDI-DI: B-06971674869238
Reference: R1:20mL×4 R2:10mL×4（709）
EMDN: W01021309
EMDN description: ISCHEMIA MODIFIED ALBUMIN
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 13:42

Manufacturer products Authorised representative products Authorised representative actors View details

Ischemia Modified Albumin (IMA) Test Kit(Colorimetric)

R1:40mL×2 R2:20mL×2（701）

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06971674869221
Basic UDI-DI: B-06971674869221
Reference: R1:40mL×2 R2:20mL×2（701）
EMDN: W01021309
EMDN description: ISCHEMIA MODIFIED ALBUMIN
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 13:42

Manufacturer products Authorised representative products Authorised representative actors View details

Ischemia Modified Albumin (IMA) Test Kit(Colorimetric)

Quality Control：1mL×1（92029）

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06971674868408
Basic UDI-DI: B-06971674868408
Reference: Quality Control：1mL×1（92029）
EMDN: W01021309
EMDN description: ISCHEMIA MODIFIED ALBUMIN
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 13:39

Manufacturer products Authorised representative products Authorised representative actors View details

Ischemia Modified Albumin (IMA) Test Kit(Colorimetric)

Calibrator：1mL×2（91039）

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06971674868057
Basic UDI-DI: B-06971674868057
Reference: Calibrator：1mL×2（91039）
EMDN: W01021309
EMDN description: ISCHEMIA MODIFIED ALBUMIN
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 13:37

Manufacturer products Authorised representative products Authorised representative actors View details