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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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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

Urinary Total Protein (UTP) Test Kit (Colorimetric)

Quality Control：1mL×1（92028）

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06971674868392
Basic UDI-DI: B-06971674868392
Reference: Quality Control：1mL×1（92028）
EMDN: W01010230
EMDN description: TOTAL PROTEIN
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 13:39

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Retinol-binding Protein (RBP) Test Kit (Immunoturbidimetric)

Quality Control：1mL×1（92027）

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06971674868385
Basic UDI-DI: B-06971674868385
Reference: Quality Control：1mL×1（92027）
EMDN: W0102010306
EMDN description: RETINOL BINDING PROTEIN
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 13:39

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Troponin I (TnI) Test Kit (Latex Enhanced Immunoturbidimetric)

Quality Control：1mL×2（92026）

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06971674868378
Basic UDI-DI: B-06971674868378
Reference: Quality Control：1mL×2（92026）
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 13:39

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Angiotensin Converting Enzyme (ACE) Test Kit (Colorimetric)

Quality Control：1mL×1(92145)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06971674868361
Basic UDI-DI: B-06971674868361
Reference: Quality Control：1mL×1(92145)
EMDN: W01010109
EMDN description: ANGIOTENSIN CONVERTING ENZYME (CC)
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 13:39

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Glycosylated Hemoglobin (HbA1c)Test Kit (Enzymatic)

质控品：1mL×2（92143）

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06971674868354
Basic UDI-DI: B-06971674868354
Reference: 质控品：1mL×2（92143）
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
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

Monoamine Oxidase (MAO) Test Kit (Glutamate Dehydrogenase)

质控品：1mL×1（92023）

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06971674868347
Basic UDI-DI: B-06971674868347
Reference: 质控品：1mL×1（92023）
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
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

Microalbuminuria (MALB) Test Kit (Immunoturbidimetric)

Quality Control:1mL×1（92022）

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06971674868330
Basic UDI-DI: B-06971674868330
Reference: Quality Control:1mL×1（92022）
EMDN: W0102010309
EMDN description: ALBUMIN (IC) INCL. UALBUMIN
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

Ammonia (AMM) Test Kit (Glutamate Dehydrogenase)

质控品：3mL×1（92138）

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06971674868323
Basic UDI-DI: B-06971674868323
Reference: 质控品：3mL×1（92138）
EMDN: W01010301
EMDN description: AMMONIA
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

D-Dimer (DD) Test Kit (Immunoturbidimetric)

Quality Control：1mL×2(92146)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06971674868293
Basic UDI-DI: B-06971674868293
Reference: Quality Control：1mL×2(92146)
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 13:38

Manufacturer products Authorised representative products Authorised representative actors View details

Glycosylated Hemoglobin (HbA1c)Test Kit (Enzymatic)

质控品：0.5mL×2（92142）

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06971674868286
Basic UDI-DI: B-06971674868286
Reference: 质控品：0.5mL×2（92142）
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 13:38

Manufacturer products Authorised representative products Authorised representative actors View details

N-Acetyl-β-D-Glucosaminidase (NAG) Test Kit (Colorimetric)

质控品：2mL×1（92147）

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06971674868316
Basic UDI-DI: B-06971674868316
Reference: 质控品：2mL×1（92147）
EMDN: W01010126
EMDN description: N-ACETYL-B, D-GLUCOSAMINIDASE
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 13:38

Manufacturer products Authorised representative products Authorised representative actors View details

Homocysteine (HCY) Test Kit (Enzymatic)

质控品：1mL×1（92141）

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06971674868309
Basic UDI-DI: B-06971674868309
Reference: 质控品：1mL×1（92141）
EMDN: W01021307
EMDN description: HOMOCYSTEINE
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 13:38

Manufacturer products Authorised representative products Authorised representative actors View details

Pepsinogen I (PG I) Test Kit (Immunoturbidimetric)

Quality Control：1mL×2(92014)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06971674868279
Basic UDI-DI: B-06971674868279
Reference: Quality Control：1mL×2(92014)
EMDN: W01010127
EMDN description: PEPSIN
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 13:38

Manufacturer products Authorised representative products Authorised representative actors View details

Cystatin C (CYS-C) Test Kit (Immunoturbidimetric)

质控品：1mL×2（92013）

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06971674868262
Basic UDI-DI: B-06971674868262
Reference: 质控品：1mL×2（92013）
EMDN: W0102019008
EMDN description: CYSTATIN C
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 13:38

Manufacturer products Authorised representative products Authorised representative actors View details

Apolipoprotein E (APOE) Test Kit (Immunoturbidimetric)

质控品：1mL×1（92012）

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06971674868255
Basic UDI-DI: B-06971674868255
Reference: 质控品：1mL×1（92012）
EMDN: W0102010404
EMDN description: APOLIPOPROTEIN E SUB-TYPING
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 13:38

Manufacturer products Authorised representative products Authorised representative actors View details

Myoglobin (MB) Test Kit (Immunoturbidimetric)

质控品：3mL×2（92011）

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06971674868248
Basic UDI-DI: B-06971674868248
Reference: 质控品：3mL×2（92011）
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 13:38

Manufacturer products Authorised representative products Authorised representative actors View details

5′-Nucleotidase (5’-NT) Test Kit (Colorimetric)

质控品：1mL×1（92137）

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06971674868231
Basic UDI-DI: B-06971674868231
Reference: 质控品：1mL×1（92137）
EMDN: W01010101
EMDN description: 5'-NUCLEOTIDASE
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 13:38

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine Kinase-MB (CK-MB) Test Kit (Immune Suppression)

Quality Control: 2mL×1（92104）

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06971674868217
Basic UDI-DI: B-06971674868217
Reference: Quality Control: 2mL×1（92104）
EMDN: W01010115
EMDN description: CREATINE KINASE ISOENZYMES
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 13:38

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Glycosylated Serum Proteins (GSP) Test Kit (Tetrazolium Blue)

Quality Control:1mL×1（92105）

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06971674868224
Basic UDI-DI: B-06971674868224
Reference: Quality Control:1mL×1（92105）
EMDN: W01010210
EMDN description: FRUCTOSAMINE
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 13:38

Manufacturer products Authorised representative products Authorised representative actors View details