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Biobase Biodustry(Shandong) Co.,Ltd.

China·CN-MF-000025015

Last updated June 8, 2026

What Biobase Biodustry(Shandong) Co.,Ltd. makes

Biobase Biodustry(Shandong) Co.,Ltd. manufactures in vitro diagnostic (IVD) products including nucleic acid extraction/isolation kits using magnetic bead methods, general-purpose centrifuges, and reagents for clinical chemistry and immunoassay testing such as creatinine, calcium, bilirubin, sodium, iron, apolipoprotein B, D-dimer, microalbuminuria, and virus sampling tubes.

The company's devices are classified as Class A, Class I, and IVD General under regulatory frameworks and are listed in the EUDAMED database. Biobase Biodustry(Shandong) Co.,Ltd. is based in China (CN).

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What does Biobase Biodustry(Shandong) Co.,Ltd. make?

Biobase Biodustry(Shandong) Co.,Ltd. manufactures in vitro diagnostic (IVD) products such as nucleic acid extraction/isolation kits using magnetic bead methods, general-purpose centrifuges, and reagents for clinical chemistry and immunoassay testing. Examples include test kits for creatinine, calcium, bilirubin, sodium, iron, apolipoprotein B, D-dimer, microalbuminuria, and virus sampling tubes. These devices are designed for laboratory use in detecting biological markers.

Where is Biobase Biodustry(Shandong) Co.,Ltd. based?

Biobase Biodustry(Shandong) Co.,Ltd. is based in China, as indicated by the country code CN in the provided data. The company's manufacturing and operational activities are located within China, though specific city or facility details are not included in the source information.

Which regulatory registries list devices from Biobase Biodustry(Shandong) Co.,Ltd.?

Devices manufactured by Biobase Biodustry(Shandong) Co.,Ltd. are listed in the EUDAMED database, which is the European Union's system for tracking medical devices and IVDs. This listing indicates that the company's products have been registered for distribution in the EU market under applicable IVD regulations.

How are the devices from Biobase Biodustry(Shandong) Co.,Ltd. classified?

The devices produced by Biobase Biodustry(Shandong) Co.,Ltd. are classified as Class A, Class I, and IVD General under regulatory frameworks. These classifications reflect the risk level and intended use of the products, with Class A and IVD General typically applying to lower-risk in vitro diagnostic devices such as reagents and basic laboratory instruments.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
China
Address
Mingshui Economic Devlopment Zone, Zhangqiu Dsitrict, Jinan City, China
Website
biobase.cn
LinkedIn
—
Facebook
—
Email
[email protected]
Phone
—
PRRC Contact
XuMeng Zhang
EUDAMED SRN
CN-MF-000025015
FDA FEI Number
—
DUNS Number
—

Catalogue (1003)

Page 17 of 21
DeviceModel / ReferenceRegistriesClassStatus
Automated Blood Culture System BK-BC64
EUDAMED
Class AActive
Anti-Streptolysin O (ASO) Test Kit (Immunoturbidimetric) R1:64mL×2 R2:16mL×2(701)
EUDAMEDFDA UDI
IVD GeneralActive
Procalcitonin (PCT) Test Kit (Latex Immunoturbidimetric) Quality Control：1mL×1（92051）
EUDAMED
IVD GeneralActive
Urinary Total Protein (UTP) Test Kit (Colorimetric) R:60mL×2（717）
EUDAMEDFDA UDI
IVD GeneralActive
Glutamate Dehydrogenase (GLDH) Test Kit (Enzymatic) R1:100mL×1 R2:25mL×1（708）
EUDAMED
IVD GeneralActive
Creatine Kinase-MB (CK-MB) Test Kit (Immune Suppression) R1:64mL×2 R2:16mL×2（701）
EUDAMED
IVD GeneralActive
Glycated albumin (GA) Test Kit (Peroxidase) R1:20mL×4 R2:5mL×4 R3:40mL×2（709）
EUDAMED
IVD GeneralActive
Fibronectin (Fn) Test Kit (Immunoturbidimetric) Quality Control：1mL×2（92035）
EUDAMED
IVD GeneralActive
Chlorine (Cl-) Test Kit (Mercuric Thiocyanate) R:40mL×4（715）
EUDAMED
IVD GeneralActive
Direct Bilirubin (DBIL) Test Kit (DCA) R1:48mL×2 R2:24mL×1（791）
EUDAMED
IVD GeneralActive
Angiotensin Converting Enzyme (ACE) Test Kit (Colorimetric) Quality Control：1mL×1(92145)
EUDAMEDFDA UDI
IVD GeneralActive
α1-microglobulin (α1-MG) Test Kit (Latex Enhanced Immunoturbidimetric) R1:20mL×4 R2:5mL×4（709）
EUDAMEDFDA UDI
IVD GeneralActive
Total Bilirubin (TBIL) Test Kit (DCA) R1:48mL×2 R2:12mL×2（798）
EUDAMED
IVD GeneralActive
Lipase (LPS) Test Kit (Enzymatic Colorimetric) R1:20mL×4 R2:10mL×4(709)
EUDAMEDFDA UDI
IVD GeneralActive
α-Hydroxybutyrate Dehydrogenase (α-HBDH) Test Kit (DGKC) R1:20mL×4 R2:5mL×4（796）
EUDAMEDFDA UDI
IVD GeneralActive
Cholinesterase (CHE) Test Kit (Butyrylthiocholine ) R1:80mL×2 R2:16mL×2（706）
EUDAMEDFDA UDI
IVD GeneralActive
Direct Bilirubin (DBIL) Test Kit (DCA) R1:20mL×4 R2:5mL×4（796）
EUDAMED
IVD GeneralActive
Unsaturated Iron Binding Capacity (UIBC) Test Kit (Ferene) R1:20mL×4 R2:5mL×4（709）
EUDAMEDFDA UDI
IVD GeneralActive
Myeloperoxidase (MPO) Assay Test Kit (Immunoturbidimetric Method) R1:48mL×2 R2:16mL×2(716)
EUDAMED
IVD GeneralActive
Lactate Dehydrogenase (LDH)Test Kit (DGKC) R1:100mL×1 R2:25mL×1（708）
EUDAMEDFDA UDI
IVD GeneralActive
Urinary Total Protein (UTP) Test Kit (Colorimetric) R:20mL×8（709）
EUDAMEDFDA UDI
IVD GeneralActive
Total Bilirubin (TBIL) Test Kit (DCA) R1:80mL×1 R2:20mL×1（703）
EUDAMED
IVD GeneralActive
Transferrin (TRF) Test Kit (Immunoturbidimetric) R1:18mL×1 R2:6mL×1(702)
EUDAMEDFDA UDI
IVD GeneralActive
Total Bile Acid (TBA) Test Kit (Enzymatic Cycling) R1:48mL×2 R2:16mL×2（798）
EUDAMED
IVD GeneralActive
Procalcitonin (PCT) Test Kit (Latex Immunoturbidimetric) R1:64mL×2 R2:16mL×2（701）
EUDAMED
IVD GeneralActive
Transferrin (TRF) Test Kit (Immunoturbidimetric) R1:48mL×2 R2:16mL×2(713)
EUDAMEDFDA UDI
IVD GeneralActive
"Serum Amyloid A Protein (SAA) Assay Test Kit (Latex immune turbidity Method)" R1:48mL×2 R2:16mL×2(793)
EUDAMED
IVD GeneralActive
Unsaturated Iron Binding Capacity (UIBC) Test Kit (Ferene) Calibrator：1mL×1（91100）
EUDAMED
IVD GeneralActive
Alpha-L-Fucosidase (AFU) Test Kit (CNPF Substrate Method) R：40mL×4(704018)
EUDAMED
IVD GeneralActive
α1-microglobulin (α1-MG) Test Kit (Latex Enhanced Immunoturbidimetric) R1:20mL×1 R2:5mL×1（702）
EUDAMEDFDA UDI
IVD GeneralActive
Chlorine (Cl-) Test Kit (Mercuric Thiocyanate) R:40mL×4（716）
EUDAMED
IVD GeneralActive
Urinary Total Protein (UTP) Test Kit (Colorimetric) R:50mL×2（701）
EUDAMEDFDA UDI
IVD GeneralActive
Lipase (LPS) Test Kit (Enzymatic Colorimetric) R1:100mL×1 R2:50mL×1(708)
EUDAMEDFDA UDI
IVD GeneralActive
Creatine Kinase (CK)Test Kit(IFCC) R1:40mL×4 R2:20mL×2（704）
EUDAMED
IVD GeneralActive
Automated Sample Processing System BS003
EUDAMEDFDA UDI
Class AActive
Anti cyclic citrullinated peptide antibody (CCP) Test kit (Latex Immunoturbidimetric) R1:18mL×1 R2:6mL×1
EUDAMED
IVD GeneralActive
Total Bile Acid (TBA) Test Kit (Enzymatic Cycling) R1:60mL×2 R2:20mL×2（706）
EUDAMED
IVD GeneralActive
Myeloperoxidase (MPO) Assay Test Kit (Immunoturbidimetric Method) R1:48mL×2 R2:16mL×2(798)
EUDAMED
IVD GeneralActive
Glycated albumin (GA) Test Kit (Peroxidase) Quality Control：1mL×1（92052）
EUDAMED
IVD GeneralActive
α-Hydroxybutyrate Dehydrogenase (α-HBDH) Test Kit (DGKC) R1:48mL×2 R2:12mL×2（716）
EUDAMEDFDA UDI
IVD GeneralActive
Serum Amyloid A Protein (SAA) Assay Test Kit (Latex immune turbidity Method) R1:90mL×1 R2:30mL×1(708)
EUDAMED
IVD GeneralActive
Lipase (LPS) Test Kit (Enzymatic Colorimetric) R1:40mL×4 R2:20mL×4(704)
EUDAMEDFDA UDI
IVD GeneralActive
Total Bilirubin (TBIL) Test Kit (DCA) R1:48mL×2 R2:12mL×2（713）
EUDAMED
IVD GeneralActive
Anti cyclic citrullinated peptide antibody (CCP) Test kit (Latex Immunoturbidimetric) R1:60mL×2 R2:20mL×2（701）
EUDAMED
IVD GeneralActive
Albumin (ALB) Test Kit (BCG ) R:70mL×2（700）
EUDAMED
IVD GeneralActive
Total Bile Acid (TBA) Test Kit (Enzymatic Cycling) R1:18mL×1 R2:6mL×1（702）
EUDAMED
IVD GeneralActive
Total Bilirubin (TBIL) Test Kit (DCA) R1:64mL×6 R2:48mL×2（795）
EUDAMED
IVD GeneralActive
Cholinesterase (CHE) Test Kit (Butyrylthiocholine ) R1:50mL×2 R2:20mL×1（791）
EUDAMEDFDA UDI
IVD GeneralActive
Cholinesterase (CHE) Test Kit (Butyrylthiocholine ) R1:60mL×2 R2:12mL×2（701）
EUDAMEDFDA UDI
IVD GeneralActive
Automated Sample Processing System BS004
EUDAMEDFDA UDI
Class AActive

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