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Sign in to claim this brandBiobase 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
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- XuMeng Zhang
- EUDAMED SRN
- CN-MF-000025015
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (1003)
Page 19 of 21| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Transferrin (TRF) Test Kit (Immunoturbidimetric) | Calibrator：1mL×1(91005) | EUDAMEDFDA UDI | IVD General | Active |
| Lactate Dehydrogenase (LDH)Test Kit (DGKC) | R1:80mL×2 R2:20mL×2（706） | EUDAMEDFDA UDI | IVD General | Active |
| Ferritin (Fet)Test Kit (Latex Enhanced Immunoturbidimetric) | R1:20mL×1 R2:10mL×1 | EUDAMED | IVD General | Active |
| Angiotensin Converting Enzyme (ACE) Test Kit (Colorimetric) | Calibrator：1mL×1(91132) | EUDAMEDFDA UDI | IVD General | Active |
| 5-Part Auto Hematology Analyzer | BS009 | EUDAMED | Class A | Active |
| Homocysteine (HCY) Test Kit (Enzymatic) | R1:40mL×5 R2:13mL×5（795） | EUDAMED | IVD General | Active |
| Automatic ELISA Processor | BS001 | EUDAMEDFDA UDI | Class A | Active |
| Albumin (ALB) Test Kit (BCG ) | R:100mL×2（708） | EUDAMED | IVD General | Active |
| Electrolyte Analyzer | BS006 | EUDAMEDFDA UDI | Class A | Active |
| Direct Bilirubin (DBIL) Test Kit (DCA) | R1:48mL×2 R2:12mL×2（715） | EUDAMED | IVD General | Active |
| Retinol-binding Protein (RBP) Test Kit (Immunoturbidimetric) | R1:18mL×1 R2:6mL×1（702） | EUDAMEDFDA UDI | IVD General | Active |
| Prealbumin (PALB) Test Kit (Immunoturbidimetric) | R1:90mL×1 R2:30mL×1(708) | EUDAMEDFDA UDI | IVD General | Active |
| Automatic Chemistry Analyzer | BS003 | EUDAMEDFDA UDI | Class A | Active |
| Angiotensin Converting Enzyme (ACE) Test Kit (Colorimetric) | R:20mL×8（709） | EUDAMEDFDA UDI | IVD General | Active |
| Transferrin (TRF) Test Kit (Immunoturbidimetric) | R1:18mL×4 R2:6mL×4(709) | EUDAMEDFDA UDI | IVD General | Active |
| Creatine Kinase-MB (CK-MB) Test Kit (Immune Suppression) | R1:48mL×2 R2:12mL×2（715） | EUDAMED | IVD General | Active |
| Total Bile Acid (TBA) Test Kit (Enzymatic Cycling) | R1:48mL×2 R2:16mL×2（791） | EUDAMED | IVD General | Active |
| Urinary Total Protein (UTP) Test Kit (Colorimetric) | Quality Control：1mL×1（92028） | EUDAMEDFDA UDI | IVD General | Active |
| Prealbumin (PALB) Test Kit (Immunoturbidimetric) | R1:48mL×2 R2:16mL×2(713) | EUDAMEDFDA UDI | IVD General | Active |
| Medical Centrifuge | BS014 | EUDAMEDFDA UDI | Class I | Active |
| Pepsinogen II (PG II) Test Kit (Immunoturbidimetric) | R1:25mL×1 R2:5mL×1(702) | EUDAMED | IVD General | Active |
| Unsaturated Iron Binding Capacity (UIBC) Test Kit (Ferene) | R1:64mL×2 R2:16mL×2（701） | EUDAMEDFDA UDI | IVD General | Active |
| Albumin (ALB) Test Kit (BCG ) | R:60mL×2（701） | EUDAMED | IVD General | Active |
| Total Bilirubin (TBIL) Test Kit (Vanadate Oxidation) | R1:40mL×4 R2:20mL×2（704） | EUDAMED | IVD General | Active |
| Non-esterified Fatty Acid (NEFA) Test Kit (ACS-PAP) | Calibrator：1mL×1（91058） | EUDAMED | IVD General | Active |
| Adenosine Deaminase (ADA)Test Kit (Enzymatic) | R1:40mL×4 R2:20mL×4（704） | EUDAMED | IVD General | Active |
| Glycohemoglobin A1c (HbA1c) Test Kit (Latex Enhanced Immunoturbidimetric) | R1:30mL×1 R2:10mL×1（715） | EUDAMED | IVD General | Active |
| α-Hydroxybutyrate Dehydrogenase (α-HBDH) Test Kit (DGKC) | R1:64mL×2 R2:16mL×2（701） | EUDAMEDFDA UDI | IVD General | Active |
| Prealbumin (PALB) Test Kit (Immunoturbidimetric) | R1:18mL×1 R2:6mL×1(702) | EUDAMEDFDA UDI | IVD General | Active |
| Lipase (LPS) Test Kit (Enzymatic Colorimetric) | R1:40mL×2 R2:20mL×2(701) | EUDAMEDFDA UDI | IVD General | Active |
| Cholinesterase (CHE) Test Kit (Butyrylthiocholine ) | R1:100mL×1 R2:20mL×1（708） | EUDAMEDFDA UDI | IVD General | Active |
| Serum Amyloid A Protein (SAA) Assay Test Kit (Latex immune turbidity Method) | R1:48mL×2 R2:16mL×2(792) | EUDAMED | IVD General | Active |
| Homocysteine (HCY) Test Kit (Enzymatic) | R1:20mL×4 R2:6.5mL×4（709） | EUDAMED | IVD General | Active |
| Myeloperoxidase (MPO) Assay Test Kit (Immunoturbidimetric Method) | R1:18mL×4 R2:6mL×4(709) | EUDAMED | IVD General | Active |
| Glycohemoglobin A1c (HbA1c) Test Kit (Latex Enhanced Immunoturbidimetric) | R1:30mL×1 R2:10mL×1（702） | EUDAMED | IVD General | Active |
| Lactate Dehydrogenase (LDH)Test Kit (DGKC) | R1:40mL×4 R2:20mL×2（704） | EUDAMEDFDA UDI | IVD General | Active |
| Total Protein (TP) Test Kit (Biuret) | R:40mL×4（705） | EUDAMEDFDA UDI | IVD General | Active |
| Homocysteine (HCY) Test Kit (Enzymatic) | R1:40mL×2 R2:13mL×2（716） | EUDAMED | IVD General | Active |
| Adenosine Deaminase (ADA)Test Kit (Enzymatic) | Calibrator:1mL×1（91006） | EUDAMED | IVD General | Active |
| "Serum Amyloid A Protein (SAA) Assay Test Kit (Latex immune turbidity Method)" | R1:48mL×2 R2:16mL×2(705) | EUDAMED | IVD General | Active |
| Total Protein (TP) Test Kit (Biuret) | R:20mL×2（702） | EUDAMEDFDA UDI | IVD General | Active |
| Medical Centrifuge | BS014 | EUDAMEDFDA UDI | Class I | Active |
| Adenosine Deaminase (ADA)Test Kit (Enzymatic) | R1:20mL×4 R2:10mL×4（709） | EUDAMED | IVD General | Active |
| Creatine Kinase (CK)Test Kit(IFCC) | R1:48mL×2 R2:12mL×2（715） | EUDAMED | IVD General | Active |
| Transferrin (TRF) Test Kit (Immunoturbidimetric) | R1:48mL×2 R2:16mL×2(705) | EUDAMEDFDA UDI | IVD General | Active |
| Biological Safety Cabinet | BS015 | EUDAMED | Class I | Active |
| Immune Globulin E (IgE) Test Kit (Immunoturbidimetric) | Calibrator：1mL×5（91041） | EUDAMED | IVD General | Active |
| Non-esterified Fatty Acid (NEFA) Test Kit (ACS-PAP) | R1:20mL×1 R2:5mL×1（702） | EUDAMED | IVD General | Active |
| Automatic Chemistry Analyzer | BS003 | EUDAMEDFDA UDI | Class A | Active |
| Total Bilirubin (TBIL) Test Kit (DCA) | R1:100mL×1 R2:25mL×1（708） | EUDAMED | IVD General | Active |
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