Micropoint Biotechnologies Co., Ltd.
China CN-MF-000007991 Last updated 21 Oct 2026
- Devices
- 39
- Registries
- EUDAMED
- FDA recalls
- 0
Catalogue
qLabs® PT-INR Test Strips Ref QS-1-24 Pro
qLabs® ElectroMeter Ref Q-3
qLabs® FIB Controls Level 1 Ref QS-18-CLN
qLabs® FIB Controls Level 2 Ref QS-18-CLP
mLabs® Multi-level TnI Controls Ref M101-091007
mLabs® Multi-level CRP Controls Ref M101-091025
qLabs® Multi-level Coag Controls Ref QS-6-CL Pro
qLabs® FIB Test Strips Ref QS-18 Pro
mLabs® PCT Ref M101-091010
qLabs® Coag Panel 2 Liquid Control Ref QS-4-CL Pro
qLabs® PT-INR Liquid Control Ref QS-1-CL Pro
mLabs® Multi-level PCT Controls Ref M101-091009
qLabs® Coag Panel 2 Test Strips Ref QS-4 Pro
qLabs® PT-INR Test Strips Ref QS-1-12
qLabs® PT-INR Owren (Dry) Test Strips Ref QS-2 Pro
mLabs® CRP Ref M101-091015
mLabs® NT-proBNP Ref M101-091005
qLabs® APTT Liquid Control Ref QS-9-CL Pro
qLabs® PT-INR Test Strips Ref QS-1-48 Pro
mLabs® D-Dimer Ref M101-091001
mLabs® BNP Ref M101-091004
qLabs® APTT Test Strips Ref QS-9 Pro
mLabs® Cardiac Panel 3 Ref M101-091011
mLabs® Multi-level Cardiac Panel 3 Controls Ref M101-091012
mLabs® Multi-level NT-proBNP Controls Ref M101-091013
qLabs® PT-INR Test Strips Ref QS-1-24
mLabs® Multi-level BNP Controls Ref M101-091008
mLabs® Troponin I Ref M101-091003
mLabs® Multi-level D-Dimer Controls Ref M101-091002
qLabs® Coag Panel 4 Test Strips Ref QS-6 Pro
qLabs® Re-Calcification Reagent Ref QS-1-RC Pro
qLabs® eStation Ref MBI91-1
qLabs® ElectroMeter Plus Ref Q-2 Plus
mLabs® ImmunoMeter Ref m-101
qLabs® eStation II Ref MBI92
qLabs® ElectroMeter Ref Q-3 Plus
mLabs® Smart Ref m-20
qLabs® ElectroMeter Ref Q-1 Pro
Related companies
Authorised representatives
- Obelis s.a. BE
What Micropoint Biotechnologies Co., Ltd. makes
Micropoint Biotechnologies Co., Ltd. manufactures in vitro diagnostic (IVD) controls and test strips for clinical laboratory and point-of-care use. Their products include multi-level controls for C-reactive protein (CRP), procalcitonin (PCT), and N-terminal pro b-type natriuretic peptide (NT-proBNP), as well as coagulation panels and PT-INR test systems in both liquid and dry formats. Test strips are available for fibrinogen (FIB) and PT-INR measurements, designed for precision in diagnostic testing.
The company’s IVD devices are classified under Class A and IVD categories, including devices intended for self-testing. Their products are registered in the EU’s eudamed database, a centralised system for tracking medical devices authorised in the European Economic Area. The manufacturer is based in China.
Frequently asked questions
What types of medical devices does Micropoint Biotechnologies Co., Ltd. manufacture?
Micropoint Biotechnologies Co., Ltd. specialises in in vitro diagnostic (IVD) devices, specifically controls and test strips for clinical and point-of-care use. Their products include multi-level controls for biomarkers like CRP, PCT, and NT-proBNP, as well as coagulation panels and PT-INR test systems. These are designed to support accurate diagnostic testing in laboratories and at the point of care.
Where is Micropoint Biotechnologies Co., Ltd. based?
The company is headquartered in China. This geographic location is relevant for regulatory compliance, manufacturing standards, and distribution networks, particularly for devices intended for global markets like the European Economic Area.
Which regulatory registries list Micropoint Biotechnologies Co., Ltd.’s devices?
Micropoint Biotechnologies Co., Ltd.’s devices are registered in the eudamed database, which is the EU’s centralised system for tracking medical devices authorised within the European Economic Area. Registration in eudamed ensures transparency and compliance with EU regulatory requirements for IVD devices.
How are Micropoint Biotechnologies Co., Ltd.’s devices classified under EU regulations?
The company’s IVD devices fall under Class A classification and broader IVD General categories, including those designated for self-testing. Classification determines regulatory pathways, risk assessment, and post-market surveillance requirements, with Class A typically representing the lowest risk among IVDs.
Information
- Country
- China
- Address
- 3-5F, Building 1, Runheng Electronics Factory, Shenzhen, China
- Website
- www.micropointbio.com
- [email protected]
- Phone
- +86 755 21600849
- PRRC contact
- Huan Wang
- EUDAMED SRN
- CN-MF-000007991