Chongqing iSIA BIO-Technology Co., Ltd.
Active in EUDAMEDChinafrom SRN EUDAMED SRN CN-MF-000003364
- Devices
- 356
- Registrations
- EUDAMED
What Chongqing iSIA BIO-Technology Co., Ltd. makes
The company produces diagnostic test kits and immunoanalyzers for cardiac biomarkers, including the N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) and Troponin I (cTnI) rapid test kits, both using quantum dot-based immunofluorescence methods. It also manufactures fluorescent immuno analyzers designed for laboratory use in detecting and quantifying these biomarkers in patient samples.
These devices fall under EU regulatory classifications of Class A and Class C, with relevant information recorded in the euDAMED database. The company is based in China and adheres to applicable regulatory requirements for in vitro diagnostic medical devices.
AI-generated from registry data, 19 Sep 2026. Not verified by deviCERTS or the manufacturer.
DeviceDevice · Authorizations Verified Status Regime Registry Class
- Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General
- Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General
- Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General
- Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General
- Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General
Control For Troponin T (cTnT) Ref 069Z
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General- Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General
Control For Microalbumin (MALB) Ref 0B8Z
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General- Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General
- Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General
- Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General
- Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General
- Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General
- Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General
- Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General
- Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General
- Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General
Testosterone (T) Test Kit (CLIA Method) Ref 2080W
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General- Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General
Control For S100-beta (S100-β) Ref 033Z
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General- Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General
- Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General
- Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General
- Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General
- Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General
Control For Calprotectin (CAL) Ref 0E4Z
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General- Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General
- Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General
- Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General
- Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General
- Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General
- Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General
Neutrophil Gelatinase-Associated Lipocalin (NGAL) Rapid Test Kit (QDs immunofluorescence Method) Ref C0W
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General- Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General
- Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General
- Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General
- Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General
- Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General
- Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General
- Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General
- Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General
- Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General
- Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General
- Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General
- Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General
- Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General
- Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General
- Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General
- Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General
- Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General
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Company details
- EUDAMED SRN
- CN-MF-000003364
- EUDAMED status
- Active
- EUDAMED registered name
- Chongqing iSIA BIO-Technology Co., Ltd.
- EUDAMED abbreviated name
- iSIA
- Registered address
- No.388, Jingdongfang Avenue, 400714, Chongqing, China
- Website
- www.isiabio.com This website had an invalid or expired security certificate when we last checked. Last checked 18 Oct 2026.
- [email protected]
- Phone
- +8623 68277909
- PRRC contact
- Yunguo Zuo(public in EUDAMED)