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Sign in to claim this brandSichuan Orienter Biotechnology Co., Ltd.
China·CN-MF-000003026
Last updated September 18, 2026
About
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From the manufacturer's own website. Source
What Sichuan Orienter Biotechnology Co., Ltd. makes
The company manufactures chemiluminescent immunoassay kits for detecting specific biomarkers in clinical samples. These include assays for cytokines such as interleukin-1β, interferon gamma, and tumor necrosis factor, as well as hormone-related markers like testosterone and thyroid-stimulating hormone receptor antibodies. Additional products measure neurological and reproductive biomarkers, such as neuron-specific enolase and inhibin-B. All kits are designed for laboratory use in diagnosing or monitoring various medical conditions.
The portfolio consists of in vitro diagnostic (IVD) devices classified as Class A under EU regulations, with some products listed in the EU’s eudamed registry. The manufacturer is based in China and adheres to relevant regulatory frameworks for IVD medical devices, including general IVD classifications. No additional regulatory bodies or specific national listings are mentioned beyond eudamed.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Sichuan Orienter Biotechnology Co., Ltd. manufacture?
Sichuan Orienter Biotechnology Co., Ltd. specializes in producing chemiluminescent immunoassay kits. These kits are designed to detect specific biomarkers in clinical samples, such as cytokines (e.g., interleukin-1β, interferon gamma), hormones (e.g., testosterone, thyroid-stimulating hormone receptor antibodies), and other relevant markers (e.g., neuron-specific enolase, inhibin-B). These assays support diagnostic or monitoring purposes in laboratory settings.
Where is Sichuan Orienter Biotechnology Co., Ltd. based?
The company is based in China. Its headquarters and manufacturing operations are located within the country, adhering to local regulatory requirements for in vitro diagnostic (IVD) devices.
Are any of Sichuan Orienter Biotechnology Co., Ltd.’s devices listed in regulatory registries?
Yes, some of the company’s in vitro diagnostic (IVD) devices are listed in the EU’s eudamed registry. This registry tracks IVD medical devices authorized for use within the European Economic Area, ensuring transparency and traceability for regulatory oversight.
How are Sichuan Orienter Biotechnology Co., Ltd.’s devices classified under EU regulations?
The company’s devices fall under the Class A classification for in vitro diagnostics under EU regulations, specifically within the IVD General category. This classification applies to low-risk devices, though individual products may vary in risk level depending on their intended use and potential impact on patient health.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- China
- Address
- No.9, Kangqiang 4th Road, Hi-tech Zone Chengdu, Chengdu, China
- Website
- www.orienterglobal.com
- —
- —
- [email protected]
- Phone
- +86-28-62533858
- PRRC Contact
- Longxian Yang
- EUDAMED SRN
- CN-MF-000003026
- FDA FEI Number
- —
- DUNS Number
- —
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