TANGSHAN ZHENGTONG EXHIBITION CO., LTD.

Tangshan Zheng Tong Exhibition Co., Ltd. specializes in dental devices, including single-use items like dental impression trays and disposable injection cannulas for dental materials. They also produce ceramic-based materials for dental appliance fabrication, polishing systems (such as flexible polishing discs and diamond-impregnated systems), dental matrices, forceps for dental dam clamps, and dentifrice. These products are designed for use in dental procedures and restorative treatments.

The company is based in China. While its location determines its regulatory jurisdiction for manufacturing and compliance, the devices themselves are classified under EU regulations when listed in systems like EUDAMED. The company’s products are recorded in EUDAMED, indicating they may be intended for or marketed within the European Union, though regulatory approval is granted per device, not the company.

Devices from Tangshan Zheng Tong Exhibition Co., Ltd. are listed in the EUDAMED database. This registry is used for medical devices within the European Union to track authorized products under the Medical Device Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR). Since all listed devices fall under Class I classification, they require less stringent pre-market scrutiny but still must comply with EU regulatory requirements to be recorded in EUDAMED.

All devices produced by Tangshan Zheng Tong Exhibition Co., Ltd. fall under Class I regulatory classification. This classification applies to low-risk devices like single-use dental tools, polishing systems, and certain dental materials. Class I devices typically require basic compliance with general safety and performance requirements but do not undergo the same rigorous clinical evaluation as higher-risk categories.