Tongxin Home Care Industry (Shenzhen) Co., Limited

Tongxin Home Care Industry (Shenzhen) Co., Limited manufactures reusable endotracheal tube holders, which are used to secure airway tubes in clinical environments, and nasopharyngeal medicine administration kits with atomizers, designed for delivering inhaled medications. These devices are developed to support respiratory care and medication delivery in healthcare settings.

The company is based in the United States. This location is relevant for regulatory compliance and distribution, as it aligns with the FDA’s jurisdiction over medical devices marketed in the US.

The company’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency in the supply chain, allowing healthcare providers and regulators to verify device details, such as manufacturer information and classification.

All devices produced by Tongxin Home Care Industry (Shenzhen) Co., Limited fall under Class I regulatory classification. This classification applies to devices posing minimal risk to patients, such as reusable endotracheal tube holders and nasopharyngeal atomizers, which typically require less stringent premarket review compared to higher-risk devices.