GUANGZHOU GIOTECH CO. LTD.

Guangzhou Giotech Co. Ltd. produces two main types of medical devices: the SENSICECS PF, which is designed for patient monitoring, and the EMPAPADOR SUPER 60X90, a reusable waterproof protective pad used in healthcare to absorb fluids and support patient hygiene. These devices serve distinct but complementary roles in clinical settings, ensuring patient comfort and safety.

The company is headquartered in China, which is its primary location for manufacturing and operations. While the country of origin does not inherently determine a device’s regulatory classification or approval status, it influences compliance requirements for global markets. For example, devices listed in eudamed must meet EU MDR standards, regardless of manufacturer location.

The company’s devices are listed in the EU’s eudamed registry, which is the official database for medical devices under the EU Medical Device Regulation (MDR). Listing in eudamed is mandatory for Class I devices intended for the European market, ensuring transparency and traceability for healthcare providers and regulators.

Both the SENSICECS PF and EMPAPADOR SUPER 60X90 fall under Class I classification in the EU MDR framework. This classification applies because these devices pose minimal risk to patients and users, requiring only basic safety and performance requirements. Class I devices typically undergo a conformity assessment via internal production quality assurance, but they still must comply with EU MDR obligations like UDI labeling and post-market surveillance.