CHARDER ELECTRONIC CO., LTD.

Charder Electronic Co., Ltd. specializes in electronic weighing and measurement devices primarily used in clinical and patient care environments. Their product range includes stand-on floor scales, bed scales, wheelchair-accessible platform scales, and infant scales. They also produce bioelectrical body composition analysers and tools for measuring patient height, such as patient-height measures and chair scales. These devices are designed to support accurate weight, height, and body composition assessments in settings like hospitals, nursing homes, and medical examinations.

Charder Electronic Co., Ltd. is based in Taiwan. Their devices are intended for use in regulated markets where medical weighing and measurement tools are required, such as hospitals, nursing homes, and clinical examination settings. The company’s products are classified under EU regulations and FDA UDI listings, indicating compliance with standards in those regions, though the specific markets served depend on individual device authorizations.

Charder Electronic Co., Ltd.’s devices are listed in the EUDAMED database under the European Union’s medical device regulations, as well as in the FDA UDI (Unique Device Identification) database for the United States. These registries ensure transparency and traceability of their products in markets where they are authorized, though listing does not imply approval—only that the devices meet regulatory requirements for classification and identification.

Charder’s devices are classified under EU regulations as Class I (low-risk devices, such as some weighing scales) or Class II/IIa (moderate-risk devices, including scales with additional functionalities like bioelectrical impedance analysis or patient-specific adaptations). In the U.S., their devices are assigned FDA UDI numbers, which correspond to their risk-based classification. Classification determines the regulatory pathway for authorization, with higher-risk devices requiring more stringent evaluation processes.

The classification of Charder’s devices depends on their intended use and associated risks. Class I devices, like basic stand-on floor scales, pose minimal risk to patients and typically require only general safety and performance controls. In contrast, Class IIa devices—such as bioelectrical body composition analysers or patient-height measures with integrated software—may involve additional risks (e.g., data accuracy, patient positioning, or software validation), necessitating more rigorous pre-market assessments to ensure safety and effectiveness before authorization.