Medical Device Category: Class Medical Devices
Whether it is a medical device: Yes
Origin: Dezhou City, Shandong Province
Medical device registration certificate number or filing certificate number: Lude Machinery No. 20210092
Medical device name: Medical hand external fixator
model: SGD-I001
Specification: SGD-I001
structure and composition: It is made of polymer materials, fabrics, leather, and metal materials. It is worn or placed on the surface of the body to limit the movement of the body to maintain the stability of the body. Passive products.
Registrant or filer information: Tangpai Medical Co., Ltd.
manufacturer: Tangpai Medical Co., Ltd.
Production license or record certificate number: Lude Food and Drug Supervision Equipment Production No. 20200021
unit of measurement: piece
Product technical requirement number: Lude Machinery No. 20210092
taboo: 1. Those with bleeding, ulceration, or unknown skin mass are forbidden; 2. Those with allergies are forbidden to use; 3. Do not exercise vigorously after wearing;
storage conditions: Please keep it in a dry, ventilated, non-corrosive gas environment, away from fire and flammable materials.