On April 28, 2019, our new product "Reusable Operation Form" was registered by the Guangxi Zhuang Autonomous Region Drug Administration Bureau and approved for domestic listing. Device registration certificate!
Tecbods reusable surgical sheet includes three products: surgical hole towel, surgical sheet and instrument sheet, which are woven from medical long-fiber polyester fiber functional materials and carbon fiber conductive yarn. Comply with the performance requirements of Chinas YY / T 0506.2-2016 surgical gown. Compared with cotton surgical sheets, it has the following functions:
1. It has the characteristics of "self-cleaning" of splash-proof, oil-proof and anti-fouling;
2. It has a two-way barrier function that prevents penetration and bacteria, prevents the migration of microorganisms, and reduces the risk of infection at the surgical site of the patient;
3. Permanent anti-static effect, which can effectively avoid the adsorption of tiny dust particles and reduce interference to precision electronic equipment;
4. No flocculation, reduce the infection of surgical site (SSI) caused by insoluble fiber particles, and reduce the pollution of cotton dust in clean ventilation pipes;
5. Reusable up to 105 times, high cost performance, economic and environmental protection;
6. Better thermal insulation effect, reduce the incidence of hypothermia in patients;
Product drawings are for reference only, the actual product shall prevail
What is a soft device?
The new version of the "Category of Medical Device Classification" implemented on August 1, 2018 has included reusable surgical gowns and surgical drapes in the management of Class II medical devices, followed by the "Basic Standards and Management Specifications of Medical Disinfection Supply Center (Trial)" , First proposed the concept of "soft instruments":
Surgical gowns, surgical covers, etc. that can block water, bacteria, and breath, and wearable and foldable infection control devices that meet the classification catalog of surgical instruments with bidirectional protection.
Therefore, textile medical gowns and surgical drapes without medical device registration certificates used by domestic medical institutions will face the risk of supervision and inspection by the use of medical device products without registration certificates.
Tecbod "soft equipment" products are ready
On January 25, 2018, our company received the registration certificate of the second-class medical device for reuse of surgical gowns, and on April 28, 2019, we obtained the registration certificate of the second-class medical device for reusable surgical singles. So far, our company is the only medical device manufacturer with complete soft device products in China, and will provide legal, compliant and high-quality products and services for more medical institutions, device operation companies and third-party decontamination centers!