Fourth in the world! First in ! NEST reusable pen injector approved US FDA 510 (k)!-무석내사생명과학기술주식유한회사

In June 2024, the pen injector independently developed and produced by NEST Biotechnology Co., Ltd. (hereinafter referred to as NEST) won the US Food and Drug Administration (FDA) 510 (k) Letter!

The submission can be checked on the official website! The link is as follows: (or click ‘read original’ for direct access)

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm

This marks that NEST has the independent and controllable integrated service capability of the whole industry chain, and can provide ultra-high quality customized services!

American FDA-high standard, global trust, quality assurance

Founded in 1906, the FDA (Food and Drug Administration) was authorized by the United States Congress and is recognized as one of the largest food and drug regulatory agencies in the world. At present, the products of food, drugs, cosmetics and medical devices certified by the US FDA are globally recognized as effective and safe products, and are the world's highest standard proof of product quality and effect.

As an innovative brand independently developed independently, NEST reusable pen injector is the fourth product in this field and the first product in to obtain FDA certification! Global trust! Quality assurance!

In the field of medical devices, the US FDA certification plays an extremely important role:

1. Objective review: The US FDA supervises and reviews the medical devices on the market, and the non-compliant products may be withdrawn or punished. Getting US FDA certification requires a large number of product designs including clinical assessment, risk management documentation, and registration materials, which are objective, scientific, and eviewed by the US FDA with high standard. This rigorous review ensures that the safety and effectiveness of medical devices are fully validated and also reduces the risk of patient use.

2. International recognition and market access: FDA certification enjoys an excellent reputation around the world, and many countries and regions regard FDA certification as an important symbol of the safety and quality of medical devices. Many hospitals, medical institutions and physicians also prefer to choose US FDA certified products when choosing devices. Medical device manufacturers recognized by the US FDA will help build consumer trust in their products, and will also bring broader market access and greater sales opportunities.

3. Continuous supervision: Obtaining the US FDA certification is not the end point. After the manufacturer sells the medical devices on the market, the US FDA will supervise the products on the market to ensure the continuous compliance of the medical devices in the long-term use.

Authoritative certification-NEST has achieved a milestone leap in the field of pharmaceutical packaging materials

In the past 15 years, NEST has been deeply engaged in the life science industry and continuously expanded its industrial line. From the initial laboratory consumables to medical devices, new pharmaceutical packaging consumables, biological database solutions, biological process accessories, etc., it has always adhered to independent innovation as the main driver of vigorous development.

NEST pen injector is an injection device that combines the liquid and the syringe. The liquid is placed in the form of the pen. When used, it does not need to extract the liquid each time, just pull off the pen cap and adjust the button to the pre-set dose, and the relevant liquid injection can be carried out. NEST pen injectors are currently divided into two types: disposable pen injectors and reusable pen injectors.

In the future, NEST will keep innovative R&D as its strategic core and continue its development in the life sciences field. We will support the customers with integrated services of higher variety and effectiveness.

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