Strengthening Compliance, Advancing Toward Global Markets

Recently, NEST has officially completed U.S. Food and Drug Administration (FDA) establishment registration and obtained its FDA registration certificate.

This achievement marks that NEST has met the basic regulatory entry requirements of the U.S. market for life science and biopharmaceutical-related products, reflecting its robust capabilities in compliance management, quality control, and international operations, and laying a stronger regulatory foundation for serving global customers.

The FDA is one of the world’s most influential regulatory authorities for medical products and life sciences. FDA establishment registration is a fundamental compliance filing required for companies engaged in the manufacturing, processing, packaging, or holding of regulated products.

What Does FDA Registration Mean for NEST?

FDA registration represents a milestone in NEST’s long-term standardized management practices. It confirms that NEST’s corporate entity has been officially recognized by the FDA and listed in its database, ensuring international traceability.

It also demonstrates that NEST’s quality management system is aligned with international standards, and that its R&D and manufacturing processes comply with global regulatory expectations—significantly enhancing brand credibility in highly regulated markets such as North America and Europe.

What Does This Mean for Customers?

Lower compliance risk: Clear corporate registration status and smoother audit and inspection processes

More stable supply: FDA registration requires continuous compliance investment, supporting product consistency and long-term supply reliability

Easier global expansion: FDA registration is a key advantage in international projects, reducing regulatory communication costs and accelerating global business deployment

Scope of FDA Registration and Product Listing

This FDA registration and product listing cover multiple core NEST product categories, including but not limited to:

Laboratory and clinical consumables:

Cell culture flasks, sterile sample containers, centrifugation-related products

Cell and microbiology-related products:

Media preparation, transportation, and storage products

Medical and drug delivery components:

Syringe pistons, sterile swabs and absorbent tips, and nasal drug delivery devices

Compliance as a Long-Term Commitment

Obtaining FDA registration is a significant milestone in NEST’s globalization journey—but not the endpoint.

Moving forward, NEST will continue to uphold regulatory compliance as a fundamental principle and product quality as its core focus, delivering stable, reliable, and long-term trusted consumables and solutions for global life science and biopharmaceutical customers.

Compliance is NEST’s most basic—and most important—commitment to its customers.