Nanjing Hecho Technology Secures Medical Device Registration for Two Laser Fiber Products

NANJING, China, June 23, 2026 — Nanjing Hecho Technology Co., Ltd. today announced that its independently developed "Medical Laser Fiber" and "Single-Use Sterile Laser Fiber" have received Class II medical device registration certificates from the Jiangsu Provincial Drug Administration.

The registrations mark the company‘s official entry into the ranks of compliant suppliers of medical laser fibers in China, representing a substantive step forward in Hecho’s strategic expansion into the medical device sector.

A Hard-Earned Certification

Obtaining a Class II medical device registration certificate is a lengthy and rigorous process.

Under China‘s Regulations on the Supervision and Administration of Medical Devices, no Class II medical device may be manufactured, sold, or used without a registration certificate. The approval process itself encompasses dozens of stages—including product technical requirements development, registration testing, biological evaluation, shelf-life validation, and sterilization process research—each governed by explicit national standards and subject to review by authoritative bodies.

This demands that a company possess integrated capabilities across materials science, optics, microbiology, and quality management. A shortfall in any single area can result in the registration application being returned or rejected.

Hecho initiated its medical fiber product registration work in 2021. Over the course of nearly five years, the company completed product development, quality system establishment, registration testing, clinical evaluation (where applicable), and regulatory response submissions, ultimately securing two registration certificates in 2026.

This achievement is not the result of a sudden breakthrough, but of sustained investment, repeated refinement, and the successful navigation of multiple regulatory hurdles.

What This Means for the Company

The two registrations represent a pivotal moment in Hecho‘s transition from an industrial optical component supplier to a compliant medical device manufacturer.

Prior to this, the company had深耕 the specialty optical fiber sector for nearly two decades, building a strong technical foundation and customer reputation in industrial automation and scientific research optics. However, the medical field imposes a higher barrier to entry—technical competence alone is a prerequisite; regulatory compliance is the ticket to entry.

That ticket has now been secured. The company is formally qualified to manufacture and commercially distribute medical laser fibers in compliance with regulations, enabling batch production, participation in hospital tenders, and compliant supply to distributors and equipment manufacturers.

This marks a transition from “capable of making” to “authorized to sell.” The market opportunity for the company‘s products now formally extends from industrial and research applications into the medical and healthcare sector—a market of significantly greater scale with higher barriers to entry.

What This Means for Customers

For purchasers in the medical device industry, a supplier’s regulatory certification is the primary consideration in any procurement decision.

The registrations send three clear signals to customers:

Compliant procurement is now possible. In hospital tenders, distributor product selection, and equipment配套 procurement, registration certificates are a hard requirement for qualification review. Hecho is now officially on the compliant supplier list—customers can legally and compliantly source and use Hecho‘s products.

Reliable supply is guaranteed. Registration approval means the products have reached a mature production stage. They are no longer laboratory samples or trial products. The company has the capacity for consistent, volume production and delivers finished products that have undergone complete registration testing.

Product quality is endorsed. The safety and efficacy of the products have been validated through the rigorous review of the Jiangsu Provincial Drug Administration. This is not a self-declaration by the company, but an official, authoritative endorsement.

In short: customers can select with confidence and use with compliance.

About the Products

Both approved products fall under the medical laser fiber category, used to connect laser therapy devices and deliver laser energy to human tissue. They are commonly used instruments in laser surgeries across urology, dermatology, and otolaryngology.

The "Medical Laser Fiber" is a standard-configuration product suitable for a variety of laser surgery scenarios. The "Single-Use Sterile Laser Fiber" features sterile packaging, eliminating the need for on-site sterilization before clinical use—ready to use straight out of the package, effectively reducing the risk of cross-infection and meeting clinical demands for greater convenience and safety.

With the approval of both products, Hecho can now offer differentiated options for different clinical scenarios, establishing an initial product portfolio in the medical laser fiber segment.

Looking Ahead

The two registration certificates are a milestone—and a starting point.

Hecho will continue to advance the R&D and iteration of its medical laser fiber product series, while accelerating registration applications for new products such as single-use endoscopic fibers. The company‘s commitment to the medical sector will not stop here.

From industrial to medical applications, from R&D to regulatory approval, from products to comprehensive solutions—Hecho is dedicated to becoming a trusted optical transmission solutions provider in clinical settings, enabling light to create greater value in healthcare.

About Nanjing Hecho Technology Co., Ltd.

Founded in 2005, Nanjing Hecho Technology Co., Ltd. is a leading provider of specialty optical fiber transmission solutions in China. The company‘s product portfolio includes plastic optical fibers, glass fibers, quartz fibers, fiber bundles, light guides, cold light sources, and sensors, widely used in industrial automation, medical devices, and scientific research optics. Hecho offers full delivery capabilities ranging from standard products to custom non-standard solutions.

For more information, visit: www.gohecho.cn

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