Baird Medical obtains Class C device registrations in Vietnam and preliminary approval in Egypt
Baird Medical Investment Holdings Limited announced that it received Class C medical device registration certificates for several microwave ablation products in Vietnam. The company also reported that the Egyptian Drug Authority issued a preliminary approval for its BD‑GT Microwave Ablation System and accessories. CEO Haimei Wu said the approvals are key steps for expanding the technology beyond the United States and China. No financial guidance or sales timetable was provided.
Why it matters
The new Vietnamese registrations allow the company to market its ablation needles and generators in that market, potentially increasing future sales. The Egyptian preliminary approval moves the product closer to full registration, but commercial sales will depend on final approval, which has not yet been set.
Key facts
- 1Class C medical device registration certificates were issued in Vietnam for the J-series and G-series microwave ablation needles, as well as the MTI‑5AT and MTI‑5ET generators. investing.com
- 2The Vietnamese registrations follow an earlier product registration that the company obtained in Vietnam in January 2026. finance.yahoo.com
- 3The Egyptian Drug Authority granted a preliminary approval for the BD‑GT Microwave Ablation System and related accessories in January 2026. investing.com
- 4The Egyptian preliminary approval is an intermediate step before final registration of the system’s sterile accessories. finance.yahoo.com
- 5Baird Medical holds FDA 510(k) clearance for its microwave ablation technology since November 2023. investing.com
- 6CEO Haimei Wu said the regulatory milestones are important for expanding the company’s presence in strategic markets beyond the U.S. and PRC. investing.com
Summary written by AlphAI AI Desk from 2 of 2 sources. Not investment advice. Figures are as stated by the linked sources.