FAQ
Frequently asked questions.
Clear answers about the Nexusuro Prostate Dilation System: brand, technology, procurement, and compliance.
Brand & manufacturing
What is Nexusuro?
Nexusuro is an international urology brand focused on global BPH MIST promotion and distribution. Nexusuro is the brand and marketing partner — it does not manufacture products.
Who manufactures the product?
Manufactured in partnership with Hangzhou Hongyuan Medical Co., Ltd., which holds NMPA registration and ISO 13485 certification from its GMP-compliant facility in Hangzhou, China.
Why HONGYUAN and Nexusuro?
HONGYUAN (弘圆) is the manufacturer's brand for China. Nexusuro is the international brand for overseas markets. Same product series, different brand by market — standard practice for Chinese device manufacturers.
Is Nexusuro the manufacturer?
No. Nexusuro is the international brand and marketing partner. The manufacturer is Hangzhou Hongyuan Medical Co., Ltd.
Who holds NMPA registration?
The manufacturer, Hangzhou Hongyuan Medical Co., Ltd. Nexusuro does not hold NMPA registration.
Product & technology
How does the system work?
A transurethral balloon catheter performs controlled mechanical dilation of the prostatic urethra, relieving BPH obstruction. No laser, RF, or steam — purely mechanical. Full mechanism.
Does it require general anesthesia?
Most patients are treated under local anesthesia with sedation. The specific approach is determined by the urologist per case.
How does it compare to UroLift and Rezūm?
vs. UroLift: no permanent implant. vs. Rezūm: no thermal energy. Full MIST comparison.
Who is a candidate?
Men with moderate-to-severe BPH/LUTS who haven't responded to medication, who want to avoid TURP or permanent implants, and who are assessed as suitable by a urologist.
How long is the learning curve?
Experienced endoscopists become independent after 1-2 training sessions. The standardized three-step protocol eliminates the need for DRE, significantly reducing the learning curve compared to the traditional eight-step method requiring 3-6 months of experience. Training via physician inquiry.
Procurement & partnerships
How do I procure the product?
Contact us to discuss equipment, consumables, and procurement. We'll connect you with the right channel.
Is international distribution available?
Yes. Partners with urology channels and local regulatory capability: international page or partners page.
Academic or research collaboration?
Yes. White paper page or contact page.
How do I get the full white paper?
Submit a request via the white paper page. Response within 3-5 business days.
Compliance & quality
What certifications does the manufacturer hold?
NMPA registration (China), ISO 13485 quality management system, medical device production license, and GMP-compliant facilities in Hangzhou, China.
Is the device ISO 13485 certified?
Yes, the manufacturing partner holds ISO 13485 certification. For territory-specific documents: contact page.
How do I report a quality concern?
Via the contact page. Concerns trigger a standardized response: root cause assessment, corrective actions, and regulatory reporting as required.
Didn't find your answer?
Submit your question — we respond within 1-2 business days.
FAQ answers reflect currently available product and partnership information. Indications, regulatory status, and commercial terms may vary by territory.