Hunan Endovascular Device Co., Ltd.
Verified Supplier
2 Years
hunan, changsha
Since 2011
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Zebra Guide Wire
Ureteral Access Sheath
Stone Retrieval Basket
Single Use Flexible Ureteroscope
Hydrophilic Guide Wire
Ureteral Stent
Ureteral Balloon
Percutaneous Nephrostomy Kit
Biliary Drainage Catheter
Disposable Flexible Endoscope
Single Use Flexible Cystoscope
Ureteric Stents
Percutaneous Endoscopic Gastrostomy PEG Kit
Ileus Tube
Percutaneous Transhepatic Biliary Drainage
Fallopian Tube Catheterization Set
Company profile
Quality control
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Supplier Homepage > Products

PRODUCT CATEGORIES

Zebra Guide Wire

 (15)

Ureteral Access Sheath

 (15)

Stone Retrieval Basket

 (6)

Single Use Flexible Ureteroscope

 (14)

Hydrophilic Guide Wire

 (7)

Ureteral Stent

 (7)

Ureteral Balloon

 (1)

Percutaneous Nephrostomy Kit

 (14)

Biliary Drainage Catheter

 (11)

Disposable Flexible Endoscope

 (15)

Single Use Flexible Cystoscope

 (1)

Ureteric Stents

 (10)

Percutaneous Endoscopic Gastrostomy PEG Kit

 (2)

Ileus Tube

 (7)

Percutaneous Transhepatic Biliary Drainage

 (1)

Fallopian Tube Catheterization Set

 (1)

Why Can We Always Ensure Excellent Quality

Quality Control

Quality Assurance & Regulatory Compliance
Manufacturing Excellence
  • Full vertical integration ensures end-to-end quality control from raw materials to finished devices
  • ISO 13485:2016 certified by TÜV SÜD (quality management system)
  • CE-MDR (2017/745)
  • 24 products approved under China NMPA medical device registration
Clinical Validation
  • 15+ years of specialized nephrostomy device manufacturing expertise
  • 12 clinical studies demonstrating safety and efficacy (data available upon request)
  • Documented 98.2% first-attempt success rate across 2,300+ PCNL procedures
Continuous Quality Commitment
  • Quarterly ISO 10993 biocompatibility testing protocol
  • 100% real-time needle sharpness verification during production
  • Dedicated MDR transition team implementing enhanced post-market surveillance
Competitive Advantages
  • Single-source manufacturing ensures supply chain security
  • Dual regulatory compliance (24 NMPA approvals + ISO 13485)
  • Active FDA 510(k) preparation for Q4 2026 submissionHunan Endovascular Device Co., Ltd.

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