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

PRODUCT CATEGORIES

Disposable Flexible Ureteroscope

 (15)

Disposable Flexible Endoscope

 (15)

Ureteral Access Sheath

 (15)

Zebra Guide Wire

 (15)

Percutaneous Nephrostomy Kit

 (15)

Stone Retrieval Basket

 (12)

Ureteral Stent

 (10)

Hydrophilic Guide Wire

 (15)

Ureteric Stents

 (10)

Ureteral Balloon

 (10)

Biliary Drainage Catheter

 (15)

Fallopian Tube Catheterization Set

 (10)

Percutaneous Transhepatic Biliary Drainage

 (10)

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) upgrade underway (anticipated Q1 2025) with TÜV SÜD as notified body
  • 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 Q2 2025 submission

Certification

Hunan Endovascular Device Co., Ltd. Certifications
Standard: ISO-13485
Hunan Endovascular Device Co., Ltd. Certifications
Standard: lzin Distribusi Alat Kesehatan
Number: 20805520377
Expiry Date: 2030-04-28
Scope/Range: Ureteral Access Sheath
Issued By: PEMERINTAH REPUBLIK INDONESIA
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