Neudebri 3.1 expert training kit

The Neudebri® 3.1 is classified in reference to the European Union Medical Device Regulation (EU MDR 2017/745) as a Class I reusable surgical instrument, intended for sharp debridement and callus removal in wound management.

The reference regulatory authority for this classification is the European Union – Notified Body under MDR 2017/745.

The product’s safety, performance, and labeling requirements are aligned with the ISO 13485:2016 Quality Management System and ISO 14971:2019 Risk Management standards.

The Neudebri® Debridement surgical Kit is available in three variants, each specifically designed for use by nurses and clinicians, specialized foot care professionals, and home or family caregivers.

Neudebri® 3.1 — Precision in Your Hands

Device Description and Specifications

Intended Use:
Neudebri® 3.1 is a multifunctional surgical-grade instrument designed for sharp debridement in wound care. It efficiently removes non-viable tissues, wound dressing residues, and calluses, ensuring a clean wound bed for optimal healing.

Design and Functionality:
This compact three-part device combines multiple clinical functions into one ergonomic tool.

• Primary Function: Sharp debridement of necrotic or hyperkeratotic tissues.
  

• Secondary Functions: Serves as a vascular clamp and can be used for suture removal with precision and control.
  

• Ergonomic Design: Built for stability and maneuverability in delicate or complex wound beds.
  

• Material: Surgical-grade stainless steel (or specify if coated/treated).
  

• Sterilization Compatibility: Fully autoclavable and reusable.

Performance Highlights:

• Handles coiled wound edges, necrotic slough, and hard-to-reach tissue pockets with ease.
  

• Enables efficient, controlled, and minimally traumatic tissue removal.
  

• Reduces instrument clutter by integrating three essential wound-care functions in one device.
  

• Designed to enhance both speed and precision in clinical debridement procedures.
  

Clinical Value Statement:
Barriers to wound healing—like coiled edges or stubborn necrosis—often challenge even skilled practitioners. With Neudebri® 3.1, these become manageable. The tool’s smart design brings efficiency, precision, and versatility to modern wound care practice, supporting faster wound bed preparation and improved patient outcomes.