Medical Device Manufacturer Catalog No.8005

Medical Device Manufacturer Catalog No.8005

OROSOL® can produce medical device – Absorbable Implants & Neurosurgical Fixation Systems.

Item Name: OROSOL® Absorbable Implants & Neurosurgical Fixation Systems.

Brand: OROSOL®

OROSOL® can produce all kinds of medical devices.

If you are interested in this product, please feel free to contact us: RoboticWorkCell@outlook.com

Product Description

Medical Device Manufacturer Catalog No.8005

General View of OROSOL® Manufacturer No.8005:

OROSOL Machinery and Equipment Manufacturing LLP is located in China, with Manufacturer No.8005 a modern R&D and manufacturing facility spanning over 30,000 square meters. The company employs more than 450 professional staff members, including a dedicated R&D team of over 80 engineers and technicians specializing in biomedical materials and absorbable implant technology. The company has established a comprehensive platform for absorbable polyester and modified gelatin material development, with products exported to more than 30 countries and regions worldwide. The company has obtained 100+ intellectual property rights including 10+ invention patents and 60+ utility model and design patents.

Medical Device Product Catalog No.8005:

Product Category Product Name & Model Parameters & Specifications Features & Applications
Absorbable Implants OS-AB-100 Absorbable Cranial Bone Lock Material: Surgical-grade poly-L-lactic acid (PLLA); Complete absorption time: 12-24 months; Available in multiple sizes; Sterile single-use packaging; Designed for cranial bone flap fixation. First domestically produced absorbable cranial bone lock approved by NMPA for neurosurgical internal fixation. Features excellent biocompatibility and biomechanical strength. Eliminates need for secondary removal surgery. Winner of 2019 German iF Design Award and 2020 German Red Dot Award.
Absorbable Implants OS-AB-200 Absorbable Craniomaxillofacial Plate & Screw System Material: Surgical-grade poly-L-lactic acid (PLLA); Plate thickness: 0.6-1.2mm; Screw diameters: 1.5mm, 1.8mm, 2.0mm; Complete absorption: 12-24 months; Sterile packaging; Multiple plate configurations available. Absorbable craniomaxillofacial plate and screw system for neurosurgical and maxillofacial fixation. Provides stable fixation during bone healing and is completely absorbed by the body. Eliminates implant-related complications and secondary surgery.
Cranial Implants OS-PEEK-300 PEEK Cranial Bone Repair Plate Material: PEEK-OPTIMA-LT1 (ASTM F2026 compliant); Customizable thickness: 2-8mm; Patient-specific 3D-printed design; MRI/CT compatible; Non-sterile packaging with sterilization instructions. PEEK cranial bone repair plate for neurosurgical cranial defect reconstruction. Offers excellent mechanical properties and radiolucency for post-operative imaging. Custom-designed for optimal anatomical fit.
Craniomaxillofacial Implants OS-PEEK-400 PEEK Maxillofacial Implant System Material: PEEK-OPTIMA-LT1; Patient-specific 3D-printed design; Available for orbital, zygomatic, and mandibular reconstruction; Sterile single-use packaging; MRI/CT compatible. PEEK maxillofacial implant system for orbital, zygomatic, and mandibular reconstruction. Provides excellent aesthetic and functional outcomes with biocompatible PEEK material. Patient-specific design ensures optimal fit.
Absorbable Implants OS-AB-500 Absorbable Maxillofacial Fixation Implant Material: Surgical-grade poly-L-lactic acid (PLLA); Complete absorption time: 12-24 months; Available in multiple sizes and configurations for maxillofacial applications; Sterile single-use packaging. Absorbable maxillofacial fixation implant for oral and maxillofacial surgery. Provides temporary fixation during bone healing and is completely absorbed by the body. Eliminates secondary removal surgery and associated complications.
Wound Care & Dressings OS-WC-600 Medical Cold Compress Gel Dressing Material: Hydrogel with cooling effect; Available in multiple sizes; Adhesive backing for secure application; Sterile single-use packaging; Provides up to 8 hours of cooling therapy. Medical cold compress gel dressing for post-operative pain relief, swelling reduction, and wound care. Provides continuous cooling therapy for enhanced patient comfort. Suitable for various surgical and trauma applications.
Orthopedic Supports OS-OS-700 Medical External Fixation Splint Material: Medical-grade polymer; Available in multiple sizes for different anatomical sites; Radiolucent design for X-ray compatibility; Breathable and lightweight construction; Reusable with cleaning instructions. Medical external fixation splint for fracture stabilization, post-operative immobilization, and orthopedic support. Provides rigid fixation with patient comfort. Radiolucent design enables imaging without removal.
Wound Care & Dressings OS-SD-800 Scar Management Dressing Material: Medical-grade silicone; Available in multiple sizes; Self-adhesive design; Washable and reusable (up to 28 days); Skin-friendly, hypoallergenic material. Silicone scar management dressing for prevention and treatment of hypertrophic scars and keloids. Provides effective scar reduction with comfortable, discreet wear. Clinically proven for scar management in post-surgical and traumatic wound healing.
Ultrasound Accessories OS-UG-900 Medical Ultrasound Coupling Gel Sterile formulation; Hypoallergenic; Water-soluble; Easy to clean; Available in 250ml and 1000ml bottles; Compatible with all ultrasound systems. Medical ultrasound coupling gel for diagnostic and therapeutic ultrasound procedures. Provides excellent acoustic coupling for clear imaging. Sterile formulation ensures patient safety in invasive procedures.
Wound Care & Dressings OS-EL-1000 Elastic Compression Bandage Material: Cotton/polyester blend with elastic fibers; Available in multiple widths (5cm, 7.5cm, 10cm, 15cm); High elastic recovery; Breathable and skin-friendly; Reusable with washing instructions. Elastic compression bandage for wound dressing fixation, pressure therapy, and edema management. Provides consistent compression for enhanced healing. Suitable for post-operative wound care and sports medicine applications.
ENT Products OS-ENT-1100 Ear, Nose & Throat Hemostatic & Support Products Available configurations: Eustachian tube balloon dilation, sinus stent, nasal packing; Biocompatible materials; Radiopaque markers for imaging; Single-use sterile packaging. ENT hemostatic and support products for ear, nose, and throat applications. Provides effective hemostasis, physical support, and low-dose drug delivery for improved patient outcomes in ENT procedures.

Certificates of OROSOL® Medical Device Manufacturer 8005:

  • ISO 13485:2016 — Medical Devices Quality Management System (Certified)
  • FDA 510(k) Clearance — Absorbable Cranial Bone Lock (Class II)
  • CE Marking (MDR 2017/745/EU) — Compliance with European Medical Device Regulation
  • NMPA Medical Device Registration Certificate (Class III) — China National Medical Products Administration
  • NMPA Medical Device Registration Certificate (Class II) — China National Medical Products Administration
  • GMP Certification — Good Manufacturing Practice for Medical Devices (China NMPA)
  • NMPA Medical Device Master File Registration — Poly-L-lactic Acid for Surgical Implants
  • National High-Tech Enterprise Certification (China)
  • Sichuan Province “Specialized and Sophisticated” SME Certification
  • Red Dot Design Award 2020 — Product Design
  • iF Design Award 2019 — Product Design
  • RoHS Compliant — Restriction of Hazardous Substances Directive (EU)
  • REACH Compliant — Registration, Evaluation, Authorization and Restriction of Chemicals (EU)

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