Medical Device Manufacturer Catalog No.8011

Medical Device Manufacturer Catalog No.8011

OROSOL® can produce medical device – Minimally Invasive Surgical Instruments & Accessories.

Item Name: OROSOL® Minimally Invasive Surgical Instruments & Accessories.

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.8011

General View of OROSOL® Manufacturer No.8011:

OROSOL Machinery and Equipment Manufacturing LLP is located in China, with Manufacturer No.8011 a modern manufacturing facility spanning over 30,000 square meters. The company employs more than 100 professional staff members, including a dedicated R&D team specializing in minimally invasive surgical instruments. The company is a National High-Tech Enterprise and Anhui Province “Specialized and Sophisticated” Enterprise. It has been designated as an Anhui Provincial Green Factory and Anhui Provincial Innovative Pilot Enterprise. The company has invested 18.1 million RMB in R&D over the past three years, holding 36 invention patents and 42 utility model patents, with 41 provincial-level scientific and technological achievements registered. The company has established a provincial-level Industrial Design Center for Surgical Instruments. The company serves as the leading drafter of national pharmaceutical industry standards YY/T 1710-2020 “Disposable Abdominal Puncture Device” and YY/T 1980-2025 “Disposable Sterile Wound Protector,” and is currently leading the drafting of the industry standard for “Disposable Microfascial Closure Devices”. The company’s manufacturing facilities include 3,300㎡ of clean production areas compliant with Class II/III medical device production requirements, including a 350㎡ Class 10,000 clean production area. The company has also established a 135㎡ Class 10,000 local Class 100 microbiology laboratory, as well as physical/chemical/precision measurement laboratories, providing full-process testing capabilities from raw materials to finished products. The company has obtained ISO 13485, ISO 14001, and ISO 45001 certifications, with selected products holding EU CE marking certification. The company’s flagship product, the laparoscopic puncture device, holds a 5.8% domestic market share and has been successfully awarded in multiple provincial and inter-provincial centralized volume-based procurement programs for medical consumables.

Medical Device Product Catalog No.8011:

Product Category Product Name & Model Parameters & Specifications Features & Applications
Minimally Invasive Surgical Instruments OS-PC-100 Disposable Abdominal Puncture Device (Laparoscopic Puncture Device) Available models: FQ型 (abdominal), XQ型 (thoracic); Specifications: 3mm×35mm, 5.5mm×80mm, 10.5mm×80mm, 12mm×80mm, 15mm×80mm, 3mm×45mm, 5.5mm×100mm, 10.5mm×100mm, 12mm×100mm, 15mm×100mm, 3mm×65mm, 5.5mm×110mm, 10.5mm×110mm, 12mm×110mm, 15mm×110mm, 3mm×80mm, 5.5mm×150mm, 10.5mm×150mm, 12mm×150mm, 15mm×150mm, 3mm×100mm, 5.5mm×180mm; Material: ABS (Taiwan) for puncture rod, PC-2858 (Bayer) for puncture tip and annular cannula; Sterile; CE certified. Disposable puncture device for establishing instrument access channels during laparoscopic or thoracoscopic surgery. The product complies with YY/T 1710-2020 national standard. Available in abdominal and thoracic configurations for diverse surgical applications.
Wound Protection Devices OS-WP-200 Incision Skin Tissue Retractor & Expander Material: Medical-grade film and silicone options; Multiple sizes available; Designed for wound edge protection and tissue expansion; Sterile; CE certified. Wound protector and retractor for surgical incisions. Protects wound edges from contamination and reduces tissue trauma during surgery. Available in film and silicone variants to suit different surgical requirements.
Drainage & Fixation Devices OS-DF-300 Fixed Drainage Tube Device Various sizes for different drainage tube diameters; Secure fixation mechanism; Sterile; CE certified. Fixation device for securing drainage tubes in place, preventing accidental displacement and reducing the risk of infection and tissue trauma. Suitable for various drainage applications across multiple surgical specialties.
Minimally Invasive Surgical Instruments OS-MI-400 Non-Inflatable Cavity-Assisted Instrument System Designed for non-inflatable cavity-assisted surgery; Complete system with multiple interchangeable components; Sterile packaging. Advanced instrument system for non-inflatable cavity-assisted surgical procedures. Enables surgeons to perform minimally invasive procedures without gas inflation, reducing the risk of associated complications.
ENT Instruments OS-ENT-500 Otorhinolaryngology Dilator Model: KZQ-A; Specifications: 160mm×30mm, 160mm×30mm-A, 160mm×30mm-B, 160mm×30mm-C, 160mm×30mm-D, 160mm×30mm-E; Non-sterile, reusable (sterilization by user); Non-endoscopic use; Classification: 02-11-03. ENT dilator for tissue expansion in ear, nose, and throat procedures. Non-sterile, reusable instrument for dilation and exposure in otolaryngology surgeries. Appropriate for both adult and pediatric applications.
Surgical Instruments OS-SR-600 Surgical Retractor Model: SSLG-I and SSLG-II; Specifications: 147mm×12.5mm×5.5mm-A, 167mm×25mm×1.2mm-A; Non-sterile, reusable (sterilization by user); Non-endoscopic use; Classification: 02-08-01. Surgical retractor for tissue retraction and exposure during open surgical procedures. Designed for hooking and retracting tissues to improve surgical field visibility.
Surgical Instruments OS-DS-700 Dissector Model: BLQ-I and BLQ-II; Specifications: 218mm×98.5mm×9.5mm×31mm×12mm, 218mm×98.5mm×9.5mm×31mm×12mm-A; Non-sterile, reusable (sterilization by user); Non-endoscopic use; Classification: 02-10-01. Dissector for tissue dissection and separation during surgical procedures. Used for separating mucous membranes and tissues to create surgical access.
Surgical Instruments OS-TR-800 Tissue Retractor Model: LG type; Specifications: A-L1, A-L2, A-L3, B-L5, B-L6, B-L7, B-L8, C-L5, C-L6, C-L7, C-L8, D-L9, D-L10, E-L11, E-L12, E-L13, F-L1, F-L2, F-L3, G-L1, G-L2, G-L3, H-L1, H-L2, H-L3; Non-sterile, reusable; Non-endoscopic use; Classification: 02-08-01. Tissue retractor for hooking and retracting tissues during open surgical procedures. Available in multiple specifications for various surgical applications.
Surgical Instruments OS-WR-900 Wound Retractor Model: QKQ and QKQ-A; Specifications: multiple sizes; Non-sterile, reusable (sterilization by user); Non-endoscopic use; Classification: 02-11-01. Wound retractor for tissue retraction in surgical procedures. Used in conjunction with retractor hooks for optimal surgical field exposure. Features adjustable locking mechanism for precise positioning.
Surgical Instruments OS-BP-1000 Micro Skin Biopsy Punch Model: Flat mouth (BN-MCR-1) and Notched mouth (BN-MCR-2); Specifications: Φ1mm, Φ1.5mm, Φ2mm, Φ2.5mm, Φ3mm, Φ3.5mm, Φ4mm; Material: Medical 9Cr18 stainless steel and medical-grade ABS resin; Non-sterile, reusable (sterilization by user); Non-CNS/non-circulatory contact; Non-endoscopic use; Classification: 02-12-02. Micro skin biopsy punch for tissue puncture and access establishment. Used for skin biopsy and dermatological procedures. Available in multiple sizes for sampling different lesion sizes.
Hospital Supplies OS-TO-1100 Tourniquet Model: ZXD type; 32 specifications based on long axis length and elastic band length; Material: Silicone; Non-sterile; Classification: 14-04-03. Tourniquet for brief venous occlusion during IV infusion or blood draw procedures. Silicone construction provides safe, reliable venous compression with minimal patient discomfort.
Hospital Supplies OS-LP-1200 Limb Pressure Sleeve Registration: Class I medical device; Multiple sizes for upper and lower limb applications. Limb pressure sleeve for compression therapy and pressure application. Used for various therapeutic and diagnostic applications requiring controlled pressure on extremities.
Hospital Supplies OS-SG-1300 Medical Splash-Proof Isolation Shield Various sizes; Clear material for visibility; Designed for surgical and procedural use. Medical splash-proof isolation shield for protection against fluid splashes during surgical and medical procedures. Provides additional barrier protection for healthcare workers.

Certificates of OROSOL® Medical Device Manufacturer 8011:

  • ISO 13485:2016 — Medical Devices Quality Management System (Certified)
  • ISO 14001:2015 — Environmental Management System (Certified)
  • ISO 45001:2018 — Occupational Health and Safety Management System (Certified)
  • CE Marking — Selected products certified
  • NMPA Medical Device Registration Certificate (Class II/III) — Multiple registrations
  • Class I Medical Device Filing — Multiple product filings
  • GMP Certification — Good Manufacturing Practice for Medical Devices (China NMPA)
  • National High-Tech Enterprise Certification (China)
  • Anhui Province “Specialized and Sophisticated” Enterprise
  • Anhui Provincial Green Factory Certification
  • Anhui Provincial Innovative Pilot Enterprise
  • Anhui Provincial Industrial Design Center — Surgical Instruments
  • Industry Standard Leading Drafter — YY/T 1710-2020, YY/T 1980-2025
  • ISO 9001:2015 — Quality Management System (Certified)
  • RoHS Compliant — Restriction of Hazardous Substances Directive (EU)
  • REACH Compliant — Registration, Evaluation, Authorization and Restriction of Chemicals (EU)

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