Medical Device Manufacturer Catalog No.8012

Product Description

Medical Device Manufacturer Catalog No.8012

General View of OROSOL^® Manufacturer No.8012:

OROSOL Machinery and Equipment Manufacturing LLP is located in China, with Manufacturer No.8012 a modern manufacturing facility spanning over 60,000 square meters. The company employs more than 1,000 professional staff members, including a dedicated R&D team of over 180 engineers and technicians specializing in optoelectronic intelligent identification technology. The company is a National High-Tech Enterprise and National Manufacturing Single Champion Enterprise. Annual R&D expenditure averages approximately RMB 150 million (USD 22.6M), accounting for about 6.5% of annual operating revenue. By 2025, the company has accumulated nearly 800 authorized patents [citation:3]. The company has twice been awarded the National Science and Technology Progress Award and has presided over or participated in the formulation of 12 national and industry standards [citation:3]. Products are exported to over 130 countries and regions worldwide [citation:3].

Medical Device Product Catalog No.8012:

Dental CBCT

Product Name & Model	Parameters & Specifications	Features & Applications
OS-mDX-15Pro Series Dental CBCT (Oral Imaging Intelligent Agent – Meyer Image Engine)	1. Product name: Oral and maxillofacial cone beam computed tomography device; 2. Registration: NMPA approval No. 20253060862; 3. Manufacturer: Hefei Meyer Optoelectronic Technology Inc.; 4. Functions: Cone beam CT, panoramic radiography, and cephalometric radiography (optional); 5. Applications: Oral and maxillofacial X-ray imaging diagnosis; 6. Models: mDX-15Pro-B50, B50F, B50S; mDX-15Pro-Y30, Y30F, Y30S, Y30K, Y30L; mDX-15Pro-K10, K10S.	1. Intelligent dental CBCT system with panoramic and optional cephalometric functions. 2. Provides high-quality 3D imaging for oral and maxillofacial diagnosis. 3. Available in multiple configurations to suit different clinical needs. 4. NMPA-registered medical device for reliable clinical use.
OS-Dental CBCT (Oral Imaging Intelligent Agent – Meyer Qihang)	1. Product name: Oral and maxillofacial cone beam computed tomography device; 2. Functions: Cone beam CT, panoramic radiography, cephalometric radiography, and dental radiography; 3. Applications: Oral and maxillofacial X-ray imaging diagnosis; 4. Manufacturer: Hefei Meyer Optoelectronic Technology Inc.	1. Affordable dental CBCT system with comprehensive imaging functions. 2. Supports CT, panoramic, cephalometric, and dental X-ray modes. 3. Designed for reliable oral and maxillofacial diagnosis in clinical settings.
OS-SS-X10010DPlus Dental CBCT (Meyer 3-in-1 Intelligent Leader)	1. Product name: Oral and maxillofacial cone beam computed tomography device; 2. Registration: NMPA approval No. 20193060479; 3. Manufacturer: Hefei Meyer Optoelectronic Technology Inc.; 4. Functions: Panoramic, CBCT, and cephalometric imaging in one scan; 5. Applications: Dental implantology, orthodontics, prosthodontics, oral surgery, endodontics, and general clinical diagnosis; 6. Features: 3D spatial structure imaging for objective diagnosis and treatment planning; 7. Model: SS-X10010DPlus; 8. Options: Cloud Leader and Classic King versions available.	1. 3-in-1 dental CBCT system trusted by 20,000+ clinical institutions. 2. One scan generates panoramic, CBCT, and cephalometric views. 3. Provides objective 3D imaging for implant planning, orthodontics, and surgical evaluation. 4. NMPA-registered device with proven reliability in daily clinical practice.
OS-mDX-12DFilm Multi-in-One Dental CBCT	1. Product name: Oral and maxillofacial cone beam computed tomography device; 2. Registration: NMPA approval No. 20223060296; 3. Manufacturer: Hefei Meyer Optoelectronic Technology Inc.; 4. Functions: Cone beam CT, panoramic radiography, cephalometric radiography, and dental radiography; 5. Applications: Oral and maxillofacial X-ray imaging diagnosis; 6. Model: mDX-12DFilm; 7. Features: Hybrid pulse X-ray source technology (patent ZL 2012 1 0275436.2); MyDentViewer system (registration No. 20202210351); 8. Clinical tools: Virtual implant planning, automatic nerve canal labeling, bone density measurement, airway analysis, TMJ module, automatic root-bone separation, cephalometric automation.	1. Multi-in-one dental CBCT system providing a complete oral X-ray imaging solution. 2. One system supports CT, panoramic, cephalometric, and dental modes. 3. Advanced clinical tools: virtual implant planning, nerve detection, bone density, airway analysis, and TMJ assessment. 4. Patented hybrid pulse X-ray technology for high-quality imaging. 5. NMPA-registered for reliable clinical diagnosis and treatment planning.
OS-mDX-13STTB1A High-End Seated Dental CBCT	1. Product name: Oral and maxillofacial cone beam computed tomography device; 2. Registration: NMPA approval No. 20233060525; 3. Manufacturer: Hefei Meyer Optoelectronic Technology Inc.; 4. Functions: Cone beam CT; 5. Applications: Oral and maxillofacial and ENT X-ray imaging diagnosis; 6. Model: mDX-13STTB1A; 7. Features: Automatic panoramic and cephalometric image generation; 3D cephalometric measurement; curved planar reconstruction; re-treatment assessment capability.	1. High-end seated dental CBCT system for comprehensive oral and ENT imaging. 2. Provides advanced imaging including 3D cephalometric analysis and curved planar reconstruction. 3. Automatic generation of panoramic and cephalometric views. 4. NMPA-registered for reliable clinical diagnosis and treatment planning.

Interoral Scanner

Product Name & Model	Parameters & Specifications	Features & Applications
OS-SY-KS1000 MyScan5 Intraoral Scanner (Oral Scanning Intelligent Agent)	1. Product name: Oral digital impression device; 2. Registration: NMPA approval No. 20222170101; 3. Manufacturer: Hefei Meyer Optoelectronic Technology Inc.; 4. Application: Digital impressions of teeth, gingiva, mucosa, and soft/hard tissues for prosthodontics and orthodontics; 5. Model: SY-KS1000; 6. Specifications: Size 248×39×32mm; weight 198g; accuracy ≤10μm; scanning depth 0-20mm; scan head count 5 (autoclavable); output formats STL/PLY/OBJ; gesture control supported; multi-function buttons; 7. Functions: AI detection of caries, calculus, and periodontal disease; multi-modal health report generation; orthodontic model analysis; clinical tools (high-res imaging, margin line drawing, undercut detection, profile analysis, base generation, impression scanning); 8. Features: Ergonomic design; rapid warm-up and anti-fog; OTA updates; cloud data management.	1. Intelligent intraoral scanner with integrated perception, analysis, and evolution capabilities. 2. High accuracy (≤10μm) with 5 autoclavable scan heads for flexible use. 3. AI-powered clinical tools: automatic disease detection, orthodontic simulation, and health report generation. 4. Cloud-connected with OTA updates for continuous performance improvement. 5. NMPA-registered for reliable digital impression workflows.
OS-SY-KS1000 MyScan3 Intraoral Scanner	1. Product name: Oral digital impression device; 2. Registration: NMPA approval No. 20222170101; 3. Manufacturer: Hefei Meyer Optoelectronic Technology Inc.; 4. Application: Digital impressions of teeth, gingiva, mucosa, and soft/hard tissues for prosthodontics and orthodontics; 5. Model: SY-KS1000.	1. Intraoral scanner for digital impression acquisition. 2. Suitable for prosthodontic and orthodontic workflows. 3. NMPA-registered for reliable clinical use.

Otolaryngology CBCT -ENT CBCT

Product Name & Model	Parameters & Specifications	Features & Applications
OS-mDX-13STSP1A High-End ENT CBCT	1. Product name: Oral and maxillofacial cone beam computed tomography device; 2. Registration: NMPA approval No. 20233060525; 3. Manufacturer: Hefei Meyer Optoelectronic Technology Inc.; 4. Functions: Cone beam CT; 5. Applications: X-ray imaging for oral and maxillofacial and ENT (ear, nose, and throat) diagnosis; 6. Model: mDX-13STSP1A; 7. FOV: 23×18cm; 8. Imaging: Paranasal sinus observation, airway analysis, ethmoid sinus osteoma evaluation.	1. High-end CBCT system for both ENT and dental applications. 2. Large FOV (23×18cm) for comprehensive head and neck imaging. 3. Supports sinus assessment, airway analysis, and other ENT diagnostic needs. 4. NMPA-registered for reliable clinical use.

Orthopedic Surgical Robot Systems

Product Name & Model	Parameters & Specifications	Features & Applications
OS-SY-KS1000 Orthopedic Surgical Robot	1. Product name: Spinal surgery navigation and positioning device; 2. Registration: NMPA approval No. 20233010045; 3. Manufacturer: Hefei Meyer Optoelectronic Technology Inc.; 4. Function: Navigation and positioning of surgical instruments and implants during spinal surgery (used with Meyer navigation and positioning tool kit); 5. Model: SY-KS1000.	1. Surgical robot for spinal surgery navigation and instrument positioning. 2. Provides precise guidance for implant placement and surgical tool tracking. 3. NMPA-registered for reliable clinical use in orthopedic and spinal procedures.

Mobile Head CT

Product Name & Model	Parameters & Specifications	Features & Applications
OS-mDX-21explorer Mobile Head CT	1. Product name: X-ray computed tomography device; 2. Registration: NMPA approval No. 20243060365; 3. Manufacturer: Hefei Meyer Optoelectronic Technology Inc.; 4. Application: Routine clinical CT examination of adult heads; 5. Model: mDX-21explorer.	1. Mobile CT system designed for head imaging. 2. Portable for use in various clinical settings. 3. NMPA-registered for routine adult head CT examinations.

Certificates of OROSOL^® Medical Device Manufacturer 8012:

• ISO 13485:2016 — Medical Devices Quality Management System (Certified)
• ISO 9001:2015 — Quality Management System (Certified)
• FDA 510(k) Clearance — Dental CBCT Systems (Class II)
• CE Marking (MDR 2017/745/EU) — Compliance with European Medical Device Regulation
• NMPA Medical Device Registration Certificate (Class II) — Multiple registrations including 国械注准20253060862, 国械注准20233060525, 国械注准20193060479, 国械注准20222170101
• National High-Tech Enterprise Certification (China)
• National Manufacturing Single Champion Enterprise (China)
• National Technology Innovation Demonstration Enterprise (China)
• National Intellectual Property Demonstration Enterprise (China)
• National Enterprise Technology Center (China)
• National Engineering Research Center for Agricultural Product Intelligent Sorting Equipment (China)
• National Postdoctoral Research Workstation (China)
• National Science and Technology Progress Award — Awarded twice
• National Standard Formulation Participation — 12 national and industry standards
• Forbes China Top 100 Most Promising Listed Companies
• China Top 100 Main Board Listed Companies
• China Machinery Top 500
• China New Economy Top 500
• China Innovative Brand Top 500
• China Brand Top 500
• Excellent Domestic Medical Equipment Product — 9th Batch Selection
• WMC Innovation Product Gold Award — World Manufacturing Conference 2019
• RoHS Compliant — Restriction of Hazardous Substances Directive (EU)
• REACH Compliant — Registration, Evaluation, Authorization and Restriction of Chemicals (EU)

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