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Experts in Medical Device
Manufacturing & Distribution

Whether you're expanding into the Asian marketplace, sourcing overseas, or entering the US medical device market, DARCO International provides end-to-end solutions across medical devices, life sciences, consumer health, beauty, and industrial sectors.

Explore Our Services Get in Touch

Our Core Services

Comprehensive support for global medical device companies

Manufacturing & Sourcing

Leverage our strategic partnerships in China and Asia to manufacture high-quality medical devices with strict compliance to ISO, FDA, and CE standards. We manage the entire supply chain from design to delivery.

USA Medical Device Distribution

Gain seamless access to the U.S. healthcare market with our established distribution network, regulatory expertise, and logistics support tailored for medical device compliance and rapid market entry.

APAC Medical Device Distribution

Expand into Asia-Pacific with confidence. We offer localized distribution strategies, regulatory navigation, and market intelligence for successful entry into China, Japan, South Korea, and Southeast Asia.

About DARCO International

DARCO International Corporation is a trusted leader in medical device manufacturing and distribution, with deep expertise in bridging the U.S. and Asian markets. Our mission is to empower innovators by simplifying global expansion, ensuring regulatory compliance, and delivering high-quality products on time.

With operations rooted in both Sunrise, Florida, and strategic manufacturing hubs in China, we offer a unique dual-market advantage. Our team combines engineering excellence, supply chain mastery, and regulatory insight to support clients across the medical, life sciences, consumer health, beauty, and industrial sectors.

  • ISO & FDA-compliant manufacturing
  • End-to-end supply chain management
  • Regulatory consulting for US and APAC markets
  • Strategic joint ventures and private labeling
Medical Device Lab Engineering Team Factory Floor Product Testing

Featured Medical Devices & Solutions

High-quality, compliant products manufactured and distributed globally

Surgical Instruments Set

Surgical Instruments Set

Precision-engineered stainless steel tools for general surgery, sterilization-ready, ISO 13485 certified.

  • • Material: 316L Stainless Steel
  • • Compliance: FDA, CE, ISO 13485
  • • Packaging: Sterile blister pack
Diagnostic Imaging Device

Portable Ultrasound Scanner

Compact, high-resolution imaging for point-of-care diagnostics, compatible with mobile platforms.

  • • Resolution: 1080p real-time imaging
  • • Power: Rechargeable Li-ion battery
  • • Certifications: FDA 510(k), CE Mark
Wearable Health Monitor

Wearable ECG Monitor

Continuous cardiac monitoring with Bluetooth sync, ideal for remote patient monitoring programs.

  • • Sensors: 3-lead ECG
  • • Connectivity: BLE 5.0
  • • Compliance: HIPAA, GDPR ready
Infusion Pump

Smart Infusion Pump

Programmable IV delivery system with dose error reduction software and wireless monitoring.

  • • Flow Rate: 0.1–1200 mL/hr
  • • Safety: DERS & alarm integration
  • • Standards: IEC 60601-1, UL 60601
Dental Handpiece

High-Speed Dental Handpiece

Ergonomic design with turbine motor, autoclavable, low vibration for precision dentistry.

  • • Speed: Up to 400,000 RPM
  • • Material: Aerospace-grade aluminum
  • • Certification: ISO 9001, ISO 13485
Orthopedic Implants

Orthopedic Implant Kits

Titanium and PEEK-based implants for spinal, trauma, and joint reconstruction procedures.

  • • Materials: Ti-6Al-4V, PEEK-OPTIMA
  • • Surface: Plasma-sprayed hydroxyapatite
  • • Compliance: FDA PMA, CE Class III
Respiratory Ventilator

Critical Care Ventilator

Invasive and non-invasive modes for ICU and emergency use with integrated monitoring.

  • • Modes: AC, SIMV, CPAP, PRVC
  • • Display: 15” touchscreen interface
  • • Standards: ISO 80601-2-12
Patient Monitor

Multi-Parameter Patient Monitor

Vital signs tracking with ECG, SpO2, NIBP, temperature, and respiratory rate in one compact unit.

  • • Parameters: 5+ vital signs
  • • Connectivity: HL7, Wi-Fi, USB
  • • Battery: 4-hour runtime
Autoclave Sterilizer

Tabletop Autoclave

Class B steam sterilizer for clinics and labs, fast cycle times, digital control panel.

  • • Chamber: 18L stainless steel
  • • Cycle Time: As low as 25 min
  • • Standards: EN 13060, FDA cleared
Dermatology Laser

Fractional CO2 Laser

Aesthetic and dermatological resurfacing system with adjustable power and scanning patterns.

  • • Wavelength: 10,600 nm
  • • Power: 1–60 W adjustable
  • • Applications: Skin resurfacing, scar revision
15+
Years of Industry Experience
50+
Global Clients Served
200+
Medical Devices Manufactured
12
Countries Market Reach

Frequently Asked Questions

Where is DARCO International headquartered?

Our U.S. headquarters is located at 510 Shotgun Road, Suite 520, Sunrise, FL 33326. We also maintain manufacturing and distribution operations in China.

Can DARCO help with FDA registration?

Yes, we provide full regulatory support including FDA 510(k) submissions, QSR compliance, and quality system audits for medical device manufacturers.

Do you offer private labeling?

Absolutely. We specialize in OEM and ODM manufacturing with full private labeling, packaging design, and branding support.

What regions do you distribute to?

We distribute across the United States and throughout the APAC region, including China, Japan, South Korea, Singapore, Thailand, and Australia.

Are your manufacturing facilities ISO certified?

Yes, all our partner factories are ISO 13485, ISO 9001, and CE certified, with regular audits to ensure compliance with international standards.

Get in Touch with Our Team

Ready to bring your medical device to market? Contact DARCO International for expert manufacturing, sourcing, and distribution support.

Phone: 754-300-1785
Fax: 877-804-4505
Address: 510 Shotgun Road, Suite 520, Sunrise, FL 33326
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