DARCO

What DARCO does

DARCO International Corporation is a privately held, woman-owned professional services and medical device company headquartered in Sunrise, Florida, with operational offices in Shenzhen, China. Founded in the early 1980s by David Ruben and Ann Hamilton Ruben, the company has operated in the US-APAC corridor for over 40 years and serves medical device, consumer products, beauty, health and wellness, small electrics, and industrial clients across more than 90 countries. Its core technology and service portfolio spans three lines: APAC manufacturing and sourcing management (factory selection, pricing negotiations, contract manufacturing oversight, quality inspections, and logistics); US medical device distribution (acting as FDA Agent, Importer, and Distributor with regulatory alignment support); and APAC medical device distribution (regulatory due diligence, partner search, and market intelligence).

The company's manufacturing capability is anchored by the DARCO-Boon Group joint venture, which operates GMP-certified facilities in Shenzhen (86,000 sq ft with Class 8 cleanrooms and EO sterilization) and Jiangxi Fuzhou, with a Thailand facility under development. Under the Sinton Medical Products sub-brand, DARCO also sells owned single-use high-pressure angiographic syringes, kits, and accessories compatible with Medrad, Guerbet, Bracco, and Nemoto power injector systems. Quality systems operate under ISO 9001, ISO 13485, FDA 21 CFR Part 820, CE, and CFDA frameworks, with additional Canada MDL certification.

DARCO's revenue model combines professional services fees (manufacturing/sourcing and APAC market entry engagements) with managed distribution services (US FDA-aligned importation and channel development), plus product sales through Sinton Medical. Pricing is quote-based with multi-year enterprise contracts and no public disclosure of rates. The go-to-market motion is consultative enterprise field sales targeting medical device companies, international brands seeking US market entry, and consumer products firms pursuing APAC manufacturing, supported by a small team of 11-50 employees. No external funding rounds, institutional investors, or parent company relationships are disclosed.

Name

DARCO

Legal name

DARCO International Corporation, Inc.

Website

https://darcointernational.net

Company type

Private

Founded year

1980

Operating status

Operating

Headcount range

11–50 employees

Short description

DARCO International Corporation is a woman-owned, US-headquartered B2B services firm that helps medical device and consumer products companies manufacture in APAC and distribute in the US and APAC markets, supported by a joint venture manufacturing footprint in China and an expanding Thailand facility.

Ownership category

akta.pro rank

Product category

Medical Device Manufacturing and Distribution Services

NAICS

Surgical Appliance and Supplies Manufacturing (339113), Surgical and Medical Instrument Manufacturing (339112), Drugs and Druggists' Sundries Merchant Wholesalers (42421)

SIC

Surgical & Medical Instruments & Apparatus (3841), Wholesale-Drugs, Proprietaries & Druggists' Sundries (5122)

akta.pro primary industry

Small-Molecule Drug Product (Solid/Oral/Parenteral) CDMO (HLAGABAB)

Keywords

• Medical device manufacturing
• APAC sourcing services
• US medical distribution
• FDA regulatory compliance
• Contract manufacturing services

Headquarters

HQ city

Sunrise

HQ country

United States

HQ region

North America

Offices5 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Supply Chain, Marketing or Sales, Technology or R&D, Infrastructure

Revenue model

1. Manufacturing and Sourcing Services: Professional services fees for managing manufacturing and sourcing operations in APAC. Services include factory selection, pricing negotiations, product development, finished goods inspections, production management, logistics, and contract manufacturing oversight.
2. US Medical Device Distribution Services: Distribution services for medical device companies entering or expanding within the US marketplace. DARCO acts as FDA Agent, Importer, or Distributor, providing regulatory alignment and market access support.
3. APAC Market Entry and Distribution Services: Regulatory due diligence, partner search, and market intelligence services for companies entering or expanding across APAC markets.

Pricing tiers

Go-to-market motion1 record

Distribution channels3 records

Marketing channels3 records

Core offering

DARCO International Corporation provides B2B professional services that include APAC contract manufacturing, sourcing, and global medical device distribution. The company acts as FDA Agent, Importer, and Distributor for international medical device brands seeking U.S. market access, and offers turnkey manufacturing oversight through its DARCO-Boon Group joint venture with GMP-certified facilities in China. Under its Sinton Medical Products brand, it also sells single-use high-pressure angiographic syringes and imaging accessories compatible with major power injector systems.

Product overview

DARCO International Corporation is a woman-owned business providing international growth solutions for innovative brands, with over 40 years of experience operating in the U.S. and APAC regions. The company offers a portfolio of services including manufacturing and sourcing (factory selection, contract manufacturing, product development, logistics), U.S. medical device distribution (regulatory support, FDA agent services, market entry), and APAC medical device distribution. Under the Sinton Medical Products sub-brand, DARCO offers a complete line of single-use, high-pressure angiographic syringes and accessories designed for CT, MRI, and angiographic procedures, compatible with Medrad, Guerbet, Bracco, and Nemoto injector systems. The company also operates a joint venture manufacturing partnership (DARCO-Boon Group) for disposable sterile medical consumables through GMP-certified facilities.

Differentiator

Problem solved

Functional benefit

Products and services

• Sinton Medical Products
• Manufacturing and Sourcing Services
• US Medical Device Distribution Services
• APAC Medical Device Distribution Services
• DARCO-Boon Group Joint Venture Manufacturing

Quantifiable outcome

• 100% Client Satisfaction (as stated on website)
• +2 more outcomes

Named customers2 records

Segments4 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Two partnerships are on record, tiered core.

• Boon Group (DARCO-BOON GROUP Joint Venture)coreStrategic or Co-development PartnerDARCO International partnered with Boon Group through a joint venture agreement utilizing DARCO's global sales and marketing relationships to promote Boon's manufacturing services. Boon Group, founded in 1990, is a comprehensive manufacturing enterprise integrating product development, production, sales, and service of disposable sterile medical consumables. The joint venture includes facilities in Shenzhen and Jiangxi Fuzhou (China) with a Thailand factory under development.
• Sinton Medical ProductscoreOthersSinton Medical Products is a brand operated by DARCO International Corporation, offering high pressure angiographic syringes, tubing and accessories. Products include CT, MRI, and Angiographic syringes compatible with Medrad, Guerbet, Bracco, and Nemoto power injector systems.

Scale indicators6 records

Recent moves6 records

Expansion highlights5 records

Broad incumbents

• Medline Industries: Largest privately held manufacturer and distributor of medical supplies in the US, offering both manufactured devices and distribution services to healthcare providers. Comparable to DARCO's combined manufacturing-and-distribution model at much larger scale.
• McKesson Corporation: Largest US pharmaceutical and medical product distributor. Comparable to DARCO's US medical device distribution and FDA Agent/Importer services at vastly greater scale and broader portfolio.
• Becton, Dickinson and Company (BD): Global medical technology company manufacturing syringes, injection systems, and imaging consumables including angiographic accessories. Direct overlap with Sinton Medical's high-pressure syringe portfolio and adjacent to DARCO's broader sterile medical consumables manufacturing.
• Cardinal Health: Major US medical product distributor with manufacturer sourcing and regulatory services. Overlaps with DARCO's US distribution and importation services for medical device manufacturers.
• Jabil Healthcare: Global contract manufacturing organization with substantial medical device and diagnostics manufacturing capacity in Asia. Comparable to DARCO-Boon JV as a medical device contract manufacturer serving OEMs, though at much larger scale.

Direct peers

• Integer Holdings Corporation: Large medical device contract manufacturer offering outsourced design, development, and manufacturing for medical device OEMs. Comparable to DARCO's Boon JV as a medical device CDMO, though Integer operates at vastly larger scale across multiple geographies.
• AngioDynamics: Medical device company focused on vascular access, peripheral vascular disease, and oncology procedures, including contrast injection consumables used in imaging. Direct overlap with DARCO/Sinton's angiographic procedure consumables.
• ICU Medical: Medical connector and injection systems manufacturer with significant disposable syringe and infusion product lines. Comparable to DARCO/Sinton's sterile consumables focus and cross-compatibility with multiple OEM injector platforms.

Emerging players

• Mack Medical (Clarification: Clarus Medical): Specialty medical device distributor and manufacturer focused on niche surgical and interventional products. Comparable to DARCO's boutique distribution and manufacturing services model for smaller manufacturers seeking market access.

Others

• MasterControl: Provider of quality management and regulatory compliance software for medical device and life sciences companies. Adjacent to DARCO's regulatory and quality systems advisory services, particularly for FDA 21 CFR Part 820 and ISO 13485 compliance.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/darco-international-corporation
• Facebookfacebook.com/darcomfg

Compliance7 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

Subsidiaries4 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about DARCO