DARCO
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.
- Company typePrivate
- Founded1980
- HeadquartersSunrise, United States
- Headcount11–50
- GTM typeB2B
- OfferingServices
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.
DARCO firmographics
Firmographics- 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
DARCO industry classification
Industry- 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
Where DARCO is headquartered
LocationHeadquarters
- HQ city
- Sunrise
- HQ country
- United States
- HQ region
- North America
Offices5 records
Markets served
DARCO business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Supply Chain, Marketing or Sales, Technology or R&D, Infrastructure
Revenue model
- 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.
- 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.
- 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
| Model | Billing | Price |
|---|---|---|
| Other | Multi-year contract | Custom enterprise engagement |
Go-to-market motion1 record
Distribution channels3 records
Marketing channels3 records
DARCO product offering
Product offeringCore 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
Companies that use DARCO
Customer profileNamed customers2 records
Segments4 records
Ideal customer profiles4 records
DARCO technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature3 records
DARCO partnerships and signals
Strategic signalPartnerships
Two partnerships are on record, tiered core.
- Boon Group (DARCO-BOON GROUP Joint Venture)coreDARCO 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 ProductscoreSinton 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
DARCO competitors and assessment
Company assessmentBroad 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
DARCO social profiles
Digital presenceDARCO compliance and trust
Trust signalCompliance7 records
DARCO financial estimates
Financial estimateRevenue estimate
Valuation estimate
DARCO leadership team
Management profileNumber of profiles
Profiles2 records
DARCO subsidiaries and ownership
Company hierarchySubsidiaries4 records
DARCO funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
DARCO M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about DARCO
What does DARCO do?
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.
Is DARCO a public or private company?
DARCO is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was DARCO founded?
DARCO was founded in 1980. It employs 11 to 50 people.
Where is DARCO based?
DARCO is headquartered in Sunrise, United States, in the North America region.
How does DARCO make money?
Three revenue lines are on record. Manufacturing and Sourcing Services are the primary driver. The others are US Medical Device Distribution Services and APAC Market Entry and Distribution Services.
Who are DARCO's main competitors?
Broad incumbents on record are Medline Industries, McKesson Corporation, Becton, Dickinson and Company (BD), Cardinal Health and Jabil Healthcare. Direct peers are Integer Holdings Corporation, AngioDynamics and ICU Medical. Mack Medical (Clarification: Clarus Medical) is listed as an emerging player. MasterControl is listed as an others.
Does DARCO have an API?
No public API is recorded for DARCO.
What industry is DARCO in?
DARCO's product category is Medical Device Manufacturing and Distribution Services. Its primary akta.pro industry code is HLAGABAB, Small-Molecule Drug Product (Solid/Oral/Parenteral) CDMO. Its NAICS code is 339113 and its SIC code is 3841.