Custom Medical Specialties

What Custom Medical Specialties does

Custom Medical Specialties (operating as a brand of Custom Assemblies, Inc.) is a privately held US medical device manufacturer founded in 1996 and headquartered at an ISO Class 8 cleanroom facility in Pine Level, North Carolina. The company designs, assembles, packages, and ships sterile and non-sterile fluid management consumables including tubing sets (infiltration, aspiration, injection, and transfer), drain bags, IV extension sets, procedure kits, liposuction and fat grafting cannulas, surgical accessories, and post-surgical compression garments (resold from Caromed). Manufacturing is conducted under FDA 21 CFR Part 820 quality system regulations and ISO 13485 certification, with FDA Registered facility #1063382 and TAA compliance supporting government procurement eligibility. The company also offers contract manufacturing, custom procedure kit assembly, and private labeling services for distributors and OEMs in IV therapy, plastic surgery, urology, and imaging verticals.

The business generates revenue primarily through one-time sales of catalog medical devices priced by case (unit prices ranging from approximately $24 for compression garments to $650 for injection gun sets, with consumable SKUs typically $125-$260 per case) plus contract manufacturing services. Distribution runs through three US/Canada territory-based field sales representatives with explicit rep-to-state assignments, complemented by a direct e-commerce storefront with professional account registration and same-day shipping via UPS daily pickup. Customer segments include hospitals, surgical centers, outpatient clinic networks, surgical specialty practices, MedSpas and aesthetic providers, and medical device distributors. Following the 2025 acquisition of Cobra Surgical, the portfolio has expanded into higher-value capital equipment including aspiration pumps, infiltration pumps, power-assisted liposuction systems, and fat reinjection/harvesting equipment. The company is family-owned, woman-owned, and has no disclosed institutional funding.

Name

Custom Medical Specialties

Legal name

Custom Assemblies, Inc.

Website

https://custommedicalspecialties.com

Company type

Private

Founded year

1996

Operating status

Operating

Headcount range

51–100 employees

Short description

Custom Medical Specialties is a privately held, FDA-registered and ISO 13485-certified medical device manufacturer in Pine Level, NC, producing tubing sets, drain bags, procedure kits, cannulas, and surgical accessories for hospitals, surgical centers, and aesthetic practices across the US and Canada.

Ownership category

akta.pro rank

Product category

Medical Device Manufacturing

NAICS

Surgical Appliance and Supplies Manufacturing (339113), Surgical and Medical Instrument Manufacturing (339112), Medical Equipment and Supplies Manufacturing (3391)

SIC

Surgical & Medical Instruments & Apparatus (3841), Wholesale-Medical, Dental & Hospital Equipment & Supplies (5047)

akta.pro primary industry

Single-Use Surgical Devices & Procedure Packs (Disposable instruments, drapes, kits) (HLAHADAM)

akta.pro secondary industries

Sterile & Aseptic Medical Packaging (Pouches, Wraps, Sterile Barriers) (IMALAIAB), Diagnostic & Laboratory Packaging (Specimen Containers, Transport Tubes) (IMALAIAF)

Keywords

• Medical device manufacturing
• Fluid management products
• Surgical tubing sets
• Sterile procedure kits
• Post-surgical compression garments

Headquarters

HQ city

Pine Level

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Medical Device Sales: Sale of professional-grade medical equipment including tubing sets, drain bags, procedure kits, and surgical accessories. Products sold in case quantities with per-unit pricing.
2. Contract Manufacturing Services: Custom manufacturing, kitting, and private labeling services for healthcare facilities and distributors requiring specialized medical assemblies

Pricing tiers

Go-to-market motion2 records

Distribution channels3 records

Marketing channels4 records

Core offering

Custom Medical Specialties manufactures and distributes specialty medical devices — including tubing sets, drain bags, procedure kits, cannulas, and surgical accessories — from an ISO Class 8 cleanroom facility in Pine Level, NC. The company also offers custom kitting, private labeling, and contract manufacturing services for healthcare facilities and distributors, and resells post-surgical compression garments.

Product overview

Custom Medical Specialties is a medical device manufacturer offering a comprehensive portfolio of fluid management products, drainage systems, and surgical supplies. The core product line centers on CMS Tubing Sets (infiltration, aspiration, injection lines, and transfer sets), CMS Drainbags (drainage bags and collection containers), and Procedure Kits (pre-assembled sterile kits for medical procedures). Supporting products include Band Bags, Extension Sets, and Accessories (infusion handles, aspiration handles, injection gun sets, plunger adaptors, syringe locks, connectors, and cleaning tools). The company also resells Caromed post-surgical compression garments (803 products across 83 styles). Following the 2025 Cobra Surgical acquisition, the portfolio expanded to include aspiration pumps, infiltration pumps, power-assisted liposuction equipment, and specialized medical tubing systems. All products are manufactured in an ISO Class 8 cleanroom facility in North Carolina and maintain FDA 820 and ISO 13485 compliance standards.

Differentiator

Problem solved

Functional benefit

Brands

• Cobra Surgical: Acquired surgical equipment brand specializing in aspiration pumps, infiltration pumps, power-assisted liposuction equipment, specialized medical tubing systems, and fat reinjection/harvesting equipment.

Products and services

• CMS Tubing Sets Professional-grade tubing sets for infiltration, aspiration, injection, and transfer operations in fluid management medical procedures, including single spike and dual spike tumescent sets. For hospitals, surgical centers, and outpatient clinics performing fluid management procedures.
• CMS Drainbags High-quality drainage bags and collection containers for urological and surgical post-operative procedures. For healthcare facilities performing urological and post-operative drainage.
• Procedure Kits Pre-assembled sterile medical kits designed for specific procedures and clinical workflows, with customization for individual healthcare facility needs. For OR surgical teams seeking improved efficiency through pre-assembled procedural supplies.
• Cannulas

Quantifiable outcome

• 43,000+ healthcare facilities nationwide rely on CMS products
• +1 more outcomes

Named customers3 records

Segments4 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

One partnership is on record.

• UPScoreOthersDaily UPS parcel pickup for nationwide delivery of medical products. UPS overnight shipping available before 4:00 PM EST with real-time tracking information. Partnership ensures consistent, dependable delivery critical to uninterrupted patient care for healthcare facilities.

Scale indicators3 records

Recent moves7 records

Expansion highlights6 records

Broad incumbents

• Medline Industries: Medline is one of the largest privately held medical supply manufacturers and distributors, with broad OR/surgical consumable categories that compete head-to-head with CMS's tubing, drain bags, and procedure kits.
• Cardinal Health: Cardinal Health is a major medical products distributor and manufacturer with extensive surgical and OR supply offerings — competing for the same hospital and surgical center customers CMS serves, but at far greater scale.
• Becton Dickinson (BD): BD is a global medical technology incumbent with a broad portfolio including surgical instruments, IV therapy products, and procedure kits — overlapping with CMS across tubing sets, extension sets, and OR consumables as a much larger competitor.

Direct peers

• Tiemann Surgical (Integra LifeSciences): Integra's Tiemann Surgical line offers surgical instruments and accessories used across plastic surgery and OR settings — overlapping with CMS's cannulas, accessories, and procedure-specific kits.
• HK Surgical: HK Surgical manufactures tumescent infiltration pumps, cannulas, and liposuction accessories — directly overlapping with CMS's core fluid management and cannula product lines, especially post-Cobra acquisition.
• MicroAire Surgical Instruments: MicroAire makes power-assisted liposuction (PAL) equipment and surgical instruments — a direct competitor to the newly-acquired Cobra Surgical product line and to the PAL tubing SKUs CMS already sells.
• Aspen Surgical: Aspen Surgical produces single-use surgical instruments, OR consumables, and procedure-related disposables — directly comparable to CMS's procedure kits, tubing sets, and surgical accessories portfolio.
• Wells Johnson Company: Wells Johnson manufactures aspiration and infiltration equipment for liposuction and plastic surgery — a direct peer in capital equipment for the same clinical workflow CMS addresses via Cobra.

Others

• Symmetry Medical / Integer Holdings: Integer Holdings (formerly Symmetry Medical) is a medical device contract manufacturer with cleanroom capabilities — comparable to CMS as an outsourcing partner and adjacent in the medical device manufacturing services value chain.
• Caromed (resale partner): Caromed manufactures post-surgical compression garments that CMS resells under its catalog — an adjacent peer relationship where Caromed is both supplier and a comparable specialty post-op garment manufacturer.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks7 records

Key highlights7 records

Customer concentration

• Facebookfacebook.com/CustomMedicalSpecialties
• LinkedInlinkedin.com/company/custom-medical-specialties
• Instagraminstagram.com/custommedicalspecialties

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Subsidiaries1 record

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 Custom Medical Specialties