Custom Manufacturing Inc. logoCustom Manufacturing Inc.

Capability statement

Capabilities for commercial and federal programs

Custom Manufacturing Incorporated provides medical device manufacturing, assembly, cleanroom packaging, and labeling — plus federal contracting readiness with CAGE, UEI, NAICS and PSC registrations in place.

CAGE
4BLB3
UEI
NCDLC65N8U94

Core competencies

What we build and package

  • Medical Device Manufacturing & Assembly
  • Manufacturing of Electrosurgical Instruments
  • Manufacturing of Cardiac Insulation Pads
  • Simple to Complex Manufacturing & Assembly
  • Automated & Non-Automated Manufacturing
  • Cleanroom Packaging & Sealing
  • Impulse & Pneumatic Heat Sealing
  • Kit Assembly, Packaging & Labeling
  • Product Label (LVS, Barcode, Basic)

Sealing methods include pneumatic, heat, impulse, and pouch sealing. Labeling ranges from simple information labels up to Microscan LVS barcode label verification. Cleanroom work is performed in our ISO Class 7 Controlled Environment.

Differentiators

Why buyers choose CMI

WOSB Certified
Blueprint-to-production ready
FDA registered facility #1721251
ISO 13485:2016 Certified QMS
ISO 14644-1:2015 Certified Cleanroom environment
100+ years combined industry experience
Hands-on non-automated services
Non-disclosure agreements for clients

Past performance

Programs we have supported

  • Covidien
  • Medtronic
  • Integra LifeSciences
  • Viant Medical

Client product designs and finished devices are protected under non-disclosure agreements and are not displayed.

Federal contracting

Codes & registrations

NAICS Codes
561910, 339112, 339113
PSC Codes
8135, 6515, 3391
CAGE Code
4BLB3
UEI
NCDLC65N8U94
FDA Registration
#1721251
Small business status
WOSB / WBENC certified

Let's get in touch

Ready to move from blueprint to production?

Tell us about your device, assembly, or packaging program. We'll review your requirements and respond with a scoped quote — NDAs available on request.