Industry
Medical & Healthcare Manufacturing
Wrex Products is FDA-registered as a device establishment (Owner/Operator #10049354) and currently manufactures under active device listings as a contract manufacturer and repackager/relabeler for powered and non-powered breast pump devices. Medical-related components carry documentation and traceability requirements that general industrial parts don't — see Quality & Certifications for our full, current certification and registration status before relying on any specific claim.
Materials & processes we use most
- Injection molding of medical-grade and biocompatible-candidate resins (material biocompatibility certification is the customer's or material supplier's responsibility to confirm for the specific application)
- Insert molding for components combining plastic with metal inserts
- Precision CNC machining for tight-tolerance features
- Medical device assembly, including contract manufacturing and repackaging/relabeling of powered and non-powered breast pump devices under active FDA device listings
- ESD-controlled assembly where the device requires it
Quality considerations
- Material traceability and lot documentation
- First-article and in-process inspection records
- Change control for approved tooling and processes
- Cleanliness and contamination control appropriate to the component (we have a portable, non-certified mobile cleanroom — raise any certified-classification requirement in advance)
Manufacturing challenges we help solve
- Validating a design for moldability without compromising a biocompatibility-driven material choice
- Maintaining process consistency across long production runs where a device's regulatory submission depends on unchanged manufacturing parameters
- Coordinating tooling changes through a documented change-control process
Documentation
- Certificates of conformance
- Material lot traceability
- First-article inspection reports
- Additional documentation packages available by program agreement
Frequently asked questions
Is Wrex FDA-registered, and what does that mean?
Yes — Wrex Products is registered with the FDA as a device establishment (Owner/Operator #10049354) with active device listings. FDA facility registration and device listing does not, in any way, constitute FDA approval of the facility or its devices — see Quality & Certifications for the full registration detail.
Is Wrex ISO 13485 certified?
See Quality & Certifications for the current certificate detail (scope, certificate number, registrar, and dates) and an open question we're confirming about the registrar's accreditation status before using the word "certified" without qualification.
Can you manufacture in a cleanroom environment?
Wrex does not have a certified cleanroom. We do have a portable, mobile cleanroom that is not certified to a cleanroom class. If your part requires work in a certified, classified environment, that is not something we can offer today — tell us at RFQ rather than assuming. If your requirement is contamination control rather than a certified class, the mobile cleanroom may well fit, and we'll talk it through.
Ready to talk about your project?
Send your drawings or describe your part — an engineer will follow up, not a sales queue.