Medical Device Marking & UDI Compliance | Imprint Technologies

Industry

Medical Device

Traceability marking, UDI compliance, and precision decoration for regulated components

Medical device manufacturers face strict marking requirements — UDI compliance, lot traceability, and permanent identification that survives sterilization cycles. We've been marking medical components since 1986, working with OEMs on everything from handheld instruments to implantable device packaging.

Marking requirements

UDI compliance

FDA 21 CFR Part 830 — 2D DataMatrix and human-readable text on device and packaging

Sterilization resistance

Marks must survive autoclave (134°C steam), EtO, gamma, and hydrogen peroxide cycles

Biocompatibility

Ink and substrate combinations reviewed for ISO 10993 compatibility on request

Lot traceability

Variable data (lot, serial, date) printed per-part or per-batch with full records

What we mark

  • Surgical instrument handles and grips
  • Diagnostic device housings and panels
  • Implantable device packaging and trays
  • Infusion pump and monitor enclosures
  • Single-use device identification

We work directly with OEM engineering and quality teams to validate marking processes before production. Sample approval, ink adhesion testing, and sterilization validation are standard parts of our onboarding for medical programs. All production records are retained for traceability.

Imprint Technologies

Contract printing & marking since 1986.

952-463-8392[email protected]
4954 Highway 169 North
New Hope, Minnesota 55428
A operating company of Direct Digital Manufacturing Services LLC

© 2026 Imprint Technologies / Direct Digital Manufacturing Services LLC