Adents Partners with Keyence and DNE Consulting to Offer a New Unique Device Identification Turnkey Solution
Adents is pleased to delve into the UDI market for Medical Devices, joining forces with Keyence, innovative leader in the development and manufacturing of industrial automation and inspection equipment worldwide (Printers and Camera) and DNE Consulting, integrator for Packaging, Product Development and Automation requirements.
Adents brings many years of Serialization and Traceability software experience into this partnership. Driven by a shared vision, we strive to offer you innovative solutions based on a standard software platform dedicated to unique product identification and traceability.
What is a Unique Device Identification in GS1 Terms?
UDI Barcode and Print requirements use the same GS1 AI structure and templates as serialization.
UDI has options: either serialized or non-serialized, and are considered compliant.
Reminders regarding the FDA Unique Device Identification Requirements for Medical Devices in the US:
Each UDI must be provided in a plain-text version and in a form that uses automatic identification and data capture (AIDC)
A UDI is a unique numeric or alphanumeric code that consists of two parts:
- A Device Identifier (DI), a mandatory fixed portion of a UDI that identifies the labeler and specific version or model of a device, and
- A Production Identifier (PI), a conditional variable portion of a UDI that identifies one or more of the following when included on the label of a device:
- Lot, date, or batch number within which a device was manufactured
- The serial number of a specific device
- The expiration date of a specific device
- The distinct id code required by §1271.290(c) for a human cell, tissue, or cellular and tissue-based product (HCT/P) regulated as a device
A New UDI-Ready Turnkey Solution for the US Market
Adents, Keyence and DNE Consulting have decided to partner to offer a unique turnkey solution which includes Adents Seriza software, the first standardized serialization solution that is fully configurable, remarkably flexible, and highly scalable.
Keyence will provide the printer solution : an ink-jet device, CO2 laser printer or UV laser solution.
DNE Consulting will ensure a rapid deployment of the customized UDI-ready solution.
- Custom Configuration
- Laser or Ink-Jet Marker
- Mark Verification
- Reject Station