Counterfeit and non-conforming devices put patients at risk, and regulators expect unique device identification. Traciqo gives each device a GS1-standard serialised identity for authentication, UDI-style traceability, scan verification and precise recalls — supporting your compliance obligations.
From counterfeits to field-safety recalls, medical devices need unit-level identification regulators and hospitals can rely on.
Fake or substandard devices endanger patients and expose manufacturers to serious liability.
Regulators require unique device identification, with device and production identifiers on labelling.
When a device must be corrected or removed, reaching the right units fast is critical.
Built on the GS1 identifiers used for UDI.
Encode the device identifier (GTIN) plus production identifiers — serial/lot (21/10) and expiry (17) — in a GS1 Digital Link.
Clinicians, distributors and patients verify a device's authenticity with a single scan.
Surface lot, serial and expiry to support handling, dispensing and traceability.
Log servicing, calibration and events against the exact unit over its life.
Scope recalls and corrective actions to specific lots or serials and flag affected units on scan.
Scan events show where and when devices are checked across the chain.
Traciqo provides GS1-based device identification, authentication, traceability and recall support. It complements — and does not replace — statutory UDI databases such as the FDA's GUDID or the EU's EUDAMED that you are required to submit to.
Yes. Each device can carry a GS1 Digital Link encoding the device identifier (GTIN) and production identifiers — serial or lot and expiry — the building blocks of Unique Device Identification, for per-unit authentication and traceability.
Traciqo provides device identification, authentication, traceability and recall support built on GS1 standards. It complements your processes; it is not a replacement for statutory UDI databases such as the FDA GUDID or EU EUDAMED that you must submit to.
Each unit has a unique serialised code checked against your records. A scan confirms whether the device is genuine and surfaces lot and expiry, while abnormal scan patterns on a code can flag possible copying.
Yes. Recalls and corrective actions can be scoped to specific lots or serials, with affected units flagged at the point of scan and stakeholders notified.
GS1-based authentication, traceability and recall for medical devices — starting free.