Certificates and Compliances

What is in UDI (2s Data Matrix)?

Unique Device Identifiers

Legal requirements for Manufacturers under Medical Device Directive - mandatory on Risk Class I-Ir after 2026. 

Will contain: 

  • (01) GTIN Global Trade Identification Number (globally unique Part Number)
  • (10) Lot Nr

Customers benefit from the UDI as it enables easy tracking of devices for safety and asset management purposes through the GTIN number. Information such as Supplier/Brand Name, Supplier Part Number, Country of Origin, Product Family, Regulatory Certificate Number and much more can be extracted.

We are proud to have completed our implementations to comply with the new device directive well ahead of the implementation date. 

UDI marked Instrument & Packaging

Compliance... how do we benefit? 

  • Higher level of protection of Human Health & Safety
  • Stringent Device Classification and Evaluation (more Technical Documentation Requirements)
  • Culture of continual review & improvement
  • Improved manufacturer image and credibility
  • Applies evidence-based decision making
  • UDI (Unique Device Identifier) implementation

How this helps our customer...

  • Track instruments: establish detailed history of the use of an instrument within the hospital, instrument lifespan, service and maintenance history, asset management
  • Traceability - evidence based tracing of devices in relation to incidents and recalls
  • Quality - customer confidence in suppliers and device brands with regard to compliance, standards and ongoing commitment to improvements

 

Inka Surgical Perth
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