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Device Identifier (DI) and Production Identifier (PI)

Device Identifier (DI) β€” κΈ°κΈ°μ‹λ³„μžβ€‹

  • Identifies the specific version or model of a device
  • Issued by an authorised issuing agency (GS1 Korea or HIBCC)
  • Must be registered in KIMS with the device's key attributes
  • The same for every unit of a given device model/variant

Production Identifier (PI) β€” μƒμ‚°μ‹λ³„μžβ€‹

Variable portion that includes one or more of:

  • Lot / batch number β€” for most devices
  • Serial number β€” mandatory for implantable and high-risk devices
  • Expiry date β€” for devices with limited shelf life (e.g., sterile devices)
  • Manufacturing date β€” where required

Label requirements by device type​

Device typeDILot/BatchSerialExpiry
Non-sterile, non-implantableβœ“βœ“OptionalOptional
Sterile devicesβœ“βœ“Optionalβœ“
Implantable devicesβœ“βœ“βœ“βœ“ (if applicable)