Unique Device Identification (UDI)
GPTKB entity
Statements (30)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
medical device identification system
|
| gptkbp:abbreviation |
gptkb:UDI
|
| gptkbp:appliesTo |
medical devices
in vitro diagnostic devices |
| gptkbp:consistsOf |
Device Identifier (DI)
Production Identifier (PI) |
| gptkbp:enables |
recall management
improved post-market surveillance traceability of medical devices |
| gptkbp:format |
machine-readable
human-readable |
| gptkbp:goal |
improve patient safety
reduce medical errors facilitate device recalls |
| https://www.w3.org/2000/01/rdf-schema#label |
Unique Device Identification (UDI)
|
| gptkbp:introducedIn |
2013 (USA)
|
| gptkbp:machineReadableFormat |
gptkb:RFID
barcode QR code |
| gptkbp:recordedAt |
European Database on Medical Devices (EUDAMED)
Global Unique Device Identification Database (GUDID) |
| gptkbp:regulates |
gptkb:European_Parliament
gptkb:U.S._Food_and_Drug_Administration |
| gptkbp:requires |
EU Medical Device Regulation (MDR)
EU In Vitro Diagnostic Regulation (IVDR) FDA UDI Rule |
| gptkbp:standardizedBy |
International Medical Device Regulators Forum (IMDRF)
|
| gptkbp:usedFor |
identifying medical devices
|
| gptkbp:bfsParent |
gptkb:Medical_Device_Regulation
|
| gptkbp:bfsLayer |
7
|