MDR-在EUDAMED中提供的UDI和设备数据集.pdf

MDR Device Basic UDI-DI UDI-DI attributes Basic UDI-DI set of data in UDI database Principle: Each UDI-DI inherits the attributes of its linked Basic UDI-DI and devices DI Basic UDI-DI UDI-DIs UDI-DIs •Applicable legislation (MDR) (*) •0. UDI-DI value (*) (container •0b. UDI-DI Issuing Entity (*) •2. Basic UDI-DI value (*) •Secondary DI (value and issuing entity) package DI) •2b Basic UDI-DI Issuing entity (*); •11.B. Reference, Article or Catalogue number (*) •6. Manufacturer SRN (*) •Device with Direct marking (Y/N) (*) •Direct marking UDI-DI value (*) •0. UDI-DI value •5. Name and address of manufacturer •Direct marking UDI-DI issuing entity (*) •7. Name and address and SRN of AR •1. Quantity of device(s) (*) (*) •9. Risk class (*) •3. Type of UDI-PI (*) •0b. Issuing entity •Implantable (Y/N) (*) •4. Unit of use UDI-DI (*) (*) •12. Clinical size (*) •For IIb implantable: Suture, staple, •14. Storage/handling conditions •1. Quantity per dental filling, dental brace, tooth •10-15. Name(s)/Trade name(s) (including package (*) crown, screw, wedge, plate, wire, pin, languages) •24. Status clip, connector (Y/N)