Entry No. | Guid | |
Released | Boolean | |
Internal Version | Integer | |
Active | Boolean | |
Transferred Basic UDI | Boolean | |
Transferred | Boolean | |
Description | Text[100] | |
No. of Exports | Integer | FlowField |
Legal Manufacturer SRN | Text[15] | |
Applicable Legislation | Option | OptionMembers: None,MDR,IVDR,MDD,AIMDD,IVDD |
MultiComponent Device Type | Code[20] | |
Qty. Packages | Integer | FlowField |
Authorised Representative | Text[15] | |
Animal Tissues/Cells | Boolean | |
Clinical Investigation | Boolean | FlowField |
Device Model | Text[120] | |
Device Model Applicable | Boolean | |
Device Name | Text[120] | |
Human Tissues/Cells | Boolean | |
Active Device | Boolean | |
Administer/Remove MedProduct | Boolean | |
Implantable | Boolean | |
Measuring Function | Boolean | |
Reusable Surgical Instruments | Boolean | |
Companion Diagnostic | Boolean | |
Microbial Tissues/Cells | Boolean | |
Near Patient Testing | Boolean | |
Patient Self Testing | Boolean | |
AR Comments | Integer | FlowField |
Device Certificate Information | Integer | FlowField |
EUDAMED DI | Text[120] | FlowField |
Clinks | Integer | FlowField |
Recalled Precisions | Guid | |
Recall Scope | Option | OptionMembers: None,by Lot number,Serial Number |
SubStatusStartDate | Date | |
SubStatusEndDate | Date | |
Device Status | Option | OptionMembers: None,On the market,No longer placed on the market |
Device SubStatus | Option | OptionMembers: None,Recalled,Field safety corrective action initiated |
Unit of Use DI | Text[120] | FlowField |
Secondary UDI - DI | Text[120] | FlowField |
placedOnTheMktCtryId | Text[120] | |
Direct Marking UDI-DI | Text[120] | FlowField |
PDLink | Text[50] | FlowField |
Countriesthedevicesisavailable | Integer | FlowField |
ListofCriticalWarnings | Integer | FlowField |
Clinical Sizes | Integer | FlowField |
Intendedpurposeotherthanmed | Integer | FlowField |
Nomenclature code | Integer | FlowField |
annexXVIapplicable | Boolean | FlowField |
Quantity of Device | Integer | |
LabelledforpresenceofsubstCRM | Boolean | FlowField |
Is the Device directly marked | Boolean | FlowField |
Labelledofsubstendocrine | Boolean | FlowField |
Human Blood/Plasma | Boolean | |
Containing latex | Boolean | |
Maximum number of reuses | Integer | |
Medicinal Substance | Boolean | |
New Device | Boolean | |
OEMApplicable | Boolean | |
ReferenceNumber | Text[120] | |
Reprocessed | Boolean | |
ReusesApplicable | Boolean | |
SingleUse | Boolean | |
Clinical Size Applicable | Boolean | FlowField |
Sterile | Boolean | |
Sterilization | Boolean | |
StorageApplicable | Boolean | FlowField |
TradeNameApplicable | Boolean | |
WarningsApplicable | Boolean | FlowField |
Website | Guid | |
Additional Description | Guid | |
Trade Name | Guid | |
Version | Guid | |
UDI-DI | Text[120] | FlowField |
EUDAMED ID | Text[120] | FlowField |
Related UDI-DI | Text[120] | FlowField |
Relationship Type | Option | OptionMembers: None,Legacy-Regulation Device Link |
Reagent | Boolean | |
Professional Testing | Boolean | |
Instrument | Boolean | |
Exempt frm ImpltblDev Rgultion | Boolean | |
Existing EUDAMED DI | Boolean | |
MFDeviceIdentification | Text[120] | |
Issuing Entity UDI-DI | Code[20] | FlowField |
Issuing Entity Unit of Use DI | Code[20] | FlowField |
Issuing Entity Secondary DI | Code[20] | FlowField |
Iss. Entity Direct Marking DI | Code[20] | FlowField |
Issuing Entity EUDAMED DI | Code[20] | FlowField |
ListofMedprodsubstasstoDevice | Integer | FlowField |
ListofStorageandhandlingCond | Integer | FlowField |
Device Status Date | Date | |
Is it a Kit | Boolean | |
SpecialDeviceType | Code[50] | |
Unit of Use DI Entry No. | Guid | |
Secondary DI Entry No. | Guid | |
Direct Marking DI Entry No. | Guid | |
PDLink Entry No. | Guid | |
Batch Number | Boolean | |
Serialization Number | Boolean | |
Manufacturing Date | Boolean | |
Expiration Date | Boolean | |
Software Identification | Boolean | |
Device Risk Class | Text[50] | |
UDI-DI Entry No. | Guid | |
EUDAMED-ID Entry No. | Guid | |
Issuing Entity EUDAMED ID | Code[20] | FlowField |
Related UDI-DI Entry No. | Guid | |
Related Issuing Entity UDI-DI | Code[20] | FlowField |
EUDAMED-DI Entry No. | Guid | |