| 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 |
|