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KVSKBAUDILegacyDevice#

Fields#

Name Type Note
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