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Saint Jones Management LP Eood: FDA-registered device maker in Sofia Sofia-Grad, Bulgaria, 64 510(k) clearances

Saint Jones Management LP Eood is registered with the FDA (registration 3016904853) in Sofia Sofia-Grad, Bulgaria. It lists 68 device types. The FDA files 64 510(k) clearances under its listings, the newest dated March 24, 2023. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3016904853
Address
Stefan Kirov 42, Sofia Sofia-Grad, Bulgaria, 1111
Owner or operator
Saint Jones Management LP EOOD (10074449)
Roles
Exporter to the US, Remanufacturer, Repackager or relabeler
First device listed
May 24, 2020
Registered through
2026
Brand names listed
SAINT JONES

Devices it lists

DeviceProduct codeClassRoleSource
Absorbent, Carbon-DioxideCBL1Repackager or relabeleraccessdata.fda.gov
Absorber, Carbon-DioxideBSF1Repackager or relabeleraccessdata.fda.gov
Accessory, Surgical ApparelLYU1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Anesthesia Conduction KitCAZ2Repackager or relabeleraccessdata.fda.gov
Bandage, ElasticFQM1Remanufactureraccessdata.fda.gov
Bandage, Liquid, Skin ProtectantNEC1Repackager or relabeleraccessdata.fda.gov
Blood Pressure CuffDXQ2Repackager or relabeleraccessdata.fda.gov
Bottle, Collection, VacuumKDQ2Repackager or relabeleraccessdata.fda.gov
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysFOZ2Repackager or relabeleraccessdata.fda.gov
Catheter, Retention Type, BalloonEZL2Repackager or relabeleraccessdata.fda.gov
Condenser, Heat And Moisture (Artificial Nose)BYD1Repackager or relabeleraccessdata.fda.gov
Container, Specimen Mailer And Storage, SterileKDT1Repackager or relabeleraccessdata.fda.gov
Container, Specimen, Non-SterileNNI1Exporter to the USaccessdata.fda.gov
Container, Specimen, SterileFMH1Repackager or relabeleraccessdata.fda.gov
Continuous Measurement ThermometerFLL2Repackager or relabeleraccessdata.fda.gov
Cover, LimbIPM1Exporter to the USaccessdata.fda.gov
Dissector, Surgical, General & Plastic SurgeryGDI1Exporter to the USaccessdata.fda.gov
Dressing, Wound, DrugFROUExporter to the US, Repackager or relabeleraccessdata.fda.gov
Dressing, Wound, HydrophilicNAC1Repackager or relabeleraccessdata.fda.gov
Dressing, Wound, OcclusiveNAD1Repackager or relabeleraccessdata.fda.gov
Electrode, ElectrocardiographDRX2Repackager or relabeleraccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Exporter to the USaccessdata.fda.gov
Filter, Infusion LineFPB2Exporter to the USaccessdata.fda.gov
Gauze/Sponge, Internal, X-Ray DetectableGDY1Exporter to the USaccessdata.fda.gov
Holder, Ear SpeculumJYK1Repackager or relabeleraccessdata.fda.gov
Hysteroscope (And Accessories)HIH2Repackager or relabeleraccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Repackager or relabeleraccessdata.fda.gov
Instrument, Surgical, DisposableKDC1Exporter to the USaccessdata.fda.gov
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentHWE1Exporter to the USaccessdata.fda.gov
Integrated Continuous Glucose Monitoring System, Factory CalibratedQBJ2Repackager or relabeleraccessdata.fda.gov
Introducer, CatheterDYB2Repackager or relabeleraccessdata.fda.gov
Joint, Ankle, External BraceITW1Repackager or relabeleraccessdata.fda.gov
Lamp, SurgicalFTD2Repackager or relabeleraccessdata.fda.gov
Latex Patient Examination GloveLYY1Exporter to the USaccessdata.fda.gov
Light, Headband, SurgicalFSR2Repackager or relabeleraccessdata.fda.gov
Massager, Therapeutic, ElectricISA1Repackager or relabeleraccessdata.fda.gov
Monitor, Bed PatientKMI1Exporter to the USaccessdata.fda.gov
Needle, Aspiration And Injection, DisposableGAA1Remanufactureraccessdata.fda.gov
Needle, Hypodermic, Single LumenFMI2Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Negative Pressure Wound Therapy Powered Suction PumpOMP2Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Over-The-Counter Powered Light Based Laser For AcneOLP2Repackager or relabeleraccessdata.fda.gov
Protector, Skin PressureFMP1Repackager or relabeleraccessdata.fda.gov
Pump, Portable, Aspiration (Manual Or Powered)BTA2Repackager or relabeleraccessdata.fda.gov
Reprocessed Blood Pressure CuffNPP2Repackager or relabeleraccessdata.fda.gov
Set, Administration, IntravascularFPA2Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)HOY1Repackager or relabeleraccessdata.fda.gov
Speculum, Vaginal, NonmetalHIB2Repackager or relabeleraccessdata.fda.gov
Sponge, OphthalmicHOZ2Exporter to the USaccessdata.fda.gov
Stethoscope, ManualLDE1Exporter to the USaccessdata.fda.gov
Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)DWL2Repackager or relabeleraccessdata.fda.gov
Surgeon'S GlovesKGO1Repackager or relabeleraccessdata.fda.gov
Suture, Absorbable, NaturalGAL2Repackager or relabeleraccessdata.fda.gov
Suture, Absorbable, Synthetic, Polyglycolic AcidGAM2Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Suture, Nonabsorbable, SilkGAP2Repackager or relabeleraccessdata.fda.gov
Suture, Nonabsorbable, Steel, Monofilament And Multifilament, SterileGAQ2Repackager or relabeleraccessdata.fda.gov
Suture, Nonabsorbable, Synthetic, PolyamideGAR2Repackager or relabeleraccessdata.fda.gov
Suture, Nonabsorbable, Synthetic, PolyethyleneGAT2Repackager or relabeleraccessdata.fda.gov
Suture, Nonabsorbable, Synthetic, PolypropyleneGAW2Repackager or relabeleraccessdata.fda.gov
Suture, Surgical, Absorbable, PolydioxanoneNEW2Exporter to the USaccessdata.fda.gov
Syringe, AntistickMEG2Repackager or relabeleraccessdata.fda.gov
Syringe, PistonFMF2Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Tape And Bandage, AdhesiveKGX1Repackager or relabeleraccessdata.fda.gov
Toothbrush, PoweredJEQ1Repackager or relabeleraccessdata.fda.gov
Tube, Tracheostomy (W/Wo Connector)BTO2Repackager or relabeleraccessdata.fda.gov
Tubes, Vials, Systems, Serum Separators, Blood CollectionJKA2Exporter to the US, Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Tubing/Tubing With Filter, Insufflation, LaparoscopicNKC1Repackager or relabeleraccessdata.fda.gov
Warmer, Irrigation SolutionLHC1Repackager or relabeleraccessdata.fda.gov
Wound Dressing With Animal-Derived Material(S)KGNURepackager or relabeleraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
March 24, 2023K220212BD Vacutainer® Push Button Blood Collection Set, BD Vacutainer® Push Button Blood Collection Set with Pre-Attached HolderJKASubstantially EquivalentBecton, Dickinson and Companyaccessdata.fda.gov
December 7, 2022K213919Dexcom G7 Continuous Glucose Monitoring SystemQBJSubstantially EquivalentDexcom, Inc.accessdata.fda.gov
May 19, 2022K210983BD Epilor SyringeCAZSubstantially EquivalentBecton, Dickinson and Companyaccessdata.fda.gov
March 31, 2022K220584BD Cathena Safety IV CatheterFOZSubstantially EquivalentBecton Dickinson Infusion Therapy Systems, Inc.accessdata.fda.gov
December 18, 2020K201075BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter, BD Insyte Autoguard BC Pro Shielded IV CatheterFOZSubstantially EquivalentBecton, Dickinson and Companyaccessdata.fda.gov
June 27, 2019K183183VICRYL Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture, PDS II Polydioxanone Sterile Synthetic Absorbable Surgical Suture, PDS Plus Antibacterial Polydioxanone Sterile Synthetic Absorbable Surgical SutureGAMSubstantially EquivalentETHICON, Inc.accessdata.fda.gov
March 20, 2019K183399BD Nexiva Closed IV Catheter SystemFOZSubstantially EquivalentBecton Dickinson Infusion Therapy Systems, Inc.accessdata.fda.gov
April 19, 2018K173757VACUETTE EVOPROTECT Safety Blood Collection / Infusion SetFMISubstantially EquivalentGreiner Bio-One Na, Inc.accessdata.fda.gov
November 21, 2017K1707543M Tegaderm Antimicrobial Transparent Dressing, 3M Tegaderm Antimicrobial I.V. Advanced Securement DressingFROSubstantially Equivalent3M Company, 3M Healthcareaccessdata.fda.gov
December 19, 2016K162081BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse Hypodermic Needle, BD 1ml Luer-lok Insulin SyringeFMFSubstantially EquivalentBecton, Dickinson and Companyaccessdata.fda.gov
November 30, 2016K162450ESPADA Acne-Clearing Blue Light PenOLPSubstantially EquivalentForeo, Inc.accessdata.fda.gov
October 19, 2016K161797Avance Tubing, Avance Y-Connector, Avance ViewPadOMPSubstantially EquivalentMolnlycke Health Care Us, LLCaccessdata.fda.gov
November 13, 2015K152723Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal DevicesHIHSubstantially EquivalentHologic, Inc.accessdata.fda.gov
July 27, 2015K151698BD Angiocath IV Catheter, BD Insyte IV CatheterFOZSubstantially EquivalentBecton Dickinson Infusion Therapy Systems, Inc.accessdata.fda.gov
February 12, 2014K130040MEPITEL AGFROSubstantially EquivalentMolnlycke Health Careaccessdata.fda.gov
April 4, 2013K123507KCI NPWT GAUZE DRESSINGOMPSubstantially EquivalentKci USA, Inc.accessdata.fda.gov
October 18, 2011K112893CLEARLINK LUER ACTIVATED VALVE, CLEARLINK SYSTEM NON-DEHP CATHETER EXTENSION SETSFPASubstantially EquivalentBaxter Healthcare Corporationaccessdata.fda.gov
March 25, 2011K103551INTERLINK S / CLEARLINK SYSTEM / V-LINK LAD WITH VITALSHIELD PROTECTIVE COATING NON-DEHP CATHETER EXTENSION SET KITS,FPASubstantially EquivalentBaxter Healthcare Corpaccessdata.fda.gov
September 15, 2010K100029MEPILEX BORDER AG DRESSINGFROSubstantially EquivalentMolnlycke Health Careaccessdata.fda.gov
March 30, 2010K100559MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEMHIHSubstantially EquivalentInterlace Medical, Inc.accessdata.fda.gov
December 18, 2007K070060WELCH ALLYN FLEXIPORT DISPOSABLE BLOOD PRESSURE CUFF (ONE-PIECE); REUSABLE BLOOD PRESSURE CUFF (ONE-PIECE)DXQSubstantially EquivalentWelch Allyn, Inc.accessdata.fda.gov
September 14, 2007K072320GREINER VACUETTE QUICKSHIELD COMPLETEFMISubstantially EquivalentGreiner Bio-One North America, Inc.accessdata.fda.gov
May 18, 2007K070964KLEENSPEC SINGLE USE VAGINAL SPECULUM AND 790 SERIES CORDLESS ILLUMINATION SYSTEMHIBSubstantially EquivalentWelch Allyn, Inc.accessdata.fda.gov
March 16, 2007K070440BD HYPOINT NEEDLEFMISubstantially EquivalentBecton, Dickinson & COaccessdata.fda.gov
April 10, 2006K053441BIOGEL LATEX POWDER FREE STERILE SURGEON'S GLOVEKGOSubstantially EquivalentRegent Medical Americas, LLCaccessdata.fda.gov
March 10, 2006K053102BIOGEL SKINSENSE POWDER-FREE NON-LATEX SURGEON'S GLOVEKGOSubstantially EquivalentRegent Medical Americas, LLCaccessdata.fda.gov
February 1, 2006K053443BIOGEL ECLIPSE NON-PYROGENIC LATEX POWDER-FREE STERILE SURGEON'S GLOVEKGOSubstantially EquivalentRegent Medical Americas, LLCaccessdata.fda.gov
March 16, 2005K050184BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVEKGOSubstantially EquivalentRegent Medical Americas, LLCaccessdata.fda.gov
March 10, 2004K033880ELECTRO-LUBEGEISubstantially EquivalentMectra Labs, Inc.accessdata.fda.gov
December 29, 2003K033478VACUETTE QUICKSHIELD SAFETY TUBE HOLDERFMISubstantially EquivalentGreiner Bio-One Vacuette North Americaaccessdata.fda.gov
December 5, 2003K032821HYGIA HEALTH SERVICES REPROCESSED BLOOD PRESSURE CUFFNPPSubstantially EquivalentHygia Health Services, Inc.accessdata.fda.gov
August 27, 2003K030381PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE (CUFFED) WITH REUSABLE INNER CANNULABTOSubstantially EquivalentPortex , Ltd.accessdata.fda.gov
May 8, 2003K030573BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET, MODELS 367338, 367344, 367336, 367342, 367335, 367341JKASubstantially EquivalentBd Vacutainer Systems Preanalyical Solutionsaccessdata.fda.gov
May 6, 2003K030580SURETEMP PLUSFLLSubstantially EquivalentWelch Allyn, Inc.accessdata.fda.gov
February 3, 2003K022483ACTISORB SILVER 220 ANTIMICROBIAL BINDING DRESSINGFROSubstantially EquivalentJohnson & Johnson Medical, Ltd.accessdata.fda.gov
January 27, 2003K023971VACUETTE TRACE ELEMENTS TUBESJKASubstantially EquivalentGreiner Bio-One Vacuette North Americaaccessdata.fda.gov
July 19, 2002K021475BD SINGLE LUMEN NEEDLE, SYRINGE AND BLOOD COLLECTION SETFMISubstantially EquivalentBdaccessdata.fda.gov
April 16, 2002K013621BD SAF-T PRN LUER ACTIVATED VALVE, MODEL 385100FPASubstantially EquivalentBecton Dickinson Infusion Therapy Systems, Inc.accessdata.fda.gov
February 14, 2002K014129PROMOGRAN MATRIX WOUND DRESSINGKGNSubstantially EquivalentJohnson & Johnson Medical, Ltd.accessdata.fda.gov
December 21, 2001K013800INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUTOGUARD, AUTOGUARD PRO, INTIMA, AND SAF-T-INTIMA INTRAVASCULAR CATHETEFOZSubstantially EquivalentBecton Dickinson Infusion Therapy Systems, Inc.accessdata.fda.gov
August 17, 2001K012455WELCH ALLYN DURASHOCK BLOOD PRESSURE SYSTEMDXQSubstantially EquivalentWelch Allyn, Inc.accessdata.fda.gov
July 12, 2001K011786VACUETTE SAFETY BLOOD COLLECTION SETFMISubstantially EquivalentGreiner Vacuette North America, Inc.accessdata.fda.gov
June 28, 2001K011699VACUETTE EVACUATED BLOOD COLLECTION TUBESJKASubstantially EquivalentGreiner Bio-One Vacuette North Americaaccessdata.fda.gov
June 13, 2001K011103BD SPRING BASED SYRINGEMEGSubstantially EquivalentBdaccessdata.fda.gov
August 14, 2000K000421BIOGEL NEOTECH II POWDER-FREE NEOPRENE SURGEON'S GLOVEKGOSubstantially EquivalentSsl Americas, Inc. (Regent Medical)accessdata.fda.gov
October 1, 1999K992734BECTON DICKINSON SYRINGEMEGSubstantially EquivalentBd Becton Dickinson Vacutainer Systems Preanalyticaccessdata.fda.gov
January 26, 1999K972615CHEMO PLUS POWDER FREE BLUE LATEX EXAMINATION GLOVES (PROTEIN CONTENT LABELING)LYYSubstantially EquivalentWembley Rubber Products (M) Sdn Bhdaccessdata.fda.gov
June 11, 1998K980987BECTON DICKINSON SYRINGEFMFSubstantially EquivalentBd Becton Dickinson Vacutainer Systems Preanalyticaccessdata.fda.gov
January 8, 1998K972184RUSCH BRILLANT SILICONE FOLEY CATHETEREZLSubstantially EquivalentRusch Intl.accessdata.fda.gov
November 7, 1997K973301ANTI-STICK SYRINGE WITH INTEGRAL HYPODERMIC NEEDLE/VANISHPOINT SYRINGEMEGSubstantially EquivalentRetractable Technologies, Inc.accessdata.fda.gov
December 23, 1996K960492SI CONTROLLER MODEL SI 500BTASubstantially EquivalentI.C Medical, Inc.accessdata.fda.gov
August 30, 1996K960857GREINER VACUETTE BLOOD COLLECTION TUBE W/LITHIUM HEPARIN & GEL SEPARATORJKASubstantially EquivalentGreiner America, Inc.accessdata.fda.gov
June 21, 1996K961225CONTINUFLO SOLUTION SET/SECONDARY MEDICATION SETFPASubstantially EquivalentBaxter Healthcare Corpaccessdata.fda.gov
October 7, 1995K951254SAFETYGLIDE NEEDLEFMISubstantially EquivalentBd Becton Dickinson Vacutainer Systems Preanalyticaccessdata.fda.gov
June 12, 1995K952084HUMID-VENT FILTER PEDIBYDSubstantially EquivalentGibeck, Inc.accessdata.fda.gov
January 18, 1995K945952VACUTAINER(R) BRAND PLUS PST(TM) PLASMA SEPARATION TUBEJKASubstantially EquivalentBd Becton Dickinson Vacutainer Systems Preanalyticaccessdata.fda.gov
January 9, 1995K946173STAINLESS STEEL, GUT, POLY (GLYCOLIDE/L-LACTIDE) POLYAMIDE, POLYPROPYLENE, POLY (ETHYLENE TEREPHTHALATE) AND SILKGAQSubstantially EquivalentETHICON, Inc.accessdata.fda.gov
July 19, 1994K941932SPLASH MASKLYUSubstantially EquivalentIncon Diversified Industries, Inc.accessdata.fda.gov
May 26, 1994K9415621ML LUER-LOK SYRINGEFMFSubstantially EquivalentBd Becton Dickinson Vacutainer Systems Preanalyticaccessdata.fda.gov
February 25, 1994K925791EXAC-TEMP & CLINI-TEMP PROBE W/TEMPERATURE SENSORFLLSubstantially EquivalentDeroyal Industries, Inc.accessdata.fda.gov
January 13, 1989K884421PRE-GAGED BALANCED CUFF W/SYLGARD ANTIMICRO. TREATDXQSubstantially EquivalentPymah Corp.accessdata.fda.gov
July 23, 1985K852211OPSITE WOUND DRESSINGNADSubstantially Equivalent for Some IndicationsSmith & Nephew, Inc.accessdata.fda.gov
March 12, 1984K833916HYPAFIX DRESSING RETENTION SHEETKGXSubstantially EquivalentSmith & Nephew, Inc.accessdata.fda.gov
June 20, 1980K801343B-D FILTER NEEDLEFPBSubstantially EquivalentBd Becton Dickinson Vacutainer Systems Preanalyticaccessdata.fda.gov

Compare with other makers

Updated March 24, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.