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Data / Medical devices / Netherlands / Bmmedical

Bmmedical: FDA-registered device maker in Lelystad Flevoland, Netherlands, 23 510(k) clearances

Bmmedical is registered with the FDA (registration 3031233007) in Lelystad Flevoland, Netherlands. It lists 22 device types. The FDA files 23 510(k) clearances under its listings, the newest dated April 10, 2026. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

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FDA registration number
3031233007
Address
Charles Lindberghlaan 8, Lelystad Flevoland, Netherlands, 8218 NS
Owner or operator
BMmedical (10090850)
Roles
Exporter to the US
First device listed
May 22, 2024
Registered through
2026
Brand names listed
ANESTHESIOLOGY, Bandages, Blood collection, Cardiovascular, Cardiovascular Adaptor, Catheter, Condenser, Container and more

Devices it lists

DeviceProduct codeClassRoleSource
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary BypassDTL2Exporter to the USaccessdata.fda.gov
Bandage, ElasticFQM1Exporter to the USaccessdata.fda.gov
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysFOZ2Exporter to the USaccessdata.fda.gov
Condenser, Heat And Moisture (Artificial Nose)BYD1Exporter to the USaccessdata.fda.gov
Container, Specimen, SterileFMH1Exporter to the USaccessdata.fda.gov
Device, Intravascular Catheter SecurementKMK1Exporter to the USaccessdata.fda.gov
Drape, Surgical, ExemptPUI2Exporter to the USaccessdata.fda.gov
Dressing, Wound, HydrophilicNAC1Exporter to the USaccessdata.fda.gov
Dressing, Wound, OcclusiveNAD1Exporter to the USaccessdata.fda.gov
Irrigator, OstomyEXD2Exporter to the USaccessdata.fda.gov
Needle, Aspiration And Injection, DisposableGAA1Exporter to the USaccessdata.fda.gov
Needle, Hypodermic, Single LumenFMI2Exporter to the USaccessdata.fda.gov
Set, Administration, IntravascularFPA2Exporter to the USaccessdata.fda.gov
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention FeatureFMK2Exporter to the USaccessdata.fda.gov
Spirometer, Therapeutic (Incentive)BWF2Exporter to the USaccessdata.fda.gov
Syringe, Irrigating (Non Dental)KYZ1Exporter to the USaccessdata.fda.gov
Syringe, PistonFMF2Exporter to the USaccessdata.fda.gov
Tape And Bandage, AdhesiveKGX1Exporter to the USaccessdata.fda.gov
Transducer, Blood-Pressure, ExtravascularDRS2Exporter to the USaccessdata.fda.gov
Tube Tracheostomy And Tube CuffJOH2Exporter to the USaccessdata.fda.gov
Tube, Tracheostomy (W/Wo Connector)BTO2Exporter to the USaccessdata.fda.gov
Tubes, Vials, Systems, Serum Separators, Blood CollectionJKA2Exporter to the USaccessdata.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
April 10, 2026K252506BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Blood Collection Set with Pre-Attached HolderJKASubstantially EquivalentBecton, Dickinson and Companyaccessdata.fda.gov
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
March 10, 2023K222478BD Vacutainer® Luer-Lok™ Access Device, BD Vacutainer® Blood Transfer DeviceJKASubstantially EquivalentBecton, Dickinson and Companyaccessdata.fda.gov
August 12, 2022K221126Unistik® 3, sterile single-use safety lancets; Unistik® 3 Value, sterile single-use safety lancets; Abbott SF sterile single-use safety lancetsFMKSubstantially EquivalentOwen Mumford, Ltd.accessdata.fda.gov
February 4, 2022K212724BD Vacutainer UltraTouch Push Button Blood Collection SetJKASubstantially EquivalentBecton, Dickinson and Companyaccessdata.fda.gov
March 20, 2019K183399BD Nexiva Closed IV Catheter SystemFOZSubstantially EquivalentBecton Dickinson Infusion Therapy Systems, Inc.accessdata.fda.gov
June 29, 2010K101502BD VACUTAINER RAPID SERUM TUBE BLOOD COLLECTION TUBE, MODEL 368774JKASubstantially EquivalentBecton, Dickinson & COaccessdata.fda.gov
August 25, 2009K091292BD VACUTAINER RAPID SERUM TUBE PLUS BLOOD COLLECTION TUBE, MODEL 368771JKASubstantially EquivalentBecton, Dickinson and Company (BD)accessdata.fda.gov
January 10, 2006K053106TEGO, MODEL D1000FPASubstantially EquivalentIcu Medical, Inc.accessdata.fda.gov
May 14, 2004K041071BD VACUTAINER TRACE ELEMENT SERUM PLUS TUBE AND BD VACUTAINER TRACE ELEMENT K2EDTA PLUS TUBE, MODELS 368380/368381JKASubstantially EquivalentBecton, Dickinson & COaccessdata.fda.gov
July 19, 2002K021475BD SINGLE LUMEN NEEDLE, SYRINGE AND BLOOD COLLECTION SETFMISubstantially EquivalentBdaccessdata.fda.gov
December 5, 2000K002768ACAPELLABWFSubstantially EquivalentDhd Healthcare Corp.accessdata.fda.gov
June 15, 1999K991599CADD ADMINISTRATION SETFPASubstantially EquivalentSims Deltec, Inc.accessdata.fda.gov
October 28, 1998K982541VACUTAINER BRAND ECLIPSE BLOOD COLLECTION NEEDLE, MODELS# 368607 & 368608FMISubstantially EquivalentBecton Dickinson Vacutainer Systemsaccessdata.fda.gov
March 3, 1998K980414VACUTAINER BRAND SAFETY-LOK BLOOD COLLECTION SET MODEL MULTIPLE, VACUTAINER BRAND BLOOD COLLECTION SETJKASubstantially EquivalentBd Becton Dickinson Vacutainer Systems Preanalyticaccessdata.fda.gov
October 7, 1995K951254SAFETYGLIDE NEEDLEFMISubstantially EquivalentBd Becton Dickinson Vacutainer Systems Preanalyticaccessdata.fda.gov
October 27, 1994K944178BIVONA FLEXTEND PEDIATRIC & NEONATAL TRACHEOSTROMY TUBESJOHSubstantially EquivalentBivona Medical Technologiesaccessdata.fda.gov
February 9, 1994K933390REMOTE RESERVOIR ADAPTER(TM) CASSETTE WITH BAGFPASubstantially EquivalentPharmacia Deltec, Inc.accessdata.fda.gov
January 30, 1992K913859BIVONA FOME-CUF(R) & AIR CUF(R), MODIFICATIONJOHSubstantially EquivalentBivona Medical Technologiesaccessdata.fda.gov
October 23, 1991K914088BIVONA AIRE-CUF(R) PEDIATRIC TRACHEOSTOMY TUBEJOHSubstantially EquivalentBivona Medical Technologiesaccessdata.fda.gov
June 19, 1991K912469BIVONA WIRE REINFORCED PEDIATRIC TRACHEOSTOMY TUBEBTOSubstantially EquivalentBivona Medical Technologiesaccessdata.fda.gov
April 22, 1991K910764THE PERCEPTOR(TM) STAND ALONE TRANSDUCERDRSSubstantially EquivalentNorth American Instrument Corp.accessdata.fda.gov
June 26, 1990K900652NAMIC PTCA Y-ADAPTORDTLSubstantially EquivalentNorth American Instrument Corp.accessdata.fda.gov

Compare with other makers

Updated April 10, 2026. 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.