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Data / Medical devices / Netherlands / Essity Distribution B.V.

Essity Distribution B.V.: FDA-registered device maker in GE Oostrum Fryslan, Netherlands, 9 510(k) clearances

Essity Distribution B.V. is registered with the FDA (registration 3017633586) in GE Oostrum Fryslan, Netherlands. It lists 44 device types. The FDA files 9 510(k) clearances under its listings, the newest dated August 21, 2017. 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.

Get makers like this oneWatch Essity Distribution B.V.
FDA registration number
3017633586
Address
c/o CEVA Logistics Netherlands B.V. Bellstraat 20, GE Oostrum Fryslan, Netherlands, 5807
Owner or operator
BSN medical GmbH (9047426)
Roles
Exporter to the US
First device listed
December 27, 1983
Registered through
2026
Brand names listed
, Jobst Comprifore #2, ACTIMOVE, ACTIMOVE KIDS ELBOW SUPPORT, ADJUSTABLE, ACTIMOVE KIDS WRIST STABILIZER, REMOVABLE METAL STAY, LEFT OR RIGHT, ACTIMOVE POST-OP ROM KNEE BRACE, ACTIMOVE PROFESSIONAL LINE MANUS, WRIST STABILIZER, ACTIMOVE SOLEA, Actimove Alufoam and more

Devices it lists

DeviceProduct codeClassRoleSource
Aid, TransferIKX1Exporter to the USaccessdata.fda.gov
Band Or Belt, Pelvic SupportISR1Exporter to the USaccessdata.fda.gov
Bandage, CastITG1Exporter to the USaccessdata.fda.gov
Bandage, ElasticFQM1Exporter to the USaccessdata.fda.gov
Bandage, Liquid, Skin ProtectantNEC1Exporter to the USaccessdata.fda.gov
Binder, AbdominalFSD1Exporter to the USaccessdata.fda.gov
Binder, BreastHEF1Exporter to the USaccessdata.fda.gov
Binder, Medical, TherapeuticMDR1Exporter to the USaccessdata.fda.gov
Component, CastLGF1Exporter to the USaccessdata.fda.gov
Cover, CastKIA1Exporter to the USaccessdata.fda.gov
Cover, LimbIPM1Exporter to the USaccessdata.fda.gov
Dressing, Wound, DrugFROUExporter to the USaccessdata.fda.gov
Dressing, Wound, Hydrogel Without Drug And/Or BiologicNAE1Exporter to the USaccessdata.fda.gov
Dressing, Wound, HydrophilicNAC1Exporter to the USaccessdata.fda.gov
Dressing, Wound, OcclusiveNAD1Exporter to the USaccessdata.fda.gov
Gauze / Sponge,Nonresorbable For External UseNAB1Exporter to the USaccessdata.fda.gov
Instrument, Cast Application/Removal, ManualLGG1Exporter to the USaccessdata.fda.gov
Joint, Ankle, External BraceITW1Exporter to the USaccessdata.fda.gov
Joint, Knee, External BraceITQ1Exporter to the USaccessdata.fda.gov
Orthosis, AbdominalKTD1Exporter to the USaccessdata.fda.gov
Orthosis, CervicalIQK1Exporter to the USaccessdata.fda.gov
Orthosis, Corrective ShoeKNP1Exporter to the USaccessdata.fda.gov
Orthosis, Limb BraceIQI1Exporter to the USaccessdata.fda.gov
Orthosis, LumbarIQE1Exporter to the USaccessdata.fda.gov
Orthosis, Lumbo-SacralIPY1Exporter to the USaccessdata.fda.gov
Orthosis, Rib Fracture, SoftIPX1Exporter to the USaccessdata.fda.gov
Orthosis, Truncal/Orthosis, LimbMRI1Exporter to the USaccessdata.fda.gov
Pack, Hot Or Cold, DisposableIMD1Exporter to the USaccessdata.fda.gov
Pack, Hot Or Cold, ReusableIME1Exporter to the USaccessdata.fda.gov
Pad, EyeHMP1Exporter to the USaccessdata.fda.gov
Protector, Skin PressureFMP1Exporter to the USaccessdata.fda.gov
Shoe, CastIPG1Exporter to the USaccessdata.fda.gov
Sling, ArmILI1Exporter to the USaccessdata.fda.gov
Sling, Arm, Overhead SupportedILE1Exporter to the USaccessdata.fda.gov
Splint, ClavicleIQJ1Exporter to the USaccessdata.fda.gov
Splint, Extremity, Non-Inflatable, External, Non-SterileNOC1Exporter to the USaccessdata.fda.gov
Splint, Extremity, Noninflatable, External, SterileFYH1Exporter to the USaccessdata.fda.gov
Splint, Hand, And ComponentsILH1Exporter to the USaccessdata.fda.gov
Stocking, Medical Support (For General Medical Purposes)FQL1Exporter to the USaccessdata.fda.gov
Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)DWL2Exporter to the USaccessdata.fda.gov
Support, ArmIOY1Exporter to the USaccessdata.fda.gov
Tape And Bandage, AdhesiveKGX1Exporter to the USaccessdata.fda.gov
Venous Ulcer KitPYK1Exporter to the USaccessdata.fda.gov
Wound Dressing With Animal-Derived Material(S)KGNUExporter 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
August 21, 2017K171225Sorbact Wound Dressing-Ribbon GauzeFROSubstantially EquivalentAbigo Medical ABaccessdata.fda.gov
July 1, 2016K153674Sorbact Foam Gentle Border, Sorbact SuperabsorbentFROSubstantially EquivalentAbigo Medical ABaccessdata.fda.gov
January 26, 2015K143151Cutimed Sorbact Wound Dressings (Cutimed Sorbact Hydroactive, Cutimed Sorbact Hydroactive B, Cutimed Siltec Sorbact)FROSubstantially EquivalentBsn Medical GmbHaccessdata.fda.gov
July 10, 2013K131496BELLAVAR / CUSTOM SEAMLESS SOFT (A.K.A. COMTESSE)DWLSubstantially EquivalentBsn Medical, Inc.accessdata.fda.gov
January 24, 2011K100591SORBACTFROSubstantially EquivalentAbigo Medical ABaccessdata.fda.gov
August 26, 2009K091338COLLASORB COLLAGEN WOUND DRESSINGKGNSubstantially EquivalentHartmann-Conco, Inc.accessdata.fda.gov
April 19, 2007K063059SORBACT WOUND DRESSINGFROSubstantially EquivalentAbigo Medical ABaccessdata.fda.gov
August 20, 1999K991570JOBST READY-TO-WEAR ARM SLEEVESDWLSubstantially EquivalentBeiersdorf-Jobt, Inc.accessdata.fda.gov
May 18, 1995K951234MEDICAL SUPPORT STOCKINGSDWLSubstantially EquivalentJobst A Beiersdorf Co.accessdata.fda.gov

Compare with other makers

Updated August 21, 2017. 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.