Essity Distribution B.V.

FDA Device Registration & Listing · GE Oostrum Fryslan, NL · Registration 3017633586

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3017633586
FEI Number
3017633586
Entity Name
Essity Distribution B.V.
City/State/Country
GE Oostrum Fryslan, NL
Establishment Address
c/o CEVA Logistics Netherlands B.V., Bellstraat 20, GE Oostrum Fryslan 5807, NL
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
BSN medical GmbH (Owner Number: 9047426)
Owner / Operator Contact Address
Schutzenstrasse 1-3, Hamburg, DE-HH 22761, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Cutimed Sorbion Sorbact Actimove Professional Line Clavicula Clavicle Support Actimove Professional Line Cervical Cervical Collar Soft Density Regular Width Actimove Professional Line Cervical Cervical Collar Soft Density Narrow Width No product at the moment Leukoplast eye occlusor Comprifoam Jobst Foam Compri 2 Padding Layer Tensogrip FARROWFOAM ICE-08-01 Reusable Ice Bag for Ankle Orthosis ICE-04-01 - Reusable Ice Bag for Knee Orthosis GP-KN-01 - Knee Orthosis Reusable Cold Pack PowerPlay - GP-360-01 Gel Pack for PPKN-360 Knee Wrap BSN Hot-Cold Pack ICE-05-01 - Reusable Ice Bag for Shoulder Orthosis GP-AN-01 - Ankle Orthosis Reusable Gel Pack GP-SH-01 - Shoulder Orthosis Reusable Cold Pack GP-AN-01T - Ankle Orthosis Resuable Gel Pack (Tongue Accessory) Leukomed T plus Leukomed T plus skin sensitive Leukomed T Leukomed I.V. Film Cuticell Contact Leukomed Leukomed T skin sensitive Leukomed Skin Sensitive Leukoplast Elastic Leukoplast kids hero edition Leukoplast aqua pro Leukoplast strong Leukoplast soft white Cutimed Cuticell Leukoplast kids Leukoplast barrier Leukomed I.V. JOBST Maternity OPAQUE JOBST Confidence JOBST Mens Dress JOBST Sensifoot JOBST Style JOBST forMen JOBST Activa SoSoft Cutimed Gel Leukomed Control Cutimed Protect PowerPlay - PPSH-59 Universal Shoulder Orthosis PowerPlay - PPWR-68U Universal Wrist Orthosis PowerPlay - PPEL-22 Universal Elbow Orthosis PowerPlay - PPBB-SBP Cold and Compression Back Wrap with One Gel Pack Actimove Professional Line PowerMotion Calf support Actimove Sports Edition Thigh Support Adjustable Actimove Sports Edition Shoulder Support Extra Pocket for Optional Hot/Cold Pack Actimove Professional Line PowerMotion Thigh support PowerPlay - PPKN-58 Cold and Compression Knee Wrap PowerPlay - PPHP-65 Universal Hip Orthosis PowerPlay - PPKN-360 Circumferential Knee Orthosis PowerPlay - PPBB-LBP Cold and Compression Back Wrap with One Gel Pack PowerPlay - PPBB-SP Cold and Compression Back Wrap with One Gel Pack PowerPlay - PPAN-66 Universal Ankle Orthosis PowerPlay - PPFL-27 Full Leg Cold and Compression Wrap PowerPlay - Cold Compression ROM Knee Brace with One Gel Pack DELTA DRY Softliner Delta Terry-Net Adhesive Felt Liner Delta-Rol Synthetic Padding Jersey Stockinette Delta-Lite Conformable Delta-Cast Elite Gelocast Elastic Specialist Splint Soffban Padding CAST BANDAGES (MULTIPLE BRANDS) Specialist 100 Cotton Padding SafetySplint Delta-Lite Plus Gypsona HP POP FlashCast Elite Orthoflex Elastic POP Gelostretch CAST (MULTIPLE BRANDS) Delta Terry-Net Loop Closures Delta-Cast Conformable Delta-Cast Soft ELASTOMULL Delta-Net Stockinette Gypsona Terry-Net S Stockinette OCL splint Roll DELTA DRY Stockinette Sof-Rol Synthetic Padding Ortho-Glass OCL POP CAST PADDING (MULTIPLE BRANDS) FlashCast Fiberglass Cast Tape Specialist Stockinette Delta Terry-Net Fleece Edger DELTA DRY Dynacast Prelude Specialist Cotton Blend Padding Ortho-Form Jersey Cotton Stockinette Terry-Net Thumb Spica Stockinette Specialist POP Terry-Net C Stockinette Delta-Cast Prints FlashCast Plaster of Paris Delta Terry-Net Padding Dynacast Ankle Splint Delta Dry Pantaloon Delta-Dry Padding Gypsona S POP Gelocast Specialist 100 Cotton Padding Sterile Dynacast Ankle Splint Kit Specialist Cotton Blend Padding Sterile Sof-Rol Synthetic Padding Sterile Delta-Rol Synthetic Padding Sterile Aquacast Liner Hipster Pantaloon Liner Isoband Tricofix Dynacast S Artiflex Jobst Comprifore #3 LF Elastomull Jobst Comprilan Jobst Comprifore #1 Jobst Compri2 Tensoshape Tensogrip Co-Plus LF by Actimove Jobst Comprifore Lite LF , Jobst Comprifore #2 Jobst Comprifore #4 LF Jobst Comprifore LF Jobst Compri2 Lite PressureLite Diabetic Socks PressureLite Super Socks Comprinet forte Liner No-Varix JOBST Sensifoot Custom Seamless Soft Bellavar Cutimed Sorbion Sachet XL Cutimed Hydro L Cutimed Sorbion Sana Gentle Cutimed Siltec PLUS Heel Cutimed Sorbion Sachet S Cutimed Cavity Cutimed Hydro B Cutimed Siltec L Cutimed Sorbion Multi-Star Cutimed Siltec Sacrum Cutimed Sorbion Sachet S Drainage Cutimed Siltec B Cutimed Siltec Heel (3D) Cutimed Siltec PLUS Cutimed Siltec Cutimed Sorbion Border Cutimed Sorbion Carbon+ Cutimed Sorbion Sana Multi Start Actimove Professional Line Cast Shoe Rocker Sole Actimove Professional Line Open Toe Shoe JOBST BELLA STRONG GAUNTLET JOBST Armsleeves JOBST BELLA LITE GAUNTLET JOBST BELLA LITE ARMSLEEVE JOBST BELLA STRONG ARMSLEEVE JOBST BELLA LITE COMBINED JOBST Anti-Em GP JOBST ACTIVEWEAR JOBST Comprinet S JOBST ATHLETIC JOBST Comprinet Forte JOBST FOR MEN JOBST CASUAL PATTERN JOBST OPAQUE JOBST ULTRASHEER JOBST SOSOFT JOBST Anti-Embolism JOBST ULCERCARE JOBST TRAVEL SOCKS JOBST RELIEF JOBST Comprinet pro JOBST FOR MEN AMBITION JOBST SPORT JOBST FOR MEN CASUAL Activa Actimove Professional Line TaloCast Ankle Brace Actimove Professional Line AchilloMotion Achilles Tendon Support Actimove Sports Edition Wrist Support Elastic Wrap Around Actimove Sports Edition Ankle Support Actimove Kids Ankle Support Actimove Professional Line Talocast Actimove Sports Edition Ankle Support, Adjustable Actimove Professional Line TaloMotion Ankle Support Actimove Professional Line Closed Shell Air Walker Ankle Walker Actimove Everyday Supports Mild Ankle Support Actimove Sports Edition Ankle Stabilizer Criss-Cross Straps Actimove Closed Shell Air Walker Actimove Everyday Supports Ankle Support Actimove Arthritis Care Ankle Support Actimove Professional Line TaloBrace Comfort Ankle Brace Actimove Professional Line TaloCast Air Ankle Brace Actimove Professional Line TaloBrace Air Comfort Ankle Brace Actimove Professional Line TaloCast AirGel Ankle Brace Actimove Vertebrace Cervical Collar Actimove Professional Line Cervical Comfort Comfort Cervical Collar Actimove Kids Cervical Cervical Collar Therall Body Warmer Jobst Comprifore Jobst Comprifore LF Jobst Comprifore lite Jobst Comprifore lite LF CELLACAST SPLINT ROLL EMTECH ORTHO-GLASS ENDURE-SPLINT OCL CONTOUR - SINGLE Actimove Kids Mitella Arm Sling Actimove Professional Line Sling Comfort Arm Sling - Dispenser Box Actimove Professional Line Umerus Shoulder Immobilizer Actimove Professional Line Mitella Comfort Comfort Arm Sling Actimove Professional Line Sling and Swathe Shoulder Immobilizer Actimove Professional Line Shoulder Abduction Sling Shoulder Immobilizer Actimove Professional Line Y-Tab for Sling Comfort Actimove Professional Line Umerus Comfort Comfort Shoulder Immobilizer Actimove Profesional Line Arm Sling Actimove Professional Line Sling Comfort Arm Sling – Single Pack Actimove Professional Line Sling Arm Sling - On a Roll Actimove Professional Line Mitella Arm Sling Cutimed Epiona FREEMAN ABDOMINOPLASTY CROW AND GARTER BELTS Cutimed Sorbact Ribbon Gauze ACTIMOVE SOLEA ACTIMOVE KIDS ELBOW SUPPORT, ADJUSTABLE Actimove Professional Line EpiMotion Elbow Support Actimove Arthritis Care Elbow Support Actimove Sports Edition Elbow Support Adjustable Actimove Everyday Supports Elbow Support Pressure Pads,Strap Actimove Sports Edition Elbow Strap (Hot/Cold Pack) Actimove Everyday Supports Mild Elbow Support Actimove Professional Line EpiSport Elbow Clasp, Adjustable Actimove Everyday Supports Elbow Support Surgical Vest Bellisse Actimove Professional Line Abdominal Binder Three-Panel Actimove Professional Line Abdominal Binder Comfort Soft Pad Actimove Professional Line Abdominal Binder Four-Panel Actimove Professional Line Rhizo Forte Thumb Orthosis Actimove Professional Line Manus Forte Wrist Brace Actimove Sports Edition Wrist Stabilizer epimotion Metal Stay Left or Right Actimove Professional Line Gauntlet Wrist and Thumb Stabilizer Actimove Alufoam Actimove Arthritis Care Arthritis Gloves ACTIMOVE PROFESSIONAL LINE MANUS, WRIST STABILIZER Actimove Everyday Supports Wrist Stabilizer Carpal Pre-shaped Metal Stay Actimove Arthritis Care Wrist Support ACTIMOVE KIDS WRIST STABILIZER, REMOVABLE METAL STAY, LEFT OR RIGHT Actimove Sports Edition Thumb Stabilizer Extra Stays Actimove Sports Edition Wrist Support Adjustable Actimove Professional Line Manus Forte Plus Wrist & Thumb Brace Actimove Professional Line Manus Air Stabilizing Fracture Wrist Brace Actimove Sports Edition Wrist Support Elastic Wrap Around Actimove Professional Line Wrist Brace Suede Finish, Lace-Closure Actimove Professional Line Wrist Splint 6" Actimove Professional Line Wrist Splint, Abducted Thumb, Compression-Formed Composite Actimove Professional Line Wrist Splint 8" Actimove Professional Line ManuMotion Wrist Support Actimove Professional Line Thumb Spica Soft Fit Thumb and Wrist Brace Actimove Professional Line Manus Wrist Stabilizer Child Walking Heel Specialist Post-Op Shoe Deluxe Rigid Post-Op Shoe Vinyl Molded Sole Rocker Cast Shoe ECO Cast Shoe Adult Walking Heel Pediatric Print Cast Shoe Canvas Molded Sole Rocker Deluxe Flexible Sole Healing Shoe Walking Heel Pedestal Open Toe Cast Shoe Dynasol Cast Shoe Super Post-Op Shoe Walking Heel Cushioned Tread Cast Thumb Ring Dynacast Prelude Strap Kits Delta-Xpress Saw Stop Protective Strip Saw Stop Ultra Protective Strip TENSOGRIP

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FRO Dressing, Wound, Drug Unknown Class U N/A 2016-12-05
IQJ Splint, Clavicle Physical Medicine Class 1 890.3490 2005-12-05
ILE Sling, Arm, Overhead Supported Physical Medicine Class 1 890.3475 2019-04-23
HMP Pad, Eye General, Plastic Surgery Class 1 878.4440 2020-01-21
FMP Protector, Skin Pressure General Hospital Class 1 880.6450 2005-12-05
IME Pack, Hot Or Cold, Reusable Physical Medicine Class 1 890.5700 2012-01-06
NAD Dressing, Wound, Occlusive General, Plastic Surgery Class 1 878.4020 2006-06-30
DWL Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) General Hospital Class 2 880.5780 2019-12-19
NAE Dressing, Wound, Hydrogel Without Drug And/Or Biologic General, Plastic Surgery Class 1 878.4022 2010-08-25
NEC Bandage, Liquid, Skin Protectant General Hospital Class 1 880.5090 2010-09-23
IQI Orthosis, Limb Brace Physical Medicine Class 1 890.3475 2006-01-19
ITG Bandage, Cast Physical Medicine Class 1 890.3025 2007-04-11
FQM Bandage, Elastic General Hospital Class 1 880.5075 2005-11-08
FQL Stocking, Medical Support (For General Medical Purposes) General Hospital Class 1 880.5780 1992-11-21
DWL Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) General Hospital Class 2 880.5780 2015-02-02
NAC Dressing, Wound, Hydrophilic General, Plastic Surgery Class 1 878.4018 2010-07-28
IPG Shoe, Cast Physical Medicine Class 1 890.3025 2024-02-16
DWL Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) General Hospital Class 2 880.5780 2015-08-19
DWL Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) General Hospital Class 2 880.5780 2007-11-28
ITW Joint, Ankle, External Brace Physical Medicine Class 1 890.3475 2012-06-01
IQK Orthosis, Cervical Physical Medicine Class 1 890.3490 2005-12-06
IMD Pack, Hot Or Cold, Disposable Physical Medicine Class 1 890.5710 2010-01-25
PYK Venous Ulcer Kit General, Plastic Surgery Class 1 878.4014 2022-07-29
FYH Splint, Extremity, Noninflatable, External, Sterile General, Plastic Surgery Class 1 878.3910 1995-03-02
ILI Sling, Arm Physical Medicine Class 1 890.3640 2013-01-16
KGN Wound Dressing With Animal-Derived Material(S) Unknown Class U N/A 2015-06-01
FSD Binder, Abdominal General Hospital Class 1 880.5160 2001-09-28
FRO Dressing, Wound, Drug Unknown Class U N/A 2019-02-06
KNP Orthosis, Corrective Shoe Physical Medicine Class 1 890.3475 2005-12-05
IOY Support, Arm Physical Medicine Class 1 890.3475 2005-12-05
HEF Binder, Breast General Hospital Class 1 880.5160 1992-11-21
KTD Orthosis, Abdominal Physical Medicine Class 1 890.3490 2005-12-05
ILH Splint, Hand, And Components Physical Medicine Class 1 890.3475 1983-12-27
LGF Component, Cast Orthopedic Class 1 888.5940 2006-01-19
IPM Cover, Limb Physical Medicine Class 1 890.3025 2006-01-19

Official Correspondent

No official correspondent registered.

US Agent Details

Sean Anderson Email: RegistrationTeamCLT@essity.com Phone: (959) 5997401

Related Public Records

Same Entity

BSN medical GmbH
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
9615780 BSN MEDICAL VIBRAYE Sarthe, FR
1043537 BSN medical inc. Hickory, NC, US
8043565 BSN-JOBST GMBH EMMERICH North Rhine-Westphalia, DE
1038963 BSN MEDICAL, INC. CHARLOTTE, NC, US
9617266 BSN medical Limitada (COLOMBIA) CALI Valle del Cauca, CO

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K150256 Argentum Medical SILVERLON BURN CONTACT DRESSINGS 2015-04-30
K881936 Iberhospitex, S.A. OPER-FILM-ADHESIVE MEMBRANE 1988-08-31
K880871 John Wagner Associates, Inc. GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER 1988-05-20
K112888 Kensey Nash Corporation MESO WOUND MATRIX 2012-02-10
K040211 Collagen Matrix, Inc. MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING 2004-02-27

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0003-06 B. Braun Medical, Inc. U
D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025 3M Company Health Care Business 3m Center U
3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R
Z-0013-2019 COVIDIEN LLC 1
Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.
Z-0014-2019 COVIDIEN LLC 1
Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0015-2019 COVIDIEN LLC 1
Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017633586. Last updated year: 2026. Please use registration number 3017633586 when referencing this establishment in official correspondence.
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