FDA Registration
Active
🇳🇱 Netherlands
Essity Distribution B.V.
Reg #: 3017633586
·
FEI: 3017633586
·
Expires 2026
Products
44
Proprietary Names
439
Establishment Types
1
Classifications
44
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Registration Details
- Registration Name
- Essity Distribution B.V.
- Registration Number
- 3017633586
- FEI Number
- 3017633586
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- c/o CEVA Logistics Netherlands B.V., Bellstraat 20
- City
- GE Oostrum Fryslan
- Country
- NL
Regulatory Submissions
- 510(k) Number
- K153674
Owner / Operator
- Firm Name
- BSN medical GmbH
- Operator Number
- 9047426
- Address
- Schutzenstrasse 1-3
- City
- Hamburg
- State
- DE-HH
- Postal Code
- 22761
- Country
- DE
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2016-12-05 |
| Splint, Clavicle | IQJ | Class 1 | Physical Medicine | No | 2005-12-05 |
| Sling, Arm, Overhead Supported | ILE | Class 1 | Physical Medicine | No | 2019-04-23 |
| Pad, Eye | HMP | Class 1 | General, Plastic Surgery | No | 2020-01-21 |
| Protector, Skin Pressure | FMP | Class 1 | General Hospital | No | 2005-12-05 |
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 2012-01-06 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2006-06-30 |
| Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) | DWL | Class 2 | General Hospital | No | 2019-12-19 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | Class 1 | General, Plastic Surgery | No | 2010-08-25 |
| Bandage, Liquid, Skin Protectant | NEC | Class 1 | General Hospital | No | 2010-09-23 |
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2006-01-19 |
| Bandage, Cast | ITG | Class 1 | Physical Medicine | No | 2007-04-11 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2005-11-08 |
| Stocking, Medical Support (For General Medical Purposes) | FQL | Class 1 | General Hospital | No | 1992-11-21 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2010-07-28 |
| Shoe, Cast | IPG | Class 1 | Physical Medicine | No | 2024-02-16 |
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 2012-06-01 |
| Orthosis, Cervical | IQK | Class 1 | Physical Medicine | No | 2005-12-06 |
| Pack, Hot Or Cold, Disposable | IMD | Class 1 | Physical Medicine | No | 2010-01-25 |
| Venous Ulcer Kit | PYK | Class 1 | General, Plastic Surgery | No | 2022-07-29 |
| Splint, Extremity, Noninflatable, External, Sterile | FYH | Class 1 | General, Plastic Surgery | No | 1995-03-02 |
| Sling, Arm | ILI | Class 1 | Physical Medicine | No | 2013-01-16 |
| Wound Dressing With Animal-Derived Material(S) | KGN | Class U | Unknown | No | 2015-06-01 |
| Binder, Abdominal | FSD | Class 1 | General Hospital | No | 2001-09-28 |
| Orthosis, Corrective Shoe | KNP | Class 1 | Physical Medicine | No | 2005-12-05 |
| Support, Arm | IOY | Class 1 | Physical Medicine | No | 2005-12-05 |
| Binder, Breast | HEF | Class 1 | General Hospital | No | 1992-11-21 |
| Orthosis, Abdominal | KTD | Class 1 | Physical Medicine | No | 2005-12-05 |
| Splint, Hand, And Components | ILH | Class 1 | Physical Medicine | No | 1983-12-27 |
| Component, Cast | LGF | Class 1 | Orthopedic | No | 2006-01-19 |
| Cover, Limb | IPM | Class 1 | Physical Medicine | No | 2006-01-19 |
| Binder, Medical, Therapeutic | MDR | Class 1 | General Hospital | No | 2003-04-14 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 1999-12-27 |
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 2005-12-05 |
| Orthosis, Truncal/Orthosis, Limb | MRI | Class 1 | Physical Medicine | No | 2005-12-05 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2006-07-25 |
| Orthosis, Lumbar | IQE | Class 1 | Physical Medicine | No | 2005-12-05 |
| Band Or Belt, Pelvic Support | ISR | Class 1 | Physical Medicine | No | 2019-12-16 |
| Splint, Extremity, Non-Inflatable, External, Non-Sterile | NOC | Class 1 | General, Plastic Surgery | No | 2007-01-23 |
| Instrument, Cast Application/Removal, Manual | LGG | Class 1 | Orthopedic | No | 2006-02-17 |
| Cover, Cast | KIA | Class 1 | General Hospital | No | 2012-01-06 |
| Orthosis, Rib Fracture, Soft | IPX | Class 1 | Physical Medicine | No | 2005-12-05 |
| Aid, Transfer | IKX | Class 1 | Physical Medicine | No | 2012-02-02 |
| Orthosis, Lumbo-Sacral | IPY | Class 1 | Physical Medicine | No | 2021-09-13 |
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
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
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 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 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
Leukomed Sorbact
Cutimed Sorbact Swab
Cutimed Sorbact Dressing Pad
Cutimed Sorbact WCL
Cutimed Sorbact Round Swab
Safe-T-Sport Neoprene Shoulder Support
FarrowWrap Classic Arm
Farrow Toe Cap
Farrow Glove
FarrowWrap Basic Leg Foot
Epstein Facioplasty
FarrowWrap Short Stretch
FarrowHybrid ADI Foot Compression
FarrowWrap Lite Arm
FarrowWrap Strong Leg Foot Thigh Knee
FarrowWrap Lite Gauntlet
Shoulder Abduction Support
FarrowWrap 4000
Posture Control Shoulder
JOBST Bella Lite Glove
FarrowWrap Lite Leg Foot Thigh Knee
FarrowWrap Liner
JOBST Relax
JOBST Bella Strong Glove
FarrowWrap Replacement
JOBST Plastic Surgery Girdle
JOBST Facioplasty Elastic Support
FarrowWrap Terry Cloth Liner
Farrow Garment Grip
JOBST JoViPak Vest
FarrowWrap Velcro Pack
JOBST JoViJacket Shoulder
FLA Muscle Support
FarrowWrap Classic Leg Foot Thigh
FarrowWrap Strong Arm
JOBST JoViPak Boxer
JOBST JoViJacket Busti
JOBST JoViPad Multipurpose
JOBST JoViJacket Vest
JOBST JoViJacket Arm MTM
JOBST JoViPak Arm MTM
JOBST JoViPad Eye
JOBST JoViPad Genital
JOBST JoViPak Leg MTM
JOBST JoViJacket Leg MTM
JOBST JoViPak Shoulder
JOBST JoViPak Leg RTW
JOBST JoViJacket Hip Hugger
JOBST JoViPak Chin Strap
JOBST JoViPak Busti
JOBST JoViPad Neck
JOBST JoViJacket Boxer
JOBST JoViJacket Leg RTW
JOBST JoViPak Arm RTW
JOBST JoViPad Breast and Chest
JOBST JoViPak Face Mask
JOBST JoViJacket Arm RTW
JOBST JoViLiner Leg
JOBST JoViLiner Arm
Actimove Everyday Supports Posture Control Brace
Hypafix transparent
Tensoplast LF by Actimove
Cover-Roll stretch
Hypafix skin sensitive
Tensosport
Hypafix
ELASTOPLAST
LEUKOPLAST
Leukotape K
Fixomull Transparent / Leukoplast Fixomull Transparent
Elastikon by Actimove
Lightplast Pro
Zonas
Coach
Leukotape P by Actimove
Tensospray by Actimove
Actimove Everyday Supports Knee Support Open Patella, 4 Stays
Actimove Sports Edition Patella Strap Adjustable
Actimove Sports Edition Knee Brace Wrap Around Simple Hinges Condyle Pads
Actimove Sports Edition Knee Support Open Patella, Adjustable
Actimove Professional Line Genu Eco Knee Immobilizer
Actimove Sports Edition Knee Brace Adjustable Horseshoe Simple Hinges Condyle Pads
Actimove Everyday Supports Mild Knee Support
Actimove Arthritis Care Knee Support
Actimove Kids Knee Support Open Patella
Actimove Sports Edition Knee Support Open Patella
Actimove Everyday Supports Knee Support Closed Patella, 2 Stays
Actimove Professional Line Genu Tri-Panel Knee Immobilizer
Actimove Sports Edition Knee Brace Wrap Around Polycentric Hinges Condyle Pads
Actimove Everyday Supports Knee Support Closed Patella
Actimove Professional Line GenuMotion Knee Support
Actimove Sports Edition Knee Support Closed Patella
Actimove Sports Edition Dual Knee Strap Adjustable
Actimove Sports Edition Knee Stabilizer Adjustable Horseshoe and Stays
Actimove Sports Edition PF Knee Brace Lateral Support J-Shaped Buttress Simple Hinges, Condyle Pads
Actimove Professional Line Genu Clips
Actimove Professional Line Knee Brace, Composite Polycentric Hinges
Actimove Professional Line HealWell Cub Plantar Fasciitis Night Splint Resting Comfort Slipper
Actimove Professional Line Genu Eco/Genu Clips Extension Tab
Actimove Professional Line Knee Immobilizer Tri-Panel
ACTIMOVE POST-OP ROM KNEE BRACE
ACTIMOVE
Cutisoft Cotton
PROPAX
Fivex
Cutimed Sorbact Hydroactive
Cutimed Siltec Sorbact
Cutimed Sorbact Hydroactive B
Actimove Everyday Supports Back Support High-Density Foam Panel Adjustable Double Layer Compression
Actimove Sports Edition Back Support, 4 Stays, Adjustable Double Layer Compression
Safe-T-Lift DX
Actimove Sports Edition Back Stabilizer Rigid Panel with Pressure Pads SMART Easy-Closing-Pulley-System
Safe-T-Belt Working Lumbar Belt
Actimove Professional Line LO-PLUS Lumbar Support, Stabilizing Posterior Panel
Actimove Professional Line LumbaMotion Back Support with Pressure Pad
Actimove Professional Line LumbaMotion Lady Back Support with Pressure Pad
JOBST MATERNITY SUPPORT BELT
Delta Thermo Orthoplast Boot
Delta Thermo Memory
Delta Thermo Thumb
Delta Thermo Knee
Delta Thermo Orthoplast Corset
Delta Thermo Wrist
Delta Thermo Elbow
Delta Thermo Hand/Wrist
Delta-Xpress Wrist
Delta-Xpress Hand
Delta-Xpress Elbow
Delta-Xpress Lower Leg
Orthoglass Scissors
Esmarch Scissors
Improved Cast Spreader
FCT Scissors
Bohler Serrated Scissors
Utility Scissors
Clean Cut Scissors
Henning Plaster Spreader
Zip Stick
BSN Cast Protector
Actimove Professional Line Cast Protector
Actimove Professional Line Rib Belt Two-Panel, For Women
Actimove Professional Line Rib Belt Two-Panel, For Men
JOBST Donning Aid
JOBST Stocking Donner
Actimove Professional Line Lumbar Sacral Support
Actimove Professional Line Lumbar Sacral Support Comfort Additional Support Belt, Pressure Pad
Actimove Professional Line Deluxe Lumbar Sacral Support Rigid Panel, for Women
Actimove Professional Line Lumbar Sacral Support Comfort Additional Support Belt
Actimove Everyday Supports Lumbar Sacral Support
Cutimed Sorbact Gel Dressing
Establishment Types
Export Device to the United States But Perform No Other Operation on Device