Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017297225

FEI Number

3017297225

Entity Name

BSN Medical GmbH

City/State/Country

Hamburg, DE

Establishment Address

Schutzenstrasse 1-3, Hamburg 22761, DE

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

BSN medical GmbH (Owner Number: 9047426)

Owner / Operator Contact Address

Schutzenstrasse 1-3, Hamburg, DE-HH 22761, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

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 Actimove Vertebrace Cervical Collar Actimove Professional Line Cervical Comfort Comfort Cervical Collar Actimove Kids Cervical Cervical Collar 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 Professional Line Rib Belt Two-Panel, For Women Actimove Professional Line Rib Belt Two-Panel, For Men Actimove Professional Line Abdominal Binder Three-Panel Actimove Professional Line Abdominal Binder Comfort Soft Pad Actimove Professional Line Abdominal Binder Four-Panel Cutimed Protect 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 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. 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 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 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 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 No product at the moment 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 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 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 Cutimed Sorbact Ribbon Gauze Cutimed Gel Leukomed Control Actimove Professional Line Cast Shoe Rocker Sole Actimove Professional Line Open Toe Shoe Leukoplast eye occlusor 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2005-11-08
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2005-12-06
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	1999-12-27
IPX	Orthosis, Rib Fracture, Soft	Physical Medicine	Class 1	890.3490	2005-12-05
KTD	Orthosis, Abdominal	Physical Medicine	Class 1	890.3490	2005-12-05
NEC	Bandage, Liquid, Skin Protectant	General Hospital	Class 1	880.5090	2010-09-23
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2013-01-16
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2006-06-30
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2010-07-28
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2005-12-05
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2012-06-01
IPY	Orthosis, Lumbo-Sacral	Physical Medicine	Class 1	890.3490	2021-09-13
ILE	Sling, Arm, Overhead Supported	Physical Medicine	Class 1	890.3475	2019-04-23
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2006-01-19
IOY	Support, Arm	Physical Medicine	Class 1	890.3475	2005-12-05
IQJ	Splint, Clavicle	Physical Medicine	Class 1	890.3490	2005-12-05
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2019-02-06
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2010-08-25
IPG	Shoe, Cast	Physical Medicine	Class 1	890.3025	2024-02-16
HMP	Pad, Eye	General, Plastic Surgery	Class 1	878.4440	2020-01-21
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	1983-12-27

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
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04
K881936	Iberhospitex, S.A.	OPER-FILM-ADHESIVE MEMBRANE	1988-08-31

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0006-2025	Ossur H F Grjothals 5 Reykjavik Iceland	1	Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101
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.
Z-0016-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 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 3017297225. Last updated year: 2026. Please use registration number 3017297225 when referencing this establishment in official correspondence.