Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9615780

FEI Number

3003747474

Entity Name

BSN MEDICAL

City/State/Country

VIBRAYE Sarthe, FR

Establishment Address

1 Rue Du Millenaire, B.P. 22, VIBRAYE Sarthe 72320, FR

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

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

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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	1999-12-27

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
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
9710608	BSN MEDICAL GMBH	HAMBURG, DE

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

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3012453673	FANNIN (UK) LIMITED	Measham, Swadlincote Derbyshire, GB
3019843433	The Natural Patch Company Pty Ltd	Prahran Victoria, AU

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9615780. Last updated year: 2026. Please use registration number 9615780 when referencing this establishment in official correspondence.