Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9617266

FEI Number

3002249650

Entity Name

BSN medical Limitada (COLOMBIA)

City/State/Country

CALI Valle del Cauca, CO

Establishment Address

CRA. 36 NO. 13-451, CALI Valle del Cauca --, CO

Establishment Type(s)

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

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. PressureLite Diabetic Socks PressureLite Super Socks Comprinet forte Liner No-Varix JOBST Sensifoot Leukoplast eye occlusor

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2006-06-30
FQL	Stocking, Medical Support (For General Medical Purposes)	General Hospital	Class 1	880.5780	1992-11-21
HMP	Pad, Eye	General, Plastic Surgery	Class 1	878.4440	2020-01-21

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
9710608	BSN MEDICAL GMBH	HAMBURG, DE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K881936	Iberhospitex, S.A.	OPER-FILM-ADHESIVE MEMBRANE	1988-08-31

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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.
Z-0017-2019	COVIDIEN LLC	1	Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103 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 9617266. Last updated year: 2026. Please use registration number 9617266 when referencing this establishment in official correspondence.