Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9710608

FEI Number

3003441980

Entity Name

BSN MEDICAL GMBH

City/State/Country

HAMBURG, DE

Establishment Address

HEYKENAUKAMP 10, HAMBURG D-21147, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),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

K143151

PMA Number

N/A

All Registered Proprietary Names

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 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 Leukomed Sorbact Cutimed Sorbact Swab Cutimed Sorbact Dressing Pad Cutimed Sorbact WCL Cutimed Sorbact Round Swab Cutimed Sorbact Hydroactive Cutimed Siltec Sorbact Cutimed Sorbact Hydroactive B

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2010-07-28
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	1999-12-27
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2010-07-28
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2019-01-29

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
K150256	Argentum Medical	SILVERLON BURN CONTACT DRESSINGS	2015-04-30

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

Similar Registrations

Registration Number	Establishment Name	Location
3027643662	ERIBIOTECH CO.,LTD	Suzhou Jiangsu, CN
3006607005	MOLNLYCKE HEALTH CARE (THAILAND), LTD.	Amphur Muang Chonburi Chon Buri, TH
3015432652	E.L.F. COSMETICS INC	Oakland, CA, US
3043138901	DONGGUAN SAMVO BIOTECHNOLOGY CO., LTD	Dongguan Guangdong, CN
3015215566	THE HAIN CELESTIAL GROUP	Hoboken, NJ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9710608. Last updated year: 2026. Please use registration number 9710608 when referencing this establishment in official correspondence.