Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005694677

FEI Number

3005694677

Entity Name

B. Braun Medical S.A.

City/State/Country

Crissier Vaud, CH

Establishment Address

Route de la Sorge 9, Crissier Vaud CH-1023, CH

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

B. BRAUN MELSUNGEN AG (Owner Number: 8010484)

Owner / Operator Contact Address

CARL-BRAUN-STR.1, --, MELSUNGEN, DE-NOTA 34212, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Prontosan

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KDN	System, Perfusion, Kidney	Gastroenterology, Urology	Class 2	876.5880	2018-11-27
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2014-12-22

Official Correspondent

Kamaal Anas

US Agent Details

Kamaal Anas Business: B. Braun Medical Inc Email: kamaal.anas@bbraunusa.com Phone: (484) 5231349

Related Public Records

Same Entity

B. BRAUN MELSUNGEN AG

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9680474	B. BRAUN MEDICAL, LTD.	GYONGYOS Heves, HU
3007120504	B. Braun Medical AG	Sempach Luzern, CH
9680591	B. BRAUN AESCULAP JAPAN CO., LTD.	TOCHIGI, JP
8031007	B. BRAUN MEDICAL AG	ESCHOLZMATT Luzern, CH
9610825	B. BRAUN MELSUNGEN AG	MELSUNGEN Hesse, DE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K013575	Organ Recovery Systems, Inc.	KPS-I, THE KIDNEY PERFUSION SOLUTION	2002-01-25
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

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3024820181	INSTITUT GEORGES LOPEZ	ST LAURENT DE CHAMOUSSET Rhone, FR
1067143	BIOCURE SOLUTIONS, LLC DBA BIOCURE, INC.	Peachtree Corners, GA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005694677. Last updated year: 2026. Please use registration number 3005694677 when referencing this establishment in official correspondence.