Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8043838

FEI Number

3004728227

Entity Name

LABORATOIRES BROTHIER, S.A.

City/State/Country

FONTEVRAUD L ABBAYE Maine-et-Loire, FR

Establishment Address

ZONE ARTISANALE-B.P. 26, FONTEVRAUD L ABBAYE Maine-et-Loire F-49590, FR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

LABORATOIRES BROTHIER, S.A. (Owner Number: 9004082)

Owner / Operator Contact Address

41 RUE DE NEUILLY, --, NANTERRE, FR-NOTA 92735, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K102742

PMA Number

N/A

All Registered Proprietary Names

ENTAXIS NASAL PACKING NasalCEASE and BleedCEASE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EMX	Balloon, Epistaxis	Ear, Nose, Throat	Class 1	874.4100	1999-03-26
QSY	Hemostatic Wound Dressing Without Thrombin Or Other Biologics	Unknown	Class U	N/A	2018-11-23

Official Correspondent

No official correspondent registered.

US Agent Details

Bruce Ford Business: CAREnCEASE Healthcare LLC Email: Brmaford@aol.com Phone: (585) 7814468

Related Public Records

Same Entity

LABORATOIRES BROTHIER, S.A.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K220566	Koag, LLC	Vascette HP (hemostatic pad)	2022-07-29
K080818	Hem Con Medical Technologies, Inc.	HEMCON BANDAGE, HEMCON BANDAGE OTC, HEMCON CHITOFLEX-SURGICAL DRESSING	2008-05-15
K893123	Les Laboratorires Brothier, S.A.	ADHESIVE BANDAGES & PADS FOR MINOR CUTS/SCRAPES	1990-02-13
K143462	Benq Materials Corporation	AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze (over-the-counter use)	2015-05-08
K040208	Tz Medical, Inc.	NEPTUNE PAD, NEPTUNE DISC, NEPTUNE COMFORT-BAND, COMFORT-BAND	2004-05-11

Similar Registrations

Registration Number	Establishment Name	Location
3007225047	HEMOSTASIS, LLC	Saint Paul, MN, US
1423662	Sterigenics US LLC	Gurnee, IL, US
1450662	Isomedix Operations, Inc.	Libertyville, IL, US
8043396	SHENZHEN JPY ION-TECH. CO., LTD.	Shenzhen Guangdong, CN
3014656749	RHENUS SE & CO. KG	Holzwickede North Rhine-Westphalia, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8043838. Last updated year: 2026. Please use registration number 8043838 when referencing this establishment in official correspondence.