Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9680787

FEI Number

3002826093

Entity Name

HENNIG ENTERPRISES EUROPE S.R.L.

City/State/Country

IASI, RO

Establishment Address

B-DUL POITIERS 14, IASI 700671, RO

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

HENNIG ENTERPRISES EUROPE S.R.L. (Owner Number: 9011425)

Owner / Operator Contact Address

B-DUL POITIER 14, --, IASI, RO-NOTA 700671, RO

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Patient Controlled Analgesic Device O'Neil Sterile Field Urinary Catheter Catheter Kit Amnicot

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MEB	Pump, Infusion, Elastomeric	General Hospital	Class 2	880.5725	2008-02-03
KNY	Accessories, Catheter, G-U	Gastroenterology, Urology	Class 2	876.5130	2008-02-03
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2008-02-03
FCM	Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)	Gastroenterology, Urology	Class 2	876.5130	2008-02-03
HGE	Amniotome	Obstetrics/Gynecology	Class 1	884.4530	2008-02-03

Official Correspondent

No official correspondent registered.

US Agent Details

Amanda SINGLETON Business: Compliance Systems International, LLc. Email: amanda.compliance.sys.intl@gmail.com Phone: (716) 4407364

Related Public Records

Same Entity

HENNIG ENTERPRISES EUROPE S.R.L.

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
K873288	Todd Medical, Inc.	CLOSED FOLEY CATHETER SYSTEM	1987-11-27
K912919	Mentor Corp.	MENTOR INFUSION LINE	1991-12-13
K033719	C.R. Bard, Inc.	BARD TIGERTAIL URETERAL CATHETER	2004-02-04
K820239	American Endoscopy, Inc.	RETRIEVAL FORCEPS	1982-03-26
K041243	Tyco Healthcare	DOVER RED RUBBER ROBINSON CATHETER	2004-07-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2013	C.R. Bard, Inc., Urological Division	2	8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc balloon. The product is packaged individually with 12 units per corrugated case. The product is sold sterile for single use and is used to provide continuous urinary drainage from the bladder.

Similar Registrations

Registration Number	Establishment Name	Location
3007008418	FIRST MEDICAL SOURCE, LLC	Laguna Beach, CA, US
9680425	Avent S. de R.L. de C.V.	TIJUANA Baja California, MX
2029275	Sterigenics U.S., LLC	Corona, CA, US
3012429465	Epic International (Thailand) Co., Ltd.	Pluak Daeng Rayong, TH
2030624	Isomedix Operations, Inc.	Temecula, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9680787. Last updated year: 2026. Please use registration number 9680787 when referencing this establishment in official correspondence.