Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3031571464

FEI Number

3031571464

Entity Name

Herotron E-Beam Service GmbH

City/State/Country

Bitterfeld Saxony-Anhalt, DE

Establishment Address

Guardianstrabe 6-10, Bitterfeld Saxony-Anhalt 06766, DE

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

STERIS Corporation (Owner Number: 10042227)

Owner / Operator Contact Address

5960 Heisley Road, Mentor, OH 44060, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Hollister (BT) - Vapro Plus Hollister (BT) - Vapro Plus Pocket Hollister (TL) - VaPro Pocket

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EZD	Catheter, Straight	Gastroenterology, Urology	Class 2	876.5130	2024-05-24
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2025-02-10

Official Correspondent

No official correspondent registered.

US Agent Details

Becky L Aldhizer Business: STERIS CORPORATION Email: becky_aldhizer@steris.com Phone: (440) 4687462

Related Public Records

Same Entity

STERIS Corporation

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3018811167	MEDIVATORS INC	Rogers, MN, US
3038285067	Synergy Sterilisation Kulim (M) Sdn. Bhd	Seberang Perai Selatan Pulau Pinang, MY
3010897183	Synergy Health Marseille SAS	CHUSCLAN Gard, FR
3008252486	ELECTRON BEAM SDN BHD	Port Klang Selangor, MY
3017616393	STERIS TOMOE (Thailand) Ltd.	Chonburi Chon Buri, TH

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K981246	Integra Neurocare, LLC	BEVERLY REFERENTIAL VALVE (NL850-9710) WITH INTEGRAL PERITONEAL CATHETER (NL850-9720) VALVE KIT (NL850-9730)	1999-05-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0004-2013	Cure Medical LLC	2	Male, 16Fr, Straight-tip Intermittent Urinary Catheters M16. The product is distributed individually or in intermediate boxes containing 30 individual, sterile packaged catheters (PA/PE film and dialyzing paper pouches). There are 30 catheters packaged in sterile pouches that are placed into an intermediate box, 10 of these intermediate boxes packaged into one case. K072539 The Cure Catheter" device, M16, is an intermittent urinary catheter intended to be used by males for the purpose of bladder drainage. It is manufactured with conventional medical grade, latex-free, biocompatible materials. The straight-tip has been designed to eliminate trauma to the urethra and is provided in 16Fr size in an easy-to-open, sterile, single-use package. The coud-tip catheter, M16C, is designed with a curved tip that makes it easier to pass through the curvature of the prostatic urethra in men. It is also used to pass through urethral strictures. This product is prescribed for people who have difficulty or are unable to pass a straight catheter through their urethra and into their bladder.

Similar Registrations

Registration Number	Establishment Name	Location
3008772421	ADAPTA MEDICAL, INC.	Colorado Springs, CO, US
3011987967	ConvaTec, Inc.	Greensboro, NC, US
3009504230	Sterigenics Radiation Technologies IN, Inc	Columbia City, IN, US
3014404707	Hollister Services BV	Roosendaal Noord-Brabant, NL
3006405073	Sterigenics Denmark A/S	Espergaerde Sjalland, DK

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3031571464. Last updated year: 2026. Please use registration number 3031571464 when referencing this establishment in official correspondence.