Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1000614268

FEI Number

1000614268

Entity Name

STERIMEDIX LTD.

City/State/Country

REDDITCH Worcestershire, GB

Establishment Address

26 THORNHILL ROAD, NORTH MOONS MOAT, REDDITCH Worcestershire B98 9ND, GB

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

STERIMEDIX LTD. (Owner Number: 9061957)

Owner / Operator Contact Address

26 Thornhill Road, North Moons Moat, REDDITCH, GB-WOR B98 9ND, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

AJ1851T AJ1850T AJ1861T 03418 03419

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2011-06-13
MXY	Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal	Ophthalmic	Class 1	886.4350	2004-03-12
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2012-06-21
KYG	Device, Irrigation, Ocular Surgery	Ophthalmic	Class 1	886.4360	2004-03-12
HMX	Cannula, Ophthalmic	Ophthalmic	Class 1	886.4350	2004-03-12
HMQ	Marker, Sclera	Ophthalmic	Class 1	886.4570	2007-12-04
HNY	Cystotome	Ophthalmic	Class 1	886.4350	2004-03-12
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2009-07-20
NGY	Cannula, Trocar, Ophthalmic	Ophthalmic	Class 1	886.4350	2015-01-27

Official Correspondent

No official correspondent registered.

US Agent Details

Angelika Scherp Business: BUSINESS SUPPORT INTERNATIONAL Email: info@bsi-fda.com Phone: (212) 3318358

Related Public Records

Same Entity

STERIMEDIX LTD.

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
K863293	Lifestream Int'L, Inc.	DISPOSABLE SUCTION CANNULA NO. 902008-000	1986-09-09
K854401	Microsurgical Technology, Inc.	THE NEW MOBILE TIP MCINTYRE CANNULA	1985-12-30
K781371	Ferris Mfg. Corp.	BONE MARROW ASPIRATION KIT	1978-09-20

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0011-2019	Ellex iScience, Inc.	1	ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the label is Ellex iScience, Inc., Fremont, CA. Used in ophthalmic surgery.
Z-0022-2009	Becton Dickinson and Company	1	BD Visitec High Viscosity Injector, 4mm Ref: 585173. The product is intended for Vitroretinal Surgery.
Z-0017-2023	Hobbs Medical, Inc.	1	Hobbs Transbronchial Aspiration Needle and Vacu-lok Aspirating Syringe Catalog Number: 4620
Z-0018-2023	Hobbs Medical, Inc.	1	Hobbs Transbronchial Aspiration Needle Catalog Number: 4621
Z-0023-2011	Becton Dickinson & Company	1	BD 30G1/2 PrecisionGlide Needle;Catalog/Lot Number: 305106. Needles are intended for use in aspiration and injection of medications.

Similar Registrations

Registration Number	Establishment Name	Location
3023138850	AQ THERAPEUTICS, INC.	Irvine, CA, US
1526439	DEPUY SPINE, INC.	RAYNHAM, MA, US
1058584	Sterigenics US LLC	Charlotte, NC, US
1221763	ARCH Medical Solutions - Seabrook	SEABROOK, NH, US
8043496	REDA INSTRUMENTE GMBH	TUTTLINGEN Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1000614268. Last updated year: 2026. Please use registration number 1000614268 when referencing this establishment in official correspondence.