Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011657181

FEI Number

3011657181

Entity Name

SAFEGUARD MEDICAL TECHNOLOGIES LTD

City/State/Country

Hereford Herefordshire, GB

Establishment Address

Unit G Moreton Business Park, Moreton-On-Lugg, Hereford Herefordshire HR4 8DS, GB

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Safeguard US Operating LLC (Owner Number: 10048998)

Owner / Operator Contact Address

13359 Reese Blvd. E, Huntersville, NC 28078, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ChitoGauze XR Pro Steady-Head Nasal Airway Russell PneumoFix Russell PneumoFix-8 Safeguard OmniSplint Pelvic Splint Prometheus Traction Splint

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QSY	Hemostatic Wound Dressing Without Thrombin Or Other Biologics	Unknown	Class U	N/A	2016-07-01
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2015-03-30
BTQ	Airway, Nasopharyngeal	Anesthesiology	Class 1	868.5100	2025-09-22
GCB	Needle, Catheter	General, Plastic Surgery	Class 1	878.4200	2015-03-30
FPP	Stretcher, Hand-Carried	General Hospital	Class 1	880.6900	2024-03-26
NOC	Splint, Extremity, Non-Inflatable, External, Non-Sterile	General, Plastic Surgery	Class 1	878.3910	2020-11-25
HSQ	Belt, Pelvic, Traction	Orthopedic	Class 1	888.5890	2020-11-25
HSP	Splint, Traction	Orthopedic	Class 1	888.5890	2015-03-30

Official Correspondent

No official correspondent registered.

US Agent Details

Kimberly Reed Email: kimberlyr@safeguardmedical.com Phone: (855) 4286074

Related Public Records

Same Entity

Safeguard US Operating LLC

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9616791	Waismed Ltd.	Rosh Haayin Central, IL

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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0006-2025	Ossur H F Grjothals 5 Reykjavik Iceland	1	Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101

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3005378067	VEXXUS MEDICAL INC.	SANTO DOMINGO Distrito Nacional, DO
1018233	C.R. BARD, INC.	COVINGTON, GA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011657181. Last updated year: 2026. Please use registration number 3011657181 when referencing this establishment in official correspondence.