Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003836856

FEI Number

3003836856

Entity Name

SHEFFMED LIMITED

City/State/Country

Rotherham, GB

Establishment Address

Unit 4, Coggin Mill Way; Centurion Business Park; Bessemer Way, Rotherham S60 1FB, GB

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

SHEFFMED LIMITED (Owner Number: 9058364)

Owner / Operator Contact Address

UNIT 4, cogginmill way, Rotherham, GB-NOTA S601fb, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Buchanan Kapi-Gel HENCKEL FORCEPS TILLEY AURAL FORCEPS Biopsy Forceps Ear Probe Jobson Wax hook Crocodile forcep Micro Scissors Stapes Hook ST Barts Blunt Hook MAGILL SUCTION TUBE 3 X 110mm (9FG) SUCTION TIPS 16G STERILE SUCTION TIPS 14G STERILE SUCTION CONTROLLER STERILE LONG SUCTION 3 X 350mm (9FG) SUCTION TIPS 20G STERILE FRAZIER SUCTION TUBE 3 X 100mm (9FG) ZOELLNER SUCTION TUBE 30 DEG WITH HOLE LONG SUCTION 3 X 250mm (9FG) FRAZIER SUCTION TUBE 3 X 140mm (9FG) ZOELLNER SUCTION TUBE 30 DEG FRAZIER SUCTION TUBE 2 X 100mm (6FG) LONG SUCTION 4 X 350mm (12FG) BELUCCI SUCTION TUBE 2 X 110mm (6FG) SUCTION TIPS 18G STERILE ZOLLENER FINE END 18 SWG ZOELLNER SUCTION TUBE 35 DEG FLAT HANDLE SUCTION TIPS 22G STERILE Ointment Applicator with Syringe FORMBY CERUMEN SCOOP & HOOK TUMARKIN SPECULA GRUBER SPECULA SHEA AURAL SPECULA Sheffmed

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BYD	Condenser, Heat And Moisture (Artificial Nose)	Anesthesiology	Class 1	868.5375	2022-04-21
KAC	Tube, Laryngectomy	Ear, Nose, Throat	Class 1	874.4420	2022-04-21
KAE	Forceps, Ent	Ear, Nose, Throat	Class 1	874.4420	2026-02-27
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2025-01-03
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2023-04-17
KCP	Syringe, Ent	Ear, Nose, Throat	Class 1	874.5220	2026-02-27
JYG	Curette, Ear	Ear, Nose, Throat	Class 1	874.4420	2026-02-27
EPY	Speculum, Ent	General, Plastic Surgery	Class 1	878.1800	2026-02-27
LGG	Instrument, Cast Application/Removal, Manual	Orthopedic	Class 1	888.5980	2014-05-07

Official Correspondent

sonia hobson

US Agent Details

Gina Lastner Email: lastner.usagent@gmail.com Phone: (443) 8577630

Related Public Records

Same Entity

SHEFFMED LIMITED

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
K143738	Intuit Medical Products, LLC	DSS Sinusplasty Balloon Catheter	2015-08-27
K834189	Imm Enterprises , Ltd.	JAKOBI SURG. INSTRUMENTS #7 44/47	1984-03-06

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2013	Invuity, Inc.	2	BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray. The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high intensity light source.

Similar Registrations

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3011587055	SHAOXING UNDIS MEDICAL TECHNOLOGY COMPANY LIMITED	Shaoxing Zhejiang, CN
3003898360	Teleflex Medical de Tecate, S. de R.L de C.V.	TECATE Baja California, MX
1314417	SunMed Group Holdings, LLC	Grand Rapids, MI, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003836856. Last updated year: 2026. Please use registration number 3003836856 when referencing this establishment in official correspondence.