Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8021955

FEI Number

3002806976

Entity Name

FEMCARE LTD.

City/State/Country

ROMSEY Hampshire, GB

Establishment Address

32 PREMIER WAY, ROMSEY Hampshire SO51 9DQ, GB

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

FEMCARE LTD. (Owner Number: 8021955)

Owner / Operator Contact Address

32 Premier Way, ROMSEY, GB-HAM SO51 9DQ, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

P920046

All Registered Proprietary Names

Supra Foley Catheter Introducer Filshie Tubal Ligation System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KOB	Catheter, Suprapubic (And Accessories)	Gastroenterology, Urology	Class 2	876.5090	2008-07-23
KNH	Laparoscopic Contraceptive Tubal Occlusion Device	Obstetrics/Gynecology	Class 3	884.5380	2008-07-23

Official Correspondent

Howard Beaumont

US Agent Details

Ben Shirley Business: Utah Medical Products Inc. Email: bshirley@utahmed.com Phone: (801) 5661200

Related Public Records

Same Entity

FEMCARE 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
K132890	Mediplus , Ltd.	SUPRAPUBIC CATHETER AND INTRODUCER SET	2014-01-17

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0037-2015	Richard Wolf Medical Instruments Corp.	3	The Hulka Clip is a sterile packaged medical device that carries a two year expiration date. It is packaged two clips per procedural tray. Theses procedural trays are then sealed in a Tyvek/Mylar pouch and packaged in a cardboard shipping carton with ten pouches in each shipping carton.

Similar Registrations

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3030446844	PLATINUM FOCUS GROUP LTD.	London London, City of, GB
1825146	Cook Incorporated	Spencer, IN, US
3030733800	AD SUPPLY GROUP LIMITED	London London, City of, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8021955. Last updated year: 2026. Please use registration number 8021955 when referencing this establishment in official correspondence.