Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9617198

FEI Number

3006402425

Entity Name

SALTS HEALTHCARE LIMITED

City/State/Country

ASTON BIRMINGHAM, GB

Establishment Address

RICHARD ST, ASTON BIRMINGHAM B7 4AA, GB

Establishment Type(s)

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

Owner / Operator

SALTS HEALTHCARE LIMITED (Owner Number: 9019444)

Owner / Operator Contact Address

RICHARD ST, ASTON, GB-ENG B7 4AA, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Harmony Duo Confidence Be Confidence Natural Soft Convex Confidence Natural Advance Confidence Convex Supersoft Second Nature Confidence Natural Salts Flange Extender with Aloe Salts Mouldable Seals with Aloe Salts Barrier Film Protective Wafer Dermacol Salts Mouldable Seals Salts Adhesive Remover Odour Eliminating Spray Saltair Adhesive Solution Salts No-Roma Peri Prep Salts Flange Extender Salts Stoma Paste Confidence Natural Soft Convex Confidence Natural Advance Confidence Comfort Confidence Convex Supersoft Confidence Natural Harmony Duo STOMA GUIDE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EZQ	Pouch, Colostomy	Gastroenterology, Urology	Class 1	876.5900	2000-03-27
FON	Bag, Drainage, With Adhesive, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2000-03-27
EZS	Appliance, Colostomy, Disposable	Gastroenterology, Urology	Class 1	876.5900	2001-06-11
EXB	Collector, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2000-03-27
EXA	Selector, Size, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2006-11-27

Official Correspondent

No official correspondent registered.

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

SALTS HEALTHCARE LIMITED

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2012	Convatec Inc.	1	Natura Durahesive ConvaTec Moldable Technology Post-Operative /Surgical System (57 mm) Required for application to a patient immediately after ostomy surgery.

Similar Registrations

Registration Number	Establishment Name	Location
3006709396	AMPARO MEDICAL TECHNOLOGIES, INC.	Anaheim, CA, US
3019865496	Dongguan Kangda Medical Technology Co., Ltd	Dongguan Guangdong, CN
3008806809	ConvaTec Limited, GDC Building	Deeside Flintshire, GB
3020978007	DONGGUAN BAO KANG DIAN ZI KE JI LIMITED	Dongguan City Guangdong, CN
3005327291	SHANGHAI NEO-MEDICAL IMPORT & EXPORT CO., LTD.	SHANGHAI, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9617198. Last updated year: 2026. Please use registration number 9617198 when referencing this establishment in official correspondence.