Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015332213

FEI Number

3015332213

Entity Name

OSTOFORM LTD

City/State/Country

Mullingar Westmeath, IE

Establishment Address

Ostoform Limited, Unit 5C Fairgreen House, St. Lomans Terrace, Mullingar Westmeath N91 H635, IE

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Repack or Relabel Medical Device,Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Ostoform Ltd (Owner Number: 10060178)

Owner / Operator Contact Address

Ostoform Limited, Unit 5C Fairgreen House, St. Lomans Terrace, Mullingar, IE-WH N91 H635, IE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Ostoform FLOWASSIST Closed Pouch Ostoform FLOWASSIST Urostomy Pouch Ostoform FLOWASSIST Drainable Pouch Ostoform FLOWASSIST Convex Urostomy Pouch Ostoform FLOWASSIST Convex Drainable Pouch Ostoform Belt Ostoform FLOWASSIST Flat Baseplate FLOWASSIST Seal Ostoform FLOWASSIST Convex Baseplate Ostoform Crest Moldable Barrier Ostoform Barrier Extender

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EXB	Collector, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2022-12-15
EXE	Protector, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2019-04-08

Official Correspondent

No official correspondent registered.

US Agent Details

Kevin Kelleher Business: Ostoform Inc Email: info@ostoform.com Phone: (206) 9016338

Related Public Records

Same Entity

Ostoform Ltd

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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015332213. Last updated year: 2026. Please use registration number 3015332213 when referencing this establishment in official correspondence.