Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005818605

FEI Number

3005818605

Entity Name

Speciality Fibres and Materials Limited

City/State/Country

Coventry, GB

Establishment Address

Galaxy House - 31 Herald Way, Binley Industrial Estate, Coventry CV3 2RQ, GB

Establishment Type(s)

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

Owner / Operator

Speciality Fibres and Materials Limited (Owner Number: 10021853)

Owner / Operator Contact Address

Galaxy House, 31 Herald Way, Binley Industrial Estate, Coventry, GB-COV CV3 2RQ, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2019-08-19
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2024-12-04
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2007-10-03
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2007-10-03

Official Correspondent

No official correspondent registered.

US Agent Details

Kenneth M Nicoll Nicoll Business: Law Offices of Kenneth M Nicoll, LLC Email: nicolllawoffices@aol.com Phone: (203) 8784681

Related Public Records

Same Entity

Speciality Fibres and Materials 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
K150256	Argentum Medical	SILVERLON BURN CONTACT DRESSINGS	2015-04-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-06	B. Braun Medical, Inc.	U	D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025	3M Company Health Care Business 3m Center	U	3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005818605. Last updated year: 2026. Please use registration number 3005818605 when referencing this establishment in official correspondence.