Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005103920

FEI Number

3005103920

Entity Name

CULZEAN TEXTILE SOLUTIONS LTD

City/State/Country

Irvine North Ayrshire, GB

Establishment Address

1 Chalmers Place, Riverside Business Park, Irvine North Ayrshire KA11 5DH, GB

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Culzean Textile Solutions Ltd (Owner Number: 10039740)

Owner / Operator Contact Address

1 Chalmers Place, Riverside Business Park, Irvine, GB-NAY KA11 5DH, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Delta Dry Stockinette

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ITG	Bandage, Cast	Physical Medicine	Class 1	890.3025	2021-09-23
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2012-02-07

Official Correspondent

matthew ogden

US Agent Details

Rebecca Russo Business: BSN Medical Inc Email: Rebecca.russo@essity.com Phone: (704) 5517174

Related Public Records

Same Entity

Culzean Textile Solutions Ltd

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005103920. Last updated year: 2026. Please use registration number 3005103920 when referencing this establishment in official correspondence.