Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008352437

FEI Number

3008352437

Entity Name

BEIER DRAWTEX HEALTHCARE (PTY) LTD

City/State/Country

Durban KwaZulu-Natal, ZA

Establishment Address

40 Gillitts Road, Pinetown, Durban KwaZulu-Natal 3600, ZA

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Beier Drawtex Healthcare (Pty) Ltd (Owner Number: 10032099)

Owner / Operator Contact Address

40 Gillitts Road, Pinetown, Durban, ZA-NL 3600, ZA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Drawtex Wound Dressing

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2010-04-08

Official Correspondent

Tracy Moonsamy

US Agent Details

Steven Dowdley Business: Urgo North America Email: steven.dowdley@us.urgo.com Phone: (678) 4518062

Related Public Records

Same Entity

Beier Drawtex Healthcare (Pty) 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 3008352437. Last updated year: 2026. Please use registration number 3008352437 when referencing this establishment in official correspondence.