Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005538501

FEI Number

3005538501

Entity Name

TWE Meulebeke NV

City/State/Country

Meulebeke West-Vlaanderen, BE

Establishment Address

marialoopsteenweg 51, Meulebeke West-Vlaanderen B-8760, BE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

TWE Meulebeke NV (Owner Number: 10043868)

Owner / Operator Contact Address

Marialoopsteenweg 51, Meulebeke, BE-VWV 8760, BE

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
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2024-03-21
ITG	Bandage, Cast	Physical Medicine	Class 1	890.3025	2013-03-30

Official Correspondent

Robin Van den Fonteyne

US Agent Details

Kristopher McNeill Email: kristopher.mcneill@twe-group.com Phone: (336) 4317187

Related Public Records

Same Entity

TWE Meulebeke NV

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 3005538501. Last updated year: 2026. Please use registration number 3005538501 when referencing this establishment in official correspondence.