Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3026963399

FEI Number

3026963399

Entity Name

Materialise S.A.

City/State/Country

Bielany Wroclawskie Dolnoslaskie, PL

Establishment Address

Belgijska 1, Bielany Wroclawskie Dolnoslaskie 55-040, PL

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

MATERIALISE N.V. (Owner Number: 9029485)

Owner / Operator Contact Address

Technologielaan 15, --, Leuven, BE-NOTA 3001, 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
HQZ	Frame, Spectacle	Ophthalmic	Class 1	886.5842	2024-01-30

Official Correspondent

No official correspondent registered.

US Agent Details

Jenny Jones Business: MATERIALISE USA, LLC. Email: jenny.jones@materialise.com Phone: (734) 2597017

Related Public Records

Same Entity

MATERIALISE N.V.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3006543248	Materialise Motion N.V.	Paal Limburg, BE
3003998208	MATERIALISE N.V.	LEUVEN Vlaams Brabant, BE
3009555440	Materialise Ukraine, Rep. office	Kyiv Kyyiv, Misto, UA
3011724582	Materialise Colombia S.A.S	Medellin Antioquia, CO
3005718816	Materialise USA, LLC.	Plymouth, MI, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K910951	United Optical, Spa	OPTHLAMIC FRAMES	1991-05-06

Similar Registrations

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3005147601	VISIONTECH EXPORT INTERNATIONAL (PVT) LTD.	KARACHI Sindh, PK
3009554831	ROGER EYE DESIGN	Etten-Leur Noord-Brabant, NL
3013507321	DEM FACTORY S.R.L.	Limana Belluno, IT
3015243992	L.G.R SRL	Roma, IT

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3026963399. Last updated year: 2026. Please use registration number 3026963399 when referencing this establishment in official correspondence.