Materialise NV

What is established and what is not

No researcher review has been written for this company yet. 7 official records from 6 official sources are on file. 3 other entries are not official records: our own technical checks and searches, open directory listings, our inferences or the company's own statements. Everything is listed below with its evidence type: each entry confirms only what it literally says; none of them is a review. The manufacturing role above rests on the official records listed below, and only as far as each literally goes: a facility registration or licence is not an observation of current production. Nothing here confirms ownership or trading status beyond what each record literally says.

Facts on file, each with its evidence type

• Website domain registered (record type: domain-registered) [our own observation, not an official record; status green] Shows how long this web address has been registered. That is the age of the domain, not of the company: a domain can change owners. checked 2026-08-02. Domain registry record
• Active legal entity ID (LEI) (record type: lei-active) [official record; status green] A global identifier used in finance; an active one is renewed yearly. checked 2026-09-07. GLEIF global LEI register (golden copy)
• Takes part in public tenders (record type: public-contract-awarded) [official record; status green] 1 public contracts on record, the latest awarded 2026-03-04. A public buyer selected this supplier through an official tender. Open the source for the contracts themselves. effective since 2026-03-04. TED (Tenders Electronic Daily), EU public procurement award notices Ở đây việc trúng thầu còn mang theo một lần kiểm tra của bên khác: tại EU và EEA, bên mua công phải loại nhà thầu bị kết án gian lận, tham nhũng hoặc rửa tiền, và những nhà thầu bị quyết định cuối cùng xác định là nợ thuế hoặc nợ đóng góp xã hội. Lần kiểm tra đó chỉ áp dụng cho gói thầu ấy vào ngày trao thầu: nó không cho thấy tình trạng hiện nay của công ty, và trúng thầu không cho thấy hợp đồng đã được thực hiện. Directive 2014/24/EU, Article 57 (exclusion grounds)
• Market access approved: European Union (record type: market-access-eu) [official record; status green] Shows the establishment is approved for the listed activities under the EU food-hygiene rules and appears in the EU list of approved establishments. It is not an import check and not an observation of current production. checked 2026-08-22. TRACES NT, European Commission register of approved establishments (DG SANTE)
• product-authorised-for-sale-holder (record type: product-authorised-for-sale-holder) [official record; status green] Applicant to the US FDA for 60 medical devices: Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner (K260802, 2026-06-09), Mimics Thoracic Planner (K251964, 2026-03-12), Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models (K253308, 2026-01-07) +57. The applicant answers for the notification; the record does not say who makes the device. A national regulator lists this company as the holder of the registration of products it has authorised for sale in that country. The holder answers for the product on that market; the record does not say the holder makes it. effective since 2026-10-05. FDA premarket notifications 510(k) and De Novo (openFDA, U.S. Food and Drug Administration)
• No match found in the debarment registers we checked (record type: debarment-clear) [our own observation, not an official record; name search, no matching candidate] We searched the public debarment datasets and found no matching candidate. Absence from these lists is a search result, not a certificate. checked 2026-08-09. OpenSanctions
• No match found on the sanctions lists we checked (record type: sanctions-clear) [our own observation, not an official record; name search, no matching candidate] We searched the public sanctions datasets and found no matching candidate. A name search is not full compliance screening. checked 2026-08-09. OpenSanctions
• Legally registered and still active (record type: registry-active-global) [official record; status green] Shows the register lists the registration as active on the date we read it. It does not show how busy the business is. checked 2026-10-15. Crossroads Bank for Enterprises (KBO/BCE), full open-data file
• registry-activity (record type: registry-activity) [official record; status green] Shows what the state itself says the company does, which you can compare with what it promises you. checked 2026-10-15. Crossroads Bank for Enterprises (KBO/BCE), full open-data file
• Registry ID checks out with the state register (record type: registry-id-verified) [official record; status green] Helps confirm the company on this page is the same legal entity as in the register. checked 2026-09-10. GLEIF Global LEI record

Relationships

3 relationship(s) on file. Each line names the other party, the relationship as its source records it, and the source. A record of a relationship is not a finding about control beyond what it literally says.

Recorded in a source

• Technologielaan, 15, 3001, Leuven: Holds the site's permit, registry number BE 705/0179. TRACES NT, European Commission register of approved establishments (DG SANTE)

Candidates, not confirmed

• Belgium: Site named by the company itself, not confirmed by a record, country BE. materialise.com
• materialise.com: Website of this business. Source record

Import rules for these goods

• Medical devices sold in the EU must carry CE marking under the Medical Device Regulation (EU) 2017/745, with a conformity assessment matched to the device risk class. European Commission (MDR)
• For the US market, the maker must have an FDA device establishment registration and product listing; most instruments also need 510(k) premarket clearance. US FDA (devices)

Goods family established: Vật tư y tế và chăm sóc sức khỏe (registered activity code). The exact product, operation and trade route needed to determine a product-specific requirement are not established here. Product-specific import rules not established for the catalog category Máy móc công nghiệp: no record or company text names goods of this kind. A catalog category alone is our classification, not proof of what the company makes or sells.

Check independently

• Sanctions and watchlists (OpenSanctions)