FERTIPRO N.V.
Company-provided description, not an official-source fact. Certifications, capacities, years and market positions stated in it are the company's own claims until a record below confirms them.
フェルティプロのウェブサイト
1992 年に設立された FertiPro は、生殖補助医療や男性不妊症の診断に使用される体外診断薬および細胞培養培地の信頼できる独立メーカーです。最先端の製造 製造は、ベルギーのベールネムにある完全に環境管理された FertiPro 独自の最先端の製造施設で行われます。製品カタログ 弊社の製品カタログはこちらからダウンロードできます。 FertiPro の全製品範囲の概要を示します。認証と品質保証 FertiPro は ISO13485 認証を受けた企業であり、MDSAP プログラムに参加しています。 FertiPro は、ヨーロッパ、カナダ、アメリカ合衆国をはじめ、ますます多くの国で製品登録を行っています。すべての診断キットと ART 培地は CE マークを取得しています。
- Type
- manufacturer (our classification of the record, not a statement by the company)
- Role
- Manufacturer (official record)
- Location
- BEERNEM West-Vlaanderen, Belgium
- Website
- https://fertipro.com
- Categories
- 医療およびヘルスケア用品
Listed in a source registry
What is established and what is not
No researcher review has been written for this company yet. 5 official records from 5 official sources are on file. 4 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
- Site address listed in a government regulator's register (record type: facility-registered; this record does not by itself establish manufacturing) [official record; status green] Shows the regulator records a site of this company at a named address. A registration is not an observation of current production. effective since 2026-08-17. US FDA device establishment registration (openFDA)
- 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. Screened by name only: no legal entity is established for this record, so this is not a clearance. checked 2026-08-14. OpenSanctions
- Business email on the company's own domain (record type: corporate-mail-on-domain) [our own observation, not an official record; status green] Shows the domain runs its own email rather than a free mailbox. It describes the domain, not who owns it. checked 2026-08-14. Mail server of the company domain
- 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. Screened by name only: no legal entity is established for this record, so this is not a clearance. checked 2026-08-14. OpenSanctions
- Registered with the U.S. FDA (active, renewed for the current year) (record type: fda-registered) [official record; status green] Registered with the US food and drug regulator, renewed for the current year. checked 2026-08-14. FDA
- 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 2026-08-14. Domain registry record
- 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)
- manufacturing-practice-certified (record type: manufacturing-practice-certified) [official record; status green] A regulator of health products inspected this site and certified how it manufactures the product class named, for example medical devices or cosmetics. It is about manufacturing practice at the site, not a medicines licence. checked 2026-10-03. ANVISA (Brazilian Health Regulatory Agency), public register of Good Manufacturing Practice certificates (CBPF)
- Registered as a manufacturer (record type: registered-manufacturer) [official record; status green] Its own declared activity in the register covers making these goods. checked 2026-10-03. ALIMS (Medicines and Medical Devices Agency of Serbia), register of medical-device manufacturers
Relationships
1 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.
Candidates, not confirmed
- Industriepark Noord 32, 8730, Beernem: Holds the site's permit, registry number FAGG2017042001. TRACES NT, European Commission register of approved establishments (DG SANTE)
Import rules for these goods
Product-specific import rules not established for the catalog category 医療およびヘルスケア用品: neither the company's own description nor an official activity code shows that its own goods are of this kind. A catalog category alone is our classification, not proof of what the company makes or sells.