Fresenius Kabi

What is established and what is not

No researcher review has been written for this company yet. 3 official records from 3 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. Nothing here confirms manufacturing, 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
• 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 2026-08-16. OpenSanctions
• 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 2026-08-16. OpenSanctions
• EU VAT number valid for cross-border trade (record type: vat-valid) [official record; status green] The number is registered and active: we asked the EU VIES service and it answered yes. An invalid VAT number is the first sign an invoice comes from the wrong company. checked 2026-08-18. VIES (European Commission)
• product-authorised-for-sale-holder (record type: product-authorised-for-sale-holder) [official record; status green] Applicant to the US FDA for 10 medical devices: KabiHelp® Uno; KabiHelp® Advance plus (K251139, 2026-01-09), freeflex+ Transfer Adapter (K212445, 2022-06-01), Vigilant Software Suite – Vigilant Master Med (K210075, 2022-03-01) +7. 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)
• Takes part in public tenders (record type: public-contract-awarded) [official record; status green] 1 public contracts on record, the latest awarded 2024-11-13. A public buyer selected this supplier through an official tender. Open the source for the contracts themselves. effective since 2024-11-13. TED (Tenders Electronic Daily), EU public procurement award notices 여기서 낙찰은 남이 한 심사까지 함께 뜻합니다. EU와 EEA에서는 공공 발주자가 사기, 부패, 자금세탁으로 유죄가 확정된 입찰자와 최종 결정으로 세금 또는 사회보험료 체납이 확인된 입찰자를 반드시 배제해야 합니다. 이 심사는 해당 입찰의 낙찰일 기준입니다. 회사의 현재 상황을 보여 주지 않으며, 낙찰이 계약 이행을 보여 주지도 않습니다. Directive 2014/24/EU, Article 57 (exclusion grounds)

Profiles

• linkedin
• facebook
• instagram

Claimed certifications, not confirmed by us

• Good Manufacturing Practice
• ISO 13485, Medical Devices Quality IAF CertSearch

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)

Check independently

Before a first order, ask for the Good Manufacturing Practice certificate number, its holder and the products it covers.

• Sanctions and watchlists (OpenSanctions)
• VAT number check (EU VIES)