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 Here the award carries someone else's check: in the EU and the EEA a public buyer must exclude bidders convicted of fraud, corruption or money laundering, and those found by a final decision to owe taxes or social contributions. That check applied to this tender on the date of the award: it does not show the company's situation today, and winning a contract does not show that it was carried out. Directive 2014/24/EU, Article 57 (exclusion grounds)

Profiles

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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)