HART BIOLOGICALS LTD

Listed in a source registry

US FDA device registration and listing (open.fda.gov)

What is established and what is not

No researcher review has been written for this company yet. 12 official records from 8 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 2026-08-12. Domain registry record
• Market access approved: European Union (record type: market-access-eu) [official record; status green] Shows the facility is on the destination market's list of establishments approved for the listed goods. A listing is not an observation of current production. checked 2026-08-22. TRACES NT, European Commission register of approved establishments (DG SANTE)
• 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. checked 2026-08-12. 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 2026-08-12. FDA
• Registered with the U.S. FDA as a Contract Manufacturer (record type: fda-contract-manufacturer) [official record; status green] Registered as making goods for other brands. checked 2026-08-12. FDA
• 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 2026-08-12. OpenSanctions
• Active in the UK registry (record type: ch-active) [official record; status green] The national company register still lists it as active. checked 2026-08-12. Companies House
• registry-activity (record type: registry-activity) [official record; status green] Line of business as recorded in the state register: 32500 - Manufacture of medical and dental instruments and supplies. Shows what the state itself says the company does, which you can compare with what it promises you. effective since 2002-08-28. Companies House free company data product (UK)
• On the company register (record type: registered-since) [official record; status green] On the company register since 2002-08-28. Shows how long the company has been on the state register, which is hard to fake and easy to check. effective since 2002-08-28. Companies House free company data product (UK)
• Named directors on file (record type: directors-on-file) [official record; status green] 2 directors on file. The register names the people who run the company, so there is someone answerable if something goes wrong. checked 2026-08-12. Companies House
• A director was appointed, on the official record (record type: officer-appointed) [official record; status green] Shows that a named person answers for the company on the public record. checked 2026-08-12. Companies House (officers)
• Directors named in the company register (record type: leadership-on-record) [official record; status green] Registry lists Director: Alexander Marc Ebinger. The people leading the company are named in a public record. checked 2026-08-12. Companies House (officers)
• Owners named in the company register (record type: ownership-on-record) [official record; status green] Controlling owner on record: Hart Holdings Ltd. Names the company's owners or controllers as the register records them. checked 2026-08-12. Companies House (PSC)
• Annual accounts filed with the register (record type: annual-accounts-filed) [official record; status green] Annual accounts filed for 2024. Indicates the company still meets its reporting duties. checked 2026-08-12. Companies House (accounts)

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

• Sanctions and watchlists (OpenSanctions)