Hartalega

What is established and what is not

No researcher review has been written for this company yet. 4 official records from 3 official sources are on file. 5 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

• First recorded on the web archive (record type: web-presence-since) [our own observation, not an official record; status green] The company website was already online in 2002. Shows a web archive saw a page at this address on that date. It does not show who ran the site then. checked 2026-08-07. Internet Archive (Wayback)
• Certificates named on their own site (record type: certificate-page-on-site; this record does not by itself establish manufacturing) [stated or published by the company, not an official record; status amber] Shows where the company itself claims the certificate, so you can open that page and judge it. checked 2026-09-18. Company's own certification page
• EAEU product declaration on record, company's role not established (record type: eaeu-product-declaration-party; this record does not by itself establish manufacturing) [official record; status green] An official EAEU register holds a declaration for specific goods that names this company; the record we hold does not say in which role (manufacturer, applicant or representative). It shows those products may be sold on the EAEU market, not a general quality mark. Paste the document number into the register search to see the record. checked 2026-08-16. EAEU unified register of certificates and declarations
• Places goods on the market (national producer register) (record type: places-goods-on-market; this record does not by itself establish manufacturing) [official record; status green] A state register lists this company as placing these goods on the market, as their maker or importer. By itself it does not show who makes them. checked 2026-08-19. MDA MMDR (Malaysia Medical Device Register, Medical Device Authority), public search
• 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 2026-08-06. 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 2026-08-06. FDA
• 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 2026-08-06. 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 2026-08-06. Mail server of the company domain
• 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 2026-08-06. FDA

Claimed certifications, not confirmed by us

• ISO 9001, Quality Management IAF CertSearch
• ISO 13485, Medical Devices Quality IAF CertSearch

Import rules for these goods

Product-specific import rules not established for the catalog categories Medical & Healthcare Supplies, Safety & Protective Equipment: 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.

Check independently

Before a first order, ask for the ISO 9001, Quality Management certificate number, its holder and the products it covers.

• Sanctions and watchlists (OpenSanctions)