Puncak Bumi Utama Sdn Bhd

What is established and what is not

No researcher review has been written for this company yet. 1 official record from 1 official source is 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

• 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 2026-08-12. 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 2026-08-12. OpenSanctions
• 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
• 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

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)
• Upcoming, not yet applicable on 2026-10-14: If the goods are made of wood, placing them on the EU market falls under the Deforestation Regulation (EUDR): the operator files a due-diligence statement with geolocation of the wood's origin; furniture not made of wood is outside it. The EU Deforestation Regulation applies to large and medium operators from 30 December 2026 and to micro and small operators from 30 June 2027; due-diligence intensity depends on the risk level the Commission assigns to the country of production. European Commission (EUDR)
• Consumer goods sold in the EU fall under the General Product Safety Regulation (GPSR, applies since 13 Dec 2024): a responsible person in the EU is mandatory. EUR-Lex: Regulation (EU) 2023/988 (GPSR)

Goods family established: Nội thất (the company's own text), Vật tư y tế và chăm sóc sức khỏe (the company's own text). The exact product, operation and trade route needed to determine a product-specific requirement are not established here. Product-specific import rules not established for the catalog category Kim loại, thép và khai khoáng: no record or company text names goods 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 production site address and a document linking that site to this legal entity.

• Sanctions and watchlists (OpenSanctions)