Lekhim
Company-provided description, not an official-source fact. Certifications, capacities, years and market positions stated in it are the company's own claims until a record below confirms them.
肿瘤学、免疫学和仿制药
Lekhim 在其哈尔科夫工厂生产肿瘤药物、免疫制剂和无菌注射剂。该公司还生产一次性注射器和输液器等医疗器械。它拥有一个为国际制药客户提供服务的合同制造部门。
- Type
- Not established by any record (our catalog import lists it as manufacturer; that is not evidence of the role)
- Role
- Role not established by any record
- Location
- Kharkiv, Ukraine
- Founded
- 1992 (from our catalogue record; not confirmed by the company or by a state register)
- Website
- https://lekhim.ua
- Categories
- 医疗保健用品
- Markets
- 乌克兰, 波兰, 哈萨克斯坦, 阿塞拜疆, 乌兹别克斯坦, 摩尔多瓦, 白俄罗斯, 格鲁吉亚
What is established and what is not
No researcher review has been written for this company yet. No official record 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
- 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 2026-08-09. 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 2026-08-09. 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 2026-08-09. OpenSanctions
Claimed certifications, not confirmed by us
- ISO 9001, Quality Management 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 legal entity's registration number and country, then check it in the official register.