Hartalega
丁腈手套制造商，在马来西亚拥有大型工厂。
贺特佳为医疗保健和工业防护市场生产丁腈和乳胶检查手套。该公司经营自动化手套工厂，为全球医疗分销商和 OEM 客户提供服务。
- Type
- Manufacturer
- Location
- Kuala Lumpur, Malaysia
- Founded
- 1988
- Website
- hartalega.com.my
- Categories
- 医疗保健用品, 安全及防护设备
- Markets
- 马来西亚, 美国, 德国, 新加坡
Verified facts
- web-presence-since (green), checked 2026-08-07 Internet Archive (Wayback)
- certificate-page-on-site (amber), checked 2026-08-11 Company's own certification page
- sanctions-clear (green), checked 2026-08-06 OpenSanctions
- fda-registered (green), checked 2026-08-06 FDA
- debarment-clear (green), checked 2026-08-06 OpenSanctions
- corporate-mail-on-domain (green), checked 2026-08-06 Mail server of the company domain
- fda-contract-manufacturer (green), checked 2026-08-06 FDA
Claimed certifications
- ISO 9001, Quality Management IAF CertSearch
- ISO 13485, Medical Devices Quality IAF CertSearch
- FDA Registered FDA Establishment Registration
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)
- Protective equipment (helmets, gloves, eyewear) sold in the EU falls under the PPE Regulation (EU) 2016/425 and needs CE marking. European Commission (PPE)