Integer Holdings Corporation
为世界领先的 OEM 制造医疗器械合同。
Integer Holdings Corporation 是全球最大的医疗器械合同制造商之一，生产电外科器械、心律管理组件、神经刺激导线和医疗器械先进电池。该公司还为专业商业应用生产非医疗电源解决方案。 Integer 在美国、爱尔兰、德国、印度和中国运营着 20 多个制造基地，为领先的心脏、神经调节和外科 OEM 客户提供服务。
- Type
- Manufacturer
- Location
- Plano, TX, United States
- Founded
- 1970
- Website
- integer.net
- Categories
- 医疗保健用品, 工业用品
- Markets
- 美国, 爱尔兰, 德国, 中国, 印度, 澳大利亚
Verified facts
- debarment-clear (green), checked 2026-08-12 OpenSanctions
- sanctions-clear (green), checked 2026-08-12 OpenSanctions
- domain-registered (green), checked 2026-08-14 Domain registry record
- lei-lapsed (amber), checked 2026-08-23 GLEIF global LEI register (golden copy)
Claimed certifications
- ISO 13485, Medical Devices Quality IAF CertSearch
- ISO 9001, Quality Management IAF CertSearch
- FDA Registered FDA Establishment Registration
- CE Marking EU NANDO (notified bodies)
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)