Integer Holdings Corporation
Kontrak manufaktur perangkat medis untuk OEM terkemuka di dunia.
Integer Holdings Corporation adalah salah satu produsen kontrak perangkat medis terbesar di dunia, yang memproduksi instrumen bedah listrik, komponen manajemen ritme jantung, kabel neurostimulasi, dan baterai canggih untuk perangkat medis. Perusahaan ini juga memproduksi solusi daya non-medis untuk aplikasi komersial khusus. Integer mengoperasikan lebih dari 20 lokasi manufaktur di AS, Irlandia, Jerman, India, dan Tiongkok, melayani pelanggan OEM jantung, neuromodulasi, dan bedah terkemuka.
- Type
- Manufacturer
- Location
- Plano, TX, United States
- Founded
- 1970
- Website
- integer.net
- Categories
- Perlengkapan Medis & Kesehatan, Perlengkapan Industri
- Markets
- Amerika Serikat, Irlandia, Jerman, Tiongkok, India, Australia
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)