Insulet
Bomba de insulina sin cámara y dispositivos para el control de la diabetes.
Insulet fabrica bombas de insulina sin cámara y dispositivos para el control de la diabetes en sus operaciones de Acton. La empresa suministra sistemas de atención médica, laboratorios, socios OEM o clientes de exportación regulados en sus mercados primarios listados.
- Type
- brand seeking distribution
- Location
- Acton, United States
- Founded
- 2000
- Website
- insulet.com
- Categories
- Suministros médicos y sanitarios, Wearables y dispositivos personales
- Markets
- Estados Unidos, Alemania, Reino Unido, Canadá
Verified facts
- corporate-mail-on-domain (green), checked 2026-08-08 Mail server of the company domain
- domain-registered (green), checked 2026-08-08 Domain registry record
- sanctions-clear (green), checked 2026-08-08 OpenSanctions
- debarment-clear (green), checked 2026-08-08 OpenSanctions
- lei-lapsed (amber), checked 2026-08-23 GLEIF global LEI register (golden copy)
Claimed certifications
- 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)
- Electronics for the EU need CE marking incl. RoHS substance limits, and producers must register for WEEE take-back in each member state of sale. European Commission (CE)
- Electronics for the US market need FCC equipment authorization under 47 CFR Part 15, which covers unintentional radiators such as switch-mode power supplies, not only radio devices. US FCC (Part 15)