Insulet
Pompa insulin tubeless dan perangkat manajemen diabetes.
Insulet memproduksi pompa insulin tubeless dan perangkat manajemen diabetes dari operasi Acton-nya. Perusahaan ini memasok sistem perawatan kesehatan, laboratorium, mitra OEM, atau pelanggan ekspor teregulasi di seluruh pasar utama terdaftarnya.
- Type
- manufacturer (our classification of the record, not a statement by the company)
- Role
- Manufacturer
- Location
- Acton, United States
- Founded
- 2000
- Website
- insulet.com
- Categories
- Perlengkapan Medis & Kesehatan, Perangkat yang Dapat Dipakai & Perangkat Pribadi
- Markets
- Amerika Serikat, Jerman, Inggris Raya, Kanada
What is established and what is not
No facet of this company has been investigated yet. The facts below are collected records, not an assessment: nothing here confirms manufacturing, ownership or trading status beyond what each record literally says.
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 2026-09-07 GLEIF global LEI register (golden copy)
- registry-id-verified (green), checked 2026-09-10 GLEIF Global LEI record
Claimed certifications, not confirmed by us
- 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)