Certifications & compliance

Every CigGo device is produced under an ISO 13485:2016-certified quality management system — one of the few in the vaporizer industry certified to medical-device standards. Our ISO 13485:2016 certificate (issued 2026 by CROWN Certification Testing) is published below and independently verifiable; the remaining numbers and test reports are shared with buyers on request.

ISO 13485:2016 / GB/T 42061-2022 — Medical Device Quality Management System

Scope
Manufacturing (including design) and sales of medical nebulizers/electronic nebulizers, eye trackers, and medical electric chairs (export only)
Issued by
CROWN Certification Testing Co., Ltd. — IAS-accredited
Certificate number
40326MD00010R053
Valid
2026-04-20 – 2029-04-19

CE marking — European conformity

Scope
Electronic vaporizer devices for the European market
Certificate number
Supplied to buyers on request
Documentation
Certificate and test report supplied on request — ask sales

RoHS — Restriction of Hazardous Substances (Directive 2011/65/EU)

Scope
Restricted substances compliance for electronic assemblies
Certificate number
Supplied to buyers on request
Documentation
Certificate and test report supplied on request — ask sales

FCC Part 15 — Federal Communications Commission conformity

Scope
Electromagnetic interference compliance for the US market
Certificate number
Supplied to buyers on request
Documentation
Certificate and test report supplied on request — ask sales

Certificates are re-verified annually. Buyers needing document copies for customs or platform onboarding — ask sales, we typically respond within one business day.