Certificates & Compliance
Last updated: 31 August 2026
Release notice: checkout stays closed until the UAE conformity file is complete. The documents we hold are published in full on the documents page; what is still missing is listed there by name.
We publish our compliance documents openly. The manufacturer of the mask is Shenzhen Rainbow Technology Co., Ltd (Bao'an District, Shenzhen). Every certificate is issued to the manufacturer, not to us.
What we hold today
Eight documents, each published as the original PDF on the documents page:
- FDA 510(k) K253712 — United States clearance, Class II, cleared 23 January 2026
- ARTG 524063 — Australian Register of Therapeutic Goods, Class IIa, certificate DV-2026-MC-01226-1, 2 March 2026 (sponsor: Share Info Pty Ltd)
- Health Canada Medical Device Licence 115038 — Class 2 family licence, first issued 10 March 2026
- CE — Low Voltage Directive, certificate RED2507030672433ED-AM, RED Laboratories, 3 July 2025
- CE — EMC, certificate RL2507030672436ED-AM-R, RED Laboratories, 3 July 2025
- CE — RoHS, certificate XNO250724007AX2-1, Guangzhou Supreme Technology, 29 July 2025
- UKCA — EMC, certificate RED2511060672762ED-AM, RED Laboratories, 6 November 2025
- FCC Part 15C test report DLE-250818002R, FCC ID 2BME6-RB051, 18 August 2025 (433.92 MHz remote control)
Not in our file yet
Requested from the manufacturer, and published here as they arrive. We do not hold any of these today:
- Laser safety classification — we hold none, and none of the eight documents above refers to EN or IEC 60825
- IEC 62471 photobiological safety report DE25070016 (STC Guangdong, 17 November 2025, model RB-061 named) — confirmed by the manufacturer; we hold the cover page, the full report is confidential
- Signed EU and UK Declarations of Conformity
- European radio equipment file (EN 300 220, EN 301 489) for the 433.92 MHz remote
- UN 38.3 lithium battery test report and battery safety data sheet
- ISO 13485 quality-management certificate of the manufacturing facility
- The underlying test reports behind the CE and UKCA certificates
- A written specification sheet on manufacturer letterhead — wavelengths, emitter count, irradiance, runtime
UAE registration
- MoIAT conformity assessment — in preparation
- TDRA radio type approval for the 433.92 MHz remote — in preparation
- UAE import, customs and seller-of-record mapping — to be confirmed for the exact product before paid orders open
Scope
FDA clearance applies in the United States, the ARTG entry in Australia and the Health Canada licence in Canada. None of them is an approval, clearance or registration in the United Arab Emirates, the GCC, the European Union or the United Kingdom. The CE and UKCA documents are test-house certificates, not approvals granted by any authority. An earlier set of documents on this page was issued to a different manufacturer for a different unit; those documents have been withdrawn.
Questions about compliance? Email [email protected].
