Certifications

Certified. Tested. Documented.

Our hydrogen machines are built to internationally recognised standards. Below is the certification framework that applies to the range; per-model documentation is available on request.

CE markingFCC complianceRoHS complianceISO 9001 quality managementISO 13485 manufacturing quality standard
What each standard covers

Plain-English breakdown

CE

CE marking

Indicates conformity with applicable European Economic Area health, safety and environmental protection requirements for the product category.

FCC

FCC compliance

Confirms the device meets United States Federal Communications Commission limits for electromagnetic interference from electronic equipment.

RoHS

RoHS compliance

Restricts the use of specific hazardous substances — including lead, mercury and cadmium — in electrical and electronic components.

ISO9001

ISO 9001 — Quality management

An international standard for quality management systems, covering documented processes, traceability and continuous improvement across manufacturing.

ISO13485

ISO 13485 — Manufacturing quality standard

A quality management standard our supply chain operates under for the manufacture of regulated equipment. Per-model applicability is being finalised with the supplier.

Model coverage

Per-model certification status

We are finalising the certificate-to-model mapping directly with the supplier. Until that mapping is confirmed and uploaded, every row carries a "documentation available on request" status. Email admin@hydrogenmachines.com.au for documentation on any individual model.

ProductCategoryCertification status
P58 Hydrogen InhalerInhalerCertificate coverage being finalised — documentation available on request
QY-A1200 Hydrogen InhalerInhalerCertificate coverage being finalised — documentation available on request
W30 Inhale + Drink All-in-OneInhalerCertificate coverage being finalised — documentation available on request
DLPA-HO1800 High-Flow InhalerInhalerCertificate coverage being finalised — documentation available on request
S69 Hydrogen Bath SystemBath systemCertificate coverage being finalised — documentation available on request
Single Nasal CannulaAccessoryCertificate coverage being finalised — documentation available on request
Dual Nasal CannulaAccessoryCertificate coverage being finalised — documentation available on request
Intelligent Steam Hydrogen Beauty MaskAccessoryCertificate coverage being finalised — documentation available on request
Hydrogen Eye Mask GogglesAccessoryCertificate coverage being finalised — documentation available on request
Nano-Bubble Hydrogenation RodAccessoryCertificate coverage being finalised — documentation available on request
300ml Hydrogen Water BottleAccessoryCE · FCC · RoHS

Full certification documentation is available on request: admin@hydrogenmachines.com.au.

Regulatory positioning

General wellness — not medical devices

Hydrogen Machines products are general wellness devices. They are not medical devices and are not intended to diagnose, cure, treat or prevent any disease. The certifications above relate to product safety, electromagnetic compliance, restricted substances and manufacturing quality — not to clinical claims. Consult a qualified health professional before starting any new wellness routine.