Key takeaways
- CE: meets EU electrical safety and EMC directives.
- FCC: meets US electromagnetic emissions limits.
- RoHS: restricted hazardous substances in components.
- ISO 9001: quality management system for the factory.
- ISO 13485: medical-device quality management system for the factory — not a medical-device approval.
Hardware certifications
CE and FCC apply to the finished device. They test for electrical safety and electromagnetic compatibility. RoHS is a materials declaration: solder, plastics and printed circuit boards comply with EU restricted-substance limits.
Factory certifications
ISO 9001 and ISO 13485 are management-system standards. They certify how the factory runs — documentation, traceability, complaint handling — not the device itself.
What none of these mean
None of these certifications make a hydrogen machine a medical device. They describe hardware and manufacturing quality, not therapeutic status.
Frequently asked questions
No. The CE mark on a hydrogen wellness machine covers electrical safety and EMC, not medical-device approval.
Related products
Flagship high-flow inhaler for multi-user sessions
HERO Inhaler Pro 3000
View product →
Inhale and produce hydrogen-rich water · three flow tiers
HERO Dual 20
View product →
3.75 L/min hydrogen-rich water at above 2,000 ppb — for baths, spas and aquariums, and for hydrogen-rich drip-irrigation across glasshouses, botanic gardens, vineyards, nurseries, hydroponic farms, lawns and golf courses up to 2 hectares.
HERO Bath Hydrogen Nano-bubble System
View product →
Related learning
Next lesson
Comparing specifications
Continue →Purity, tablets & bathing
- Hydrogen Bathing vs Hydrogen Tablets — Saturation versus dilution, compared in full.
- Hydrogen Water Purity — 99.991% certified purity from SPE/PEM electrolysis.
- Hydrogen Tablets: What You Should Know — What dissolving reactive material can leave behind.
Ready to choose a machine?
Direct prices · free worldwide delivery · 24-month warranty.
Source content adapted from certifications.