Every Ultra Controlo system is certified, audited, and validated by independent bodies. Not once. continuously.
The gold standard for medical device manufacturers. Covers our full design, production, installation, and servicing pipeline. from component sourcing to post-market surveillance. Third-party audited annually.
Notified Body 1639 certification under EU MDR 2017/745. Legal requirement for all medical devices sold in the EU. Recognised globally by procurement authorities in 80+ countries.
Organisation-wide quality framework. Required by most government and NGO procurement frameworks (WHO, UNOPS, UNICEF). Covers all operations beyond the production floor.
Certified since 2018. Systematic management of environmental impact across energy, waste, chemical handling, and logistics. from our Portugal facility outward.
Registered with INFARMED I.P.. mandatory for supplying Portuguese National Health Service (SNS) institutions. Confirms full EU regulatory compliance for device classification and post-market obligations.
Every system is designed and built at our Portugal facility. Full traceability from component to commissioning. 45 years of uninterrupted manufacturing under quality certification.
There are still hospitals in the world where a patient dies because a cylinder ran out. We started Ultra Controlo in 1981 to change that. 45 years later, that is still the only reason we come to work.
Certification is not a commercial box to tick. It is the minimum standard we hold ourselves to, because the people relying on our equipment have no margin for error.
Learn about Ultra Controlo80+ countries. Hospitals in DRC, Yemen, Bolivia, Pakistan. Every installation is proof that geography should not determine access to oxygen.
PSA technology that produces 95% pure medical oxygen on-site, from air. No cylinders. No supply chain dependency. Continuous, autonomous, certified.
Designed and manufactured at our headquarters since 1981. The same facility, the same standards, the same team — whether the destination is Lisbon or Liberia.
ISO certificates, CE declarations of conformity, technical dossiers. our team provides full compliance packages for hospital procurement and government projects.
