Regulations
Working with gas: safety, rules and regulations is part of who we are
We are the experts
OXYMAT work within several industries with strict rules and regulations – we have become an expert on safety, rules and regulations, when it comes to use of gas in different industries.
If your country specific regulation is not listed here, we are still sure, we are able to live up to them.
Contact us, to talk more about your specific restrictions and requirements.
MEDICAL
Quality assurance is pivotal when working in the medical field.
OXYMAT PSA generators hold all relevant approvals and are constantly working to comply to new standards.
MDR
PSA generators from our production in Slovakia has been approved for MDR 2017/745 (medical device regulation).
The following generators are approved according to MDR:
Oxygen PSA generators CE marked as medical device and produced by OXYMAT – Slovakia, s.r.o. after May 4, 2022 (see product nameplate):
O10; O20; O40; O60; O70; O100; O190; O280; O430; O640; O880; O1250; O1500, O880 X2; O1250 X2; O1500 X2
Our MDD production in Denmark will apply for MDR approval in 2023.
MDD
The following generators are approved according to MDD:
Oxygen PSA generators CE marked as MD (Medical Device) and produced by OXYMAT – Slovakia, s.r.o. before May 4, 2022 (see product nameplate):
O10; O20; O40; O60; O70; O100; O190; O280; O430; O640; O880; O1250; O1500, O880 X2; O1250 X2; O1500 X2
and
Oxygen PSA generators CE marked as Medical Oxygen Generator and produced by OXYMAT A/S (see product nameplate):
O20-1,O20-2, O20-3, O20-4, O20-5, O20-6; O200-1, O200-2, O200-3, O200-4, O200-5, O200-6 O200-3 X2, O200-4 X2, O200-4 X3, O200-4 X4, O200-4 X5, O200-4 X6 O20-1 (pallet),O40-1 (pallet), O60-1 (pallet), O20-2 (pallet), O40-2 (pallet), O60-2 (pallet), O20-3 (pallet), O40-3 (pallet), O60-3 (pallet) O20 (Half Pallet), O40 (Half pallet), O60 (Half pallet)
Free Sales Certificate
any approval from the Danish Medicines Agency.
Other certificates
Please visit our Quality page to see generic certificates, registrations and policies.
MARINE
We have been sub-supplier to the marine industry for decades. We know the characteristics and class societies of the industry and we can deliver according to the rules of:
Quality
To learn more about our approach to quality and to see generic certificates, please visit our quality page.
