Regulations

Working with gas: safety, rules and
regulations is part of who we are
Twin Tower for medical use

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. 

+ 0
medical references
+ 0
marine references
+ 0
food and beverages references

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

Our PSA generators has been MDD 93/42/EC (medical device directive) approved since 2017. 

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

By obtaining the the Free Sales Certificate OXYMAT obtain the right to market and export medical PSAs without
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:

Bureau Veritas logo
ABS logo
Rina logo
Lloyds logo
Korean Register logo
ClassNK logo
China Classification Society CCS logo

Quality

To learn more about our approach to quality and to see generic certificates, please visit our quality page.

OXYMAT can deliver premium quality oxygen and nitrogen generators