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We place special emphasis on observing regulatory norms with a stringency paralleled by few in the industry. Thanks to our dedicated team of experts committed to ensuring we remain in line, our facilities are compliance with requirements of US FDA.
Adhering to the strictest standards in quality control, product design and development, prototyping, packaging and sterilization, all our products are certified by CE, compliance with the European Medical Device Directive 93/42/EEC (as amended 2007/47/EC) and packaged as per EN 980 standards.
US FDA 510k Cleared, CE Marked, MDSAP, ISO 13485:2016, EU-MDR 2017 certified
Indian FDA Approved | GMP Certificate
USA
Auxein Inc.
1500 Nw 89th Court, Suite 107-108,
Doral, Florida 33172
Tel: +1 305 395 6062
E Fax: +1 305 395 6262
Email: USoffice@auxein.com
Mexico
Auxein México S.A. de C.V.
Tepic 139 int 801, Colonia Roma Sur,
Alcaldía Cuauhtémoc, CDMX,
México, C.P. 06760
Tel: +521 55 7261 0318
Email: info@auxein.mx
Dubai UAE
Auxein Medical Trading FZCO
Oud Metha Offices Building,
B Block 1st Floor Office No.26,
Near Healthcare City,
PO BOX-25572
Tel: +971 438 71333
Email: info@auxein.com
India
Auxein Medical Pvt. Ltd.
Plot No. 168-169-170, Phase-4,
Kundli Industrial Area,
HSIIDC, Sector-57, Sonepat – 131028,
Haryana
Tel: +91 99106 43638 | Fax: +91 86077 70197
Email: info@auxein.com