Surgeine Healthcare is a specialized manufacturer and global supplier of single-use surgical disposables and perioperative infection-prevention products. Founded in 2002, our company operates four specialized production facilities engineered to meet the stringent demands of international group purchasing organizations (GPOs), medical distributors, and healthcare systems.
Our vertical manufacturing infrastructure includes Class 100K (ISO 8) and Class 10K (ISO 7) cleanrooms, automated nonwoven converting lines, in-house hotmelt lamination, and validated medical pouch packaging. Every batch produced is traceable from raw material to finished sterile goods.
Protecting surgical teams and surgical patients worldwide through reliable, verified single-use barrier solutions.
To elevate operating room safety standards by developing, manufacturing, and delivering sterile surgical disposables built on zero-defect quality control. We empower surgeons, nurses, and infection preventionists by mitigating surgical site infection (SSI) risks in every procedure.
To expand our footprint as the preferred B2B OEM manufacturing partner for medical device brands and hospital supply networks across Europe, the Americas, the Middle East, and Asia-Pacific through continuous material R&D and supply chain excellence.
We bridge the gap between high-volume manufacturing cost efficiency and uncompromising international regulatory compliance.
Gowns and drapes tested against fluid hydrostatic pressure, viral penetration (ASTM F1671), and linting under EN 13795 protocols.
Batch-level physical and biological testing conducted on-site, providing importers with full Certificates of Analysis (COA) for every shipment.
Specialty-specific procedure kits assembled according to exact hospital tray layouts, fold preferences, and clinician component requests.
Complete technical files, bio-compatibility reports, sterilisation validation data, and Free Sale Certificates supplied for target country registration.
Private label capabilities including customized inner pouch printing, GS1 barcoding, master carton artwork, and multi-language IFUs.
Recognized Star Export House with established sea and air logistics channels serving health authorities and distributors in 25+ countries.
Quality and regulatory documentation are integral to every medical device we export. Surgeine operates under a certified ISO 13485:2016 Quality Management System. Our key product families hold CE Marking compliance certified under the stringent EU MDR 2017/745 regulation.
For tender submissions, GPO evaluations, and national health authority approvals, we supply comprehensive Technical Documentation, Declarations of Conformity, EO Sterilisation Validation (EN ISO 11135), and Biocompatibility Reports (ISO 10993 series).
EU MDR CE Mark
ISO 13485:2016
ZED Gold Standard
Star Export House
BIS CertifiedWhether you are seeking custom procedure packs, OEM surgical gown manufacturing, or high-barrier drapes for hospital tenders, our export team is ready to assist with specifications, samples, and competitive pricing.
