E-E-A-T Verified Standards
Full compliance with AAMI PB70 (Levels 1–4) and EN 13795 standards, backed by third-party testing for hydrostatic head pressure, impact penetration, and linting.
For over 20 years, Surgeine Healthcare has specialized in operating room safety and surgical barrier solutions. Operating four specialized cleanroom manufacturing units in India, we deliver ISO 13485:2016 and CE EU MDR 2017/745 certified disposables designed to lower surgical site infection (SSI) risks in demanding clinical environments.
A documented timeline of quality achievements, regulatory accreditations, and product industrialization.
Surgeine Healthcare was established in India with a single-minded objective: elevating operating room hygiene and protecting healthcare personnel through precision-engineered single-use surgical drapes and protective apparel.
Initiated export operations to healthcare distributors across the Middle East, establishing long-term supply partnerships built on batch consistency and strict specification control.
Became one of the early Indian medical disposable manufacturers to secure CE Marking, laying the groundwork for continuous international regulatory compliance across European and global markets.
Industrialized India's first domestic production lines for CHG (Chlorhexidine Gluconate) single-use applicators, swab sticks, scrub brushes, and needle-free disinfectant caps for pre-operative skin preparation.
Upgraded quality systems to ISO 13485:2016 standard for medical device design and manufacturing, integrating in-house packaging and environmental monitoring controls.
Awarded Star Export House status by the Government of India in recognition of sustained export volume growth, high product reliability, and international compliance record.
Expanded Class 100K cleanroom capacity to rapidly scale supply of AAMI Level 2-4 isolation gowns, protective coveralls, and specialized barriers during global shortages.
Commissioned a dedicated, state-of-the-art facility focused entirely on custom surgical procedure packs (CPTP), enabling procedure-specific drape, gown, and component customization.
Successfully transitioned device portfolio certifications to the stringent European Medical Device Regulation (EU MDR 2017/745), providing importers with complete technical dossiers and regulatory backing.
Now serving 300+ hospital groups, group purchasing organizations (GPOs), and distribution partners in 25+ countries across 5 continents, showcasing Indian manufacturing excellence on international stages like MEDICA Düsseldorf.
We combine controlled cleanroom environment standards with verified barrier testing to satisfy government tenders and hospital networks worldwide.
Full compliance with AAMI PB70 (Levels 1–4) and EN 13795 standards, backed by third-party testing for hydrostatic head pressure, impact penetration, and linting.
Every raw material lot undergoes rigorous tensile strength, burst strength, and microbial barrier analysis in our controlled testing lab before assembly.
End-to-end support for international medical brands, including multi-language pouch printing, custom folding sequences, and country-specific regulatory dossiers.
Whether you are looking to standardise surgical procedure packs, source EU MDR certified AAMI Level 4 surgical gowns, or establish private-label distribution in your market, our technical sales specialists are ready to assist.