Documented Compliance
CE marking maintained since 2008, now under EU MDR 2017/745, plus ISO 13485:2016, BIS and SFDA approvals.
Sterile drapes, AAMI Level 2–4 gowns and customised procedure packs manufactured in ISO 13485 certified cleanrooms and shipped to 25+ countries.
Component lists, drape sizes, fold sequence and labelling configured to your theatre workflow — reducing setup time and pack-opening waste.
Single-use CHG applicators, swab sticks, scrub brushes and disinfectant caps engineered for consistent dose delivery at every OR touchpoint.
CE marking maintained since 2008, now under EU MDR 2017/745, plus ISO 13485:2016, BIS and SFDA approvals.
Barrier, bursting-strength and linting checks run internally against AAMI PB70 and EN 13795 criteria.
Star Export House status with OEM, private-label and multi-language labelling support for distributors.
Surgeine Healthcare has focused on one discipline since 2002: what happens inside the sterile field. Four manufacturing units — including a dedicated facility for customised procedure packs commissioned in 2023 — produce single-use drapes, gowns, packs, skin-prep and OR turnaround products in 100K and 10K class cleanrooms.
Every category below is supplied sterile or non-sterile, in standard or facility-specific configurations, with barrier levels selected to match the fluid exposure of each procedure.
Speciality-specific sterile packs — ortho, C-section, cardiac, cataract and more — assembled to your component list.
Explore category EN 13795Fluid-control drapes with reinforcement zones, adhesive apertures and collection pouches for high-irrigation cases.
Explore category AAMI L2–L4Breathable SMS and reinforced Level 4 gowns with set-in or raglan sleeves and secure wrap-around closure.
Explore category Skin PrepSingle-use antiseptic applicators, swab sticks and pre-operative wipes for standardised patient skin preparation.
Explore category Post-Op CareReady-to-use dressing kits and specialised dressing packs that standardise ward and OPD wound-care rounds.
Explore category OR EfficiencyAll-in-one cleaning and changeover kits that cut between-case turnaround time and cross-contamination risk.
Explore category Asset ProtectionSterile covers for C-arms, microscopes, probes, camera heads and control panels within the sterile field.
Explore category Staff SafetyCoveralls, scrub suits, caps, shoe covers and visitor apparel for theatre, ICU and isolation areas.
Explore category Full PathwayScrub brushes, disinfectant caps, fixation devices, dental kits, bowls & trays and dried blood spot kits.
Explore categorySurgical site infections remain one of the most preventable complications in modern surgery. Our work is narrow by design: give every clinician a predictable, validated sterile field — the same way, every single case.
Select a panel to see how that belief translates into products, standards and practice.
Barrier performance is not a marketing claim — it is a measurable property that must survive fluid load, movement and time.
From a single focus on operating-room infection control in 2002 to a multi-unit export manufacturer.
A complete perioperative consumables platform rather than isolated SKUs — so procurement teams consolidate suppliers without losing specification control.
Continuous R&D, internal testing and documentation discipline keep our portfolio aligned with evolving regulation.
Experience shows up in the details — the products we industrialised first, and the approvals we sustained the longest.
Over-specifying barrier level raises cost and heat stress; under-specifying raises strike-through risk. This is the framework our technical team uses with hospitals and distributors when mapping a portfolio to a case mix.
| Barrier Level | Performance Focus | Typical Fluid Exposure | Indicative Use |
|---|---|---|---|
| AAMI Level 1 | Minimal water resistance (impact penetration) | Very low | Visitor apparel, basic cover gowns, non-invasive care |
| AAMI Level 2 | Low resistance to water impact and hydrostatic pressure | Low | Minor procedures, suturing, short-duration cases |
| AAMI Level 3 | Moderate resistance to water impact and pressure | Moderate | General surgery, orthopaedic and ENT procedures |
| AAMI Level 4 | Resistance to viral and microbial penetration under pressure | High / prolonged | Cardiac, trauma, arthroplasty, high-irrigation and long cases |
Barrier classification applies to critical zones defined in AAMI PB70; EN 13795 additionally evaluates microbial penetration (wet and dry), cleanliness, linting and bursting strength. Product-specific test reports are issued per batch family on request. Guidance above is indicative and does not replace your facility's clinical risk assessment.
Scale plus specialisation: four manufacturing units, an experienced leadership team in infection prevention, and a 300-strong field and plant organisation supporting hospitals in India and abroad.
In-house R&D develops new formats — from CHG delivery systems to fixation devices — and industrialises them for volume supply.
100K and 10K class cleanrooms, validated medical packaging and hotmelt lamination capability under one quality system.
Internal laboratories test barrier, strength and cleanliness parameters, with retained samples and batch traceability.
Packs, kits and labelling adapted to facility protocols, tender specifications and country-specific registration needs.
Material optimisation and waste reduction programmes, including pack right-sizing to reduce unused components.
Technical documentation, clinical education material and responsive commercial teams across export markets.
Regulatory documentation is part of the product. Our quality system is certified to ISO 13485:2016, and relevant device families carry CE marking under EU MDR 2017/745 — a certification obtained in 2024, building on CE compliance maintained continuously since 2008. Additional approvals include SFDA, BIS and ZED Gold, and Surgeine holds Star Export House recognition.
For importers and tender submissions we supply declarations of conformity, technical file summaries, sterilisation and biocompatibility evidence, batch test reports and labelling artwork for local language requirements. Certification scope is product-specific and should always be verified against the applicable documentation.
View All Certifications
CE Certificate
ISO 13485
ZED Gold
Export House
BISFive focused brands let clinical and procurement teams identify the right platform quickly — from customised packs to skin antisepsis and OR turnaround.
Customised Procedure Packs
Surgical Drapes and Packs
CHG Applicators and Swab Sticks
Surgical Dressing Kits
OR Turnaround Solutions“Surgeine's procedure packs measurably reduced our OR setup time. Sterility assurance and pack consistency have been reliable case after case, and our theatre workflow is noticeably smoother.”Dr. Rajiv MalhotraChief Surgeon, Apollo Hospitals, India
“The customisation options let us tailor every pack to a specific procedure list. Documentation is complete and their technical responsiveness during tendering made them our preferred supply partner.”Ms. Sarah ThompsonProcurement Head, NHS Trust, United Kingdom
“We have standardised on Surgeine packs across our hospital network for over three years. Compliance with AAMI and ISO 13485 requirements gives our infection-control committee confidence.”Dr. Ahmed Al-RashidMedical Director, Gulf Medical Centre
We operate an ISO 13485:2016 quality management system and have maintained CE marking since 2008, including certification under EU MDR 2017/745 obtained in 2024. Additional approvals include SFDA, BIS and ZED Gold. Certification scope is product-specific; applicable declarations of conformity, technical files and test reports are shared with importers and distributors on request.
Yes. A dedicated unit commissioned in 2023 focuses solely on customised procedure packs. Component lists, drape dimensions, gown barrier levels, fold sequence, pack orientation, tray layout, labelling and language can be configured to match facility protocols and tender specifications. Sample packs are produced for clinical validation before series supply.
Our regulatory team supplies the dossier elements commonly requested by health authorities — device descriptions, classification rationale, sterilisation and biocompatibility evidence, shelf-life data, labelling artwork and free-sale documentation — and works with your local regulatory consultant through the review cycle.
Yes. We run OEM and private-label programmes for distributors and group purchasing organisations across more than 25 countries, covering artwork adaptation, country-specific labelling, multi-language instructions for use, carton configuration and export documentation support.
For prolonged or high-irrigation cases — arthroplasty, trauma, cardiac and obstetric procedures — we recommend AAMI Level 4 reinforced gowns paired with drapes featuring reinforcement zones and fluid-collection pouches, plus CHG skin preparation and equipment covers for imaging devices entering the sterile field.
From India to more than 25 markets, our export team supports hospitals, distributors and group purchasing organisations with product selection, barrier-level mapping, documentation and long-term supply planning.
Tell us your case mix and specification, and we will propose the drape, gown, pack and skin-prep combination that fits your protocols and registration requirements.
