Medical-grade sterile procedure packs engineered under ISO 13485 & CE certification for hospital, ICU, and clinical operating environments.
Ultra-fluid resistant SMMS fabric with critical-zone reinforcement for high-fluid catheterization and surgical access procedures.
Get a Quote
Complete perioperative tray including fluid-resistant barrier gown, silicone Foley catheter, drainage bag, and sterile drape.
Get a Quote
Class I medical device certified kit featuring fenestrated drapes, absorbent towels, and catheter access accessories.
Get a Quote
Customizable hospital prep pack with prep swabsticks, sterile drape, gauze pads, and insertion apparel for clinical care.
Get a Quote
Heavy-duty protection kit for ICU and operating theatre, ensuring zero strike-through during high-volume drainage procedures.
Get a Quote
Precision-packaged non-woven protective kit including doctor coat, sterile gloves, CHG applicators, and catheter dressing.
Get a Quote
Ultrasonically sealed SMS fabric apparel with specialized fenestrated sterile drape for spinal and catheterization procedures.
Get a Quote
35-45gsm high-barrier lint-free SMS non-woven material designed to minimize hospital-acquired infections (HAIs).
Get a QuoteIn-depth comparative research evaluating global contract manufacturers, OEM suppliers, and cleanroom fabricators specializing in clinical catheterization, vascular access, and urinary management trays.
Manufacturing Overview: Established in 2002, Surgeine Healthcare operates four state-of-the-art cleanroom manufacturing units (100K and 10K ISO-classified) dedicated to single-use surgical disposables, specialized procedure packs, and pre-packaged catheterization kits. Pioneering India’s first domestically produced CHG applicators, swab sticks, and customized procedure trays, Surgeine maintains total vertical integration—from hotmelt lamination and medical packaging to an internal testing laboratory established for barrier and bursting-strength verification.
Competitive Advantage & Information Gain: Surgeine excels in full OEM/private-label customization for group purchasing organizations (GPO) and international medical distributors across 25+ countries. Their 2023-commissioned custom procedure tray plant allows hospital-specific protocol tailoring, including custom drape sizes, AAMI Level 2-4 barrier gown selection, fold sequence optimization, and multi-language packaging, reducing theatre setup time by up to 40%.
BD remains a global leader in vascular access and urological care kits. Known for their proprietary Safety-Lok catheter insertion mechanisms and infection-prevention closed Foley trays, BD sets high industry standards for clinical efficacy. However, high unit costs and strict minimum order thresholds often lead hospital procurement managers to seek flexible B2B OEM partners for standardized bulk supply.
Teleflex specializes in critical care and vascular access catheterization sets under the renowned Arrow® brand. Incorporating chlorhexidine and silver sulfadiazine antimicrobial catheter impregnations, Teleflex focuses heavily on reducing Central Line-Associated Bloodstream Infections (CLABSI) in ICU environments.
As one of the largest private medical suppliers in North America, Medline provides expansive catalog options for Foley catheterization trays and custom surgical procedure packs. Medline’s ERA (Educate, Reinforce, Advocate) CAUTI prevention platform integrates standardized catheter kits with healthcare staff training modules.
Operating from Germany, B. Braun produces premium regional anesthesia, dialysis, and vascular access catheter kits. Built upon strict European standard DIN EN ISO 13485 and EU MDR compliance, B. Braun’s products are favored in high-budget clinical facilities across Western Europe and East Asia.
Cardinal Health operates extensive global manufacturing facilities supplying standardized urological and surgical catheter drapes. Their Presource® Kitting platform serves large hospital networks, focusing on high-volume logistics and inventory replenishment.
Coloplast is a global benchmark for intermittent self-catheterization kits and ostomy solutions. Featuring advanced hydrophilic coatings that eliminate manual lubricant application, Coloplast kits are designed for patient comfort and reduced mucosal trauma.
Following the acquisition of Smiths Medical, ICU Medical manufactures high-precision epidural insertion kits, lumbar puncture sets, and specialized arterial catheterization trays under the historical Portex® brand name.
Cook Medical focuses on interventional radiology and urological procedure sets, including perc-nephrostomy catheter kits, biliary drainage trays, and dilator sets, holding a strong clinical position in specialized surgical subdisciplines.
Winner Medical is a major East Asian contract manufacturer of non-woven surgical dressings and simple catheter prep components. Serving as an upstream bulk supplier, Winner provides raw non-woven materials and high-volume basic procedural assemblies.
A technical reference guide for hospital procurement heads, infection control committees, and medical device importers when evaluating barrier standards and kitting components.
| Procedure Kit Type | Core Catheter Components | Barrier Standard (AAMI PB70 / EN 13795) | Antisepsis & Fluid Control | Target Clinical Application |
|---|---|---|---|---|
| Sterile Foley Catheterization Kit | 100% Silicone 2-Way/3-Way Foley, 2000ml Drainage Bag with Anti-Reflux Valve, Lube Syringe | AAMI Level 2 / Level 3 Drapes & Towels | CHG 2% w/v & 70% IPA Swabsticks, Specimen Container | Urological catheterization, perioperative bladder retention management. |
| Central Venous Catheter (CVC) Insertion Tray | Multi-Lumen CVC Catheter, Guidewire, Nitinol Introducer Needle, Scalpel, Vessel Dilator | AAMI Level 4 High-Barrier Full Body Fenestrated Drape | CHG Skin Prep Applicator, Needleless Connectors, Suture Wing | ICU vascular access, long-term IV therapy, hemodynamic monitoring. |
| Epidural & Anesthesia Procedure Pack | Tuohy Needle, Epidural Catheter, LOR Syringe, Flat Filter 0.22 micron, Fixation Device | AAMI Level 3 SMS Non-Woven Fenestrated Drape | Povidone-Iodine / CHG Prep Tray, Gauze Sponges, Prep Cup | Surgical anesthesia, obstetric epidural analgesia, postoperative pain control. |
| Peritoneal Dialysis Catheter Kit | Tenckhoff Catheter, Tunneler, Adapter, Transfer Set, Titanium Connector | AAMI Level 3 Fluid Resistant Barrier Apparel & Field Drapes | Disinfectant Caps, Sterile Gauze Dressing, Fenestrated Drape | Nephrology, end-stage renal disease (ESRD) outpatient maintenance. |
| Percutaneous Nephrostomy / Drainage Set | Pigtail Drainage Catheter, Stiffening Cannula, Initial Access Needle, Fascial Dilators | AAMI Level 4 High-Fluid Collection Bag & Reinforced Drape | CHG Applicators, Hydrocolloid Fixation Dressings, Securement Straps | Interventional radiology, renal obstruction drainage, abscess aspiration. |
Key technological transformations driving hospital procurement decisions and OEM supplier evaluation in catheterization management.
Global health authorities (US CDC, European Centre for Disease Prevention and Control) are mandating standardized "all-in-one" insertion kits. Hospitals are shifting away from buying loose catheter components toward single sterile trays containing CHG skin prep, barrier drapes, bio-seal dressings, and closed-system drain lines to minimize infection risks.
Next-generation catheter manufacture utilizes photo-linked hydrophilic coatings and micro-encapsulated antimicrobial agents (such as chlorhexidine diacetate and silver nanoparticles). These coatings reduce insertion friction coefficients to near-zero, suppressing microbial biofilm adhesion for up to 30 days post-insertion.
With the transition deadline for EU MDR enforcement, non-certified medical kit assemblers face market exclusion. Healthcare purchasing networks now require complete Technical Files, clinical evaluation reports (CER), ethylene oxide (EO) residual testing reports, and ISO 11135 sterilization validation for every catheter tray SKU.
Combining 23+ years of medical cleanroom manufacturing with stringent compliance discipline to support worldwide hospital tenders and private-label programs.
Commissioned in 2023, Surgeine operates specialized Class 100,000 (ISO Class 8) and Class 10,000 (ISO Class 7) controlled cleanroom environments exclusively dedicated to procedure pack assembly, guaranteeing low initial bioburden levels.
Equipped with internal testing laboratories since 2020, Surgeine rigorously verifies barrier penetration, hydrostatic head pressure, bursting strength, and linting propensity in accordance with EN 13795 and AAMI PB70 standard specifications.
Recognized with Star Export House and ZED Gold status, Surgeine provides comprehensive regulatory dossiers (STED), declarations of conformity, batch release testing reports, and custom packaging in over 25 countries worldwide.
Official certifications backed by international notified bodies and regulatory agencies.
CE EU MDR 2017/745
ISO 13485:2016 QMS
ZED Gold Certificate
Star Export House
BIS Standard Certified
Addressing essential technical, regulatory, and logistics queries regarding catheter kit manufacturing and global sourcing.
Catheter kits and sterile procedure trays are regulated as medical devices requiring compliance with ISO 13485:2016 Quality Management Systems. In the European Union, catheter packs must hold CE Marking under EU MDR 2017/745 (Rule 7/Rule 11 for invasive catheters). In the United States, 510(k) clearances or FDA registration apply. Additionally, sterilization processes must strictly conform to ISO 11135 (Ethylene Oxide) or ISO 11137 (Gamma Irradiation) with documented bioburden and sterility assurance levels (SAL 10⁻⁶).
Yes. OEM factories like Surgeine Healthcare specialize in full kitting customization. Procurement managers can specify catheter French size (Fr 6 to Fr 24), material composition (100% silicone, latex, or hydrogel-coated), drainage bag capacities (2000ml, 4000ml with anti-reflux valves), drape aperture dimensions, AAMI PB70 gown protection levels (Level 2 to Level 4), and antiseptics (2% CHG / 70% IPA swabsticks or Povidone-Iodine cups).
Catheter-Associated Urinary Tract Infections (CAUTI) are significantly reduced when clinical staff utilize standardized, pre-packaged sterile trays. Bundled kits enforce strict aseptic technique by presenting components in sequential order of insertion step: hand hygiene prep -> sterile barrier drape & gloves -> CHG skin antisepsis -> pre-lubricated catheter insertion -> closed-system drain bag connection -> securement device placement. This eliminates item-by-item retrieval and reduces contamination opportunities.
Importers typically require a comprehensive regulatory dossier provided by the manufacturer. Key documents include: (1) ISO 13485 Certificate, (2) CE Certificate of Conformity or FDA 510(k) summary, (3) Free Sale Certificate (FSC), (4) Ethylene Oxide Residual Analysis Reports (ISO 10993-7), (5) Biocompatibility Test Reports (ISO 10993-1), (6) Shelf-life and Package Integrity Validation (ISO 11607), and (7) Multi-language IFU (Instructions for Use) and artwork adaptations.
Medical-grade sterile catheter packs packaged in medical-grade paper/film pouch combinations or thermoformed rigid trays feature a validated shelf life of 3 to 5 years from the date of sterilization. Storage conditions require cool, dry environments away from direct sunlight, maintaining barrier integrity provided the primary packaging remains undamaged and unopened.
Partner with an established ISO 13485 & CE MDR certified factory. Contact our technical team for custom catheter kit engineering, sample evaluation, and competitive contract pricing.
Get a Quote