Explore our high-precision single-use clinical supplies manufactured under ISO 13485 cleanroom protocols and exported directly to major medical centers in Seoul and Gyeonggi-do.
As a leading international manufacturer of single-use medical consumables (operated under Shree Umiya Surgical Pvt. Ltd. / Mediplus India since 1988), we supply fully certified, medical-grade Guedel Airways (Oropharyngeal Airways) and vascular access devices tailored specifically to the stringent regulatory and operational requirements of South Korea's healthcare sector.
The medical procurement landscape in Seoul—encompassing top-tier institutions such as Seoul National University Hospital (SNUH), Asan Medical Center, Severance Hospital, and the Seoul Metropolitan Fire & Disaster Headquarters (119 EMS)—demands compromise-free airway devices. Our custom OEM Guedel Airway manufacturing platform delivers superior pharyngeal clearance, anatomical compliance, and zero risk of cross-contamination or soft tissue trauma.
Every Guedel Airway leaving our facility is molded using 100% non-toxic, DEHP-free, phthalate-free medical-grade Polyvinyl Chloride (PVC) or Polyethylene (PE) compounds with semi-rigid Shore A durometer ratings (typically 80-85 Shore A). This precise rigidity prevents lumen collapse under involuntary jaw clenching or masseter spasms during anesthesia emergence or seizure episodes while maintaining enough flexure to prevent mucosal tear.
To support swift identification during critical emergency procedures across Seoul EMS units and surgical suites, our airways follow international ISO 5364:2016 color-coding standards. A rigid, color-coded insert is ultrasonic-welded into the proximal bite block area. This design prevents catheter occlusion if patients bite down during suctioning and provides clear size indicators (Size 000 for neonates through Size 6 for large adults).
| ISO Size | Nominal Length (mm) | Color Code (ISO 5364) | Target Clinical Patient Class (Seoul Health System) | Internal Lumen Diameter |
|---|---|---|---|---|
| Size 000 (40mm) | 40 mm | Pink / Clear | Premature Neonates / NICU Units | 3.5 mm |
| Size 00 (50mm) | 50 mm | Blue | Infants / Pediatric Emergency | 4.5 mm |
| Size 0 (60mm) | 60 mm | Black | Young Children / General Pediatrics | 5.5 mm |
| Size 1 (70mm) | 70 mm | White | Adolescents / Small Adults | 6.5 mm |
| Size 2 (80mm) | 80 mm | Green | Medium Adults / General Operating Rooms | 7.5 mm |
| Size 3 (90mm) | 90 mm | Yellow | Large Adults / Intensive Care Units | 8.5 mm |
| Size 4 (100mm) | 100 mm | Red | Extra-Large Adults / Bariatric Anesthesia | 9.5 mm |
| Size 5 & 6 (110-120mm) | 110 - 120 mm | Orange / Purple | Maxillofacial & Specialized Adult Trauma | 10.5 mm |
The distal tip of our OEM Guedel airway features micro-polished, rounded edges to minimize mechanical trauma to the posterior pharyngeal wall during insertion. The reinforced proximal flange is anatomically curved to sit flush against the patient's lips, facilitating easy tape or strap fixation while preventing accidental airway migration down the digestive or respiratory tract.
Optimized for Seoul's High-Density Tertiary Healthcare Ecosystem & Rapid Response Emergency Networks
Deployed in emergency rescue kits of the Seoul Metropolitan Fire and Disaster Headquarters. The robust bite-block resilience allows rapid upper airway patency maintenance during pre-hospital transport in congested urban traffic across Gangnam, Mapo, and Jongno districts.
Key Need: Crash-Cart Ready Sterile Blister PacksUtilized across major surgical centers (SNUH, Asan Medical Center, Samsung Medical Center) for non-invasive airway stabilization during anesthesia induction, emergence, and patient recovery in post-operative care units.
Key Need: DEHP-Free & KFDA Biocompatible MaterialsEssential for specialized plastic surgery clinics in Gangnam and private gastroenterology centers across Seoul performing deep conscious sedation. Prevents glossoptosis (tongue falling back) without irritating vocal cords.
Key Need: Soft Atraumatic Edges & Bulk OEM BrandingInsights into Regulatory Shifts, Environmental Directives, and OEM Supply Chain Demands in South Korea
South Korea’s Ministry of Food and Drug Safety (MFDS) requires strict Technical Dossiers, ISO 13485 QMS validation, and ISO 10993 cytotoxicity testing. Suppliers must deliver total batch-wise traceability from raw polymer to EO release.
Seoul's health authorities have instituted strict plasticizer restrictions. Importers are migrating towards non-phthalate medical PVC formulations for both airway devices and dialysis tubing sets.
With Incheon Port and Incheon Airport serving as primary entry gateways into South Korea, Korean medical distributors prefer suppliers capable of consolidated mixed-container shipments and custom pallet sizes.
Compliance with South Korea's Unique Device Identification (UDI) regulations requires precise barcoding, dual Hangeul/English artwork, and localized IFU inserts directly applied at factory origin.
36+ Years of Vertically Integrated Manufacturing Excellence from Ahmedabad to Global Medical Hubs
Operating under our parent organization, Shree Umiya Surgical Pvt. Ltd. (SUSPL / Mediplus) in Vatva, Ahmedabad, India, we offer an uncompromised synthesis of high-volume manufacturing cost efficiency and rigorous international quality standards. With over 400+ SKUs across 7 clinical specialties, our infrastructure provides distinct competitive advantages for OEM partners in Seoul:
In-house medical compound blending, precision injection molding, and automatic extrusion. Zero dependence on third-party sub-assembly eliminates inter-batch quality variance.
Assembly and primary packaging take place under positive pressure cleanroom environments with continuous air particulate monitoring and strict gowning protocols.
In-house automated EO sterilization chambers operating under ISO 11135 validation standards. Every lot undergoes biological indicator release and EO residue testing.
We work directly with South Korean medical brand owners, tender contractors, and hospital supply chains to provide comprehensive private-label programs:
Clear Technical & Operational Guidance for South Korean Medical Importers & Procurement Officers
Connect with our export sales division today to request product samples, factory-direct OEM quotation sheets, or technical regulatory files for your South Korean tender submissions.
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