Engineered to meet stringent international standards (ISO 13485, CE, WHO-GMP), serving medical device assemblers, hospitals, and industrial OEMs across Ho Chi Minh City, Hanoi, Bac Ninh, and Binh Duong.
Multi-lumen polyurethane & platinum-cured silicone extensions with radiopaque stripe for accurate X-ray placement in critical care.
Premium surgical stainless steel cannula engineered for veterinary laparoscopy, livestock procedures, and animal care.
High-grade surgical steel trocar set featuring custom laser logo branding, precise bevel sharpening, and ergonomic grips.
Safe and reliable surgical equipment with smooth cannula insertion, low friction silicone seals, and leak-proof stopcocks.
Medical grade thoracic catheter featuring silicone drainage tubing, radio-opaque markings, and sterile EO barrier protection.
Custom curved silicone and stainless steel tubing configured for ENT procedures, minimised tissue trauma, and clear endoscopic viewing.
Bladeless optical tip design reducing abdominal wall trauma, paired with high-durability silicone stability threads.
Safety laparoscopic trocar assembly with immediate blade retraction mechanism and flexible silicone seal ring for clinic use.
Under National Resolution No. 20-NQ/TW and updated MoH Decree 98/2021/ND-CP, Vietnam is experiencing unprecedented modernization across public healthcare, localized medical device assembly, and high-tech manufacturing hubs.
Vietnam’s manufacturing landscape has expanded rapidly beyond basic plastic molding into medical-grade polymer extrusion and automated assembly. Strategic industrial corridors—such as Saigon Hi-Tech Park (SHTC) in Ho Chi Minh City, Hoa Lac Hi-Tech Park in Hanoi, and key provinces including Bac Ninh, Binh Duong, and Dong Nai—are attracting global healthcare manufacturers. These operational environments demand direct factory access to custom OEM silicone tubing, platinum-cured peristaltic pump lines, and biocompatible catheter components with zero supply chain disruption.
The Vietnamese Ministry of Health (MoH) enforces strict regulatory frameworks for Class A, B, C, and D medical devices. Procurement teams require full documentation: ISO 13485 Quality System certificates, ISO 10993 Biocompatibility test reports, Ethylene Oxide (EO) sterilization validation (ISO 11135), and Certificate of Free Sale (CFS). Sterimed Group provides end-to-end technical dossiers, facilitating smooth customs clearance at major Vietnamese logistics hubs including Cat Lai Port (HCMC) and Hai Phong Port.
Detailed technical matrix assisting design engineers and procurement officers in Vietnam in selecting optimal durometers, thermal stability profiles, and fluid-transfer characteristics.
| Performance Parameter | Platinum-Cured Silicone (Ultrasil Pureline) | Peroxide-Cured Silicone Tubing | Standard Medical Grade PVC |
|---|---|---|---|
| Curing Mechanism | Addition Polymerization (No By-products) | Free-Radical Catalysis (Organic Peroxides) | Plasticized Thermoplastic Extrusion |
| Extractables & Leachables | Ultra-Low (Zero Peroxide Residue or Acid By-products) | Trace Organic Acids & Volatile By-products | Risk of Phthalates (DEHP/DOP) Migration |
| Hardness (Shore A) | 30 Shore A to 80 Shore A (Customizable ±3) | 40 Shore A to 80 Shore A | 50 Shore A to 95 Shore A |
| Tensile Strength (MPa) | 9.5 – 11.5 MPa | 7.5 – 9.0 MPa | 12.0 – 16.0 MPa |
| Elongation at Break (%) | 500% – 750% | 350% – 500% | 250% – 400% |
| Biocompatibility Standard | USP Class VI, ISO 10993 Full Compliance | USP Class V / Industrial Grade | ISO 10993 Limited Duration |
| Thermal Range (°C) | -60°C to +230°C (Autoclavable up to 134°C) | -40°C to +200°C | -10°C to +70°C (Heat Sensitive) |
| Peristaltic Pump Life | Superior Spallation Resistance (>1000 Hours) | Moderate (Prone to Micro-flaking) | Unsuitable for Dynamic Pumping |
From intensive care units in Hanoi's Bach Mai Hospital to bio-pharmaceutical fermentation plants in Binh Duong, our OEM extruded silicone products solve critical fluid handling challenges.
Medical OEMs in Vietnam rely on our micro-bore silicone extrusion for endotracheal tubes, cuffed tracheostomy lines, central venous catheters, and Foley drainage systems. Incorporating radiopaque barium sulfate stripes ensures precise fluoroscopic visualization during surgical interventions.
Vietnam’s expanding pharmaceutical sector requires ultra-pure fluid pathways. Our Ultrasil Platinum-Cured Silicone Tubing handles aseptic liquid transfer, cell culture media, and vaccine filling lines inside WHO-GMP certified facilities without altering fluid chemistry.
Extensively deployed in dairy processing plants in the Mekong Delta and Dong Nai, our food-grade silicone tubes withstand SIP (Steam-In-Place) and CIP (Clean-In-Place) chemical sterilization while maintaining taste neutrality and compliance with FDA 21 CFR 177.2600.
Surgeons across Vietnamese provincial hospitals utilize our 3R Disposable Bladeless Trocars and Stainless Steel Veterinary Cannulae. Integrated custom silicone seals maintain pneumoperitoneum during complex endoscopic operations.
Equipped with low compression set and precise wall tolerances (down to ±0.05mm), our custom silicone hoses power automated pathology analyzers, peristaltic dosing pumps, and reagent distribution manifolds in diagnostic labs nationwide.
For industrial machinery manufacturers in Bac Ninh and Hai Phong, we produce reinforced silicone braided hoses (Ultrasil Polybraid) and custom molded silicone profiles capable of resisting ozone, UV exposure, and continuous thermal stress up to 230°C.
Over six decades of specialized polymer engineering, cleanroom manufacturing excellence, and dedicated international trade support.
Operating dedicated production lines equipped with automatic laser micrometer feedback loops, Sterimed ensures precise outer diameter (OD) and inner diameter (ID) tolerances. Polymer extrusion, cutting, tip-forming, and double-pouching take place in validated ISO Class 8 (Class 100,000) cleanrooms to minimize particulate contamination.
Our engineering division develops custom extrusion dies within 10 to 14 days. Whether your application requires multi-lumen tubing, dual-durometer bonded shafts, silicone-coated latex, or custom color coding (pantone matching), our R&D cell provides rapid physical prototyping and sample validation.
We simplify medical device registration for Vietnamese importers. Every order includes complete batch certificates of analysis (CoA), raw material traceability logs, USP Class VI biocompatibility reports, EO sterilization residual testing records, and CE Declaration of Conformity.
Leveraging trade protocols under regional agreements, we offer structured trade terms (FOB, CIF, DDP to HCMC/Hanoi) with complete documentation support including Certificate of Origin (Form E/AIFTA), enabling Vietnamese distributors to maximize margin structure and duty reduction.
Essential answers regarding minimum order quantities, custom tooling, Ministry of Health filings, and shipping schedules.
All Sterimed silicone extrusion and catheter manufacturing facilities operate strictly under ISO 13485:2016 and ISO 9001:2015 Quality Management Systems, alongside WHO-GMP accreditation. Products hold valid CE marks and full biocompatibility dossiers (ISO 10993 / USP Class VI), ensuring instant compliance with Vietnamese Ministry of Health (MoH) device registration dossiers under Decree 98/2021/ND-CP.
Yes. We specialize in custom OEM extrusion with durometers ranging from 30 Shore A to 80 Shore A. We can produce micro-bore tubing (ID down to 0.5mm), multi-lumen configurations (2-way to 6-way), radiopaque lines, cut-to-length sleeves, and pre-formed bent silicone tubes engineered specifically for your device assembly lines.
Standard manufacturing lead times for stock extrusion dies range from 2 to 3 weeks. Custom OEM tooling requires 10 to 14 days for mold fabrication and sample approval. Sea freight transit from major Indian ports (such as Nhava Sheva or Chennai) to Cat Lai Port (HCMC) or Hai Phong Port takes approximately 10 to 14 days, providing a fast supply chain loop compared to European manufacturers.
Absolutely. We provide comprehensive OEM private label programs, including customized primary peelable pouches, multi-language Instructions for Use (IFU in Vietnamese and English), custom barcode/GS1 DataMatrix printing, and outer export master cartons built to withstand tropical maritime transport.
Our sterilization cycles are fully validated in accordance with ISO 11135 norms using biological indicators (Bacillus atrophaeus) and chemical indicators on every pouch. Post-sterilization degassing ensures Ethylene Oxide (EO) and Ethylene Chlorohydrin (ECH) residuals remain well below the strict limits mandated by international medical standards.
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