Shenzhen Tenchy Silicone&Rubber Co.,Ltd
| Payment Terms | D/A, D/P, T/T, Western Union, MoneyGram |
| Supply Ability | 1000 pcs per day |
| Delivery Time | 5-8 days |
| Packaging Details | 10 pcs/box (Individually sterile sealed) |
| Brand Name | TENCHY |
| Model Number | TCM-002 |
| Certification | USP CLASS VI |
| Place of Origin | CHINA |
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Product Specification
| Payment Terms | D/A, D/P, T/T, Western Union, MoneyGram | Supply Ability | 1000 pcs per day |
| Delivery Time | 5-8 days | Packaging Details | 10 pcs/box (Individually sterile sealed) |
| Brand Name | TENCHY | Model Number | TCM-002 |
| Certification | USP CLASS VI | Place of Origin | CHINA |
| High Light | sterile triple-lumen silicone catheter ，hydrophilic coated silicone catheter ，medical silicone tube catheter | ||
I. Core Product Features & Description (Enhanced)
1. Premium Material - 100% Medical Grade Silicone: Excellent biocompatibility, exceeding ISO 10993 standards. Soft and comfortable for long-term indwelling, reducing tissue irritation and infection risk. High physicochemical stability.
2. Revolutionary Lubrication - Hydrophilic Polymer Coating: Activated instantly by water or saline, forming a low-friction hydrogel layer (friction reduction >90%). Enables virtually painless insertion and removal and provides lasting comfort during wear.
3. Sophisticated Design - Triple Lumen Structure:
· Drainage Lumen: For urine outflow.
· Balloon Inflation/Deflation Lumen: For filling/emptying the retention balloon with sterile water/saline.
· Irrigation/Aspiration Lumen: For bladder irrigation with fluids (e.g., saline), instillation of medication (e.g., antibiotics), aspiration of residual fluid, or sampling.
4. Safety Assurance - Pre-Sterilized Packaging: Sterilized using Ethylene Oxide (EO) for sterility assurance (SAL ≤ 10⁻⁶). Each catheter is individually sealed for immediate use upon opening.
5. Compliance & Versatility: Widely applicable in hospitals, clinics, surgery centers, rehabilitation, and long-term care facilities. Compliant with CE Mark (EU MDD/MDR), ISO 13485:2016, FDA regulations, and LFGB (material safety). Material passes relevant ISO 10993 biocompatibility tests.
6. Safety Features: Soft rounded tip design (often Coude/Straight), color-coded balloon zone for positioning, clearly labeled inflation valve.
| Category | Parameter Details |
| Basic Information | |
| Product Model | TCM-002 |
| Full Product Name | Disposable Super-Slippery Hydrophilic-Coated Sterile Triple-Lumen Silicone Catheter |
| Brand | TENCHY or OEM |
| Material | 100% Medical Grade Silicone |
| Catheter Size (French) | Fr 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 (Note: Verify balloon options for Fr8-12) |
| Catheter Working Length | 400 mm (40 cm) |
| Balloon Volume (ml) | Varies by Fr Size: |
| * 14Fr: 5ml / 5-10ml / 15ml | |
| * 16Fr: 5ml / 5-10ml / 20ml / 30ml | |
| * 18Fr: 5ml / 5-10ml / 20ml / 30ml | |
| * 20Fr: 10ml / 30ml | |
| * 22Fr: 10ml / 30ml | |
| * 24Fr: 10ml / 30ml | |
| * 26Fr: 10ml / 30ml | |
| Balloon Characteristics | Compliant design, Balloon Burst Pressure ≥ 5ATM (standard test). Only use sterile water/saline. Never use air. |
| Usage Attribute | Single Use Only |
| Product Type | Urological Catheter, Drainage Tube |
| Supply Capacity | 10,000 pcs / day |
| Minimum Order Quantity (MOQ) | 100 pcs |
| Delivery Time | 5-8 days |
| Payment Terms | L/C, T/T, Western Union, MoneyGram, PayPal |
| Packaging Details | |
| Inner Packing | 10 pcs/box (Individually sterile sealed) |
| Outer Packing (Options) | |
| * 20 boxes / carton = 200 pcs/carton (Volume: _ cm x _ cm x _ cm, GW ~ _ kg) Estimate | |
| * 40 boxes / carton = 400 pcs/carton (Volume: _ cm x _ cm x _ cm, GW ~ _ kg) Estimate | |
| * 50 boxes / carton = 500 pcs/carton (Volume: _ cm x _ cm x _ cm, GW ~ _ kg) Estimate | |
| * Customizable Packaging Supported | |
| Certification & Testing | |
| Quality Management System | ISO 13485:2016 Certified |
| Regulatory Approvals | CE Mark (Complies with EU MDD 93/42/EEC or MDR 2017/745, Class IIa/IIb) FDA Registered LFGB (Proof of material food safety compliance) |
| Biocompatibility Testing | Compliant with ISO 10993 series standards, Test reports available (upon request) including: |
| * Cytotoxicity - MTT Test, etc. * Sensitization * Irritation * Pyrogenicity (In-vivo/In-vitro) * Hemocompatibility - Hemolysis Test |
Company Details
Business Type:
Manufacturer
Year Established:
2008
Employee Number:
50~100
Ecer Certification：
Verified Supplier
EVERYTHING IN SILICONE Tenchy Silicone&Rubber Co.,Ltd specializes in silicone extrusion and molding products. Our current product line includes silicone sealing ring, silicone tubing, silicone reinforced hose, silicone molded parts, silicone gasket, silicone profile, silic... EVERYTHING IN SILICONE Tenchy Silicone&Rubber Co.,Ltd specializes in silicone extrusion and molding products. Our current product line includes silicone sealing ring, silicone tubing, silicone reinforced hose, silicone molded parts, silicone gasket, silicone profile, silic...
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