Suction Canister Liner System CE ISO 13485 — Wholesale & OEM Supply
Product Overview
The suction canister liner system with CE and ISO 13485 certification is among the most consistently demanded product families in medical device distribution portfolios worldwide. As hospitals transition from fully disposable suction canisters to reusable outer canister systems with single-use liners, distributors who offer a compliant, full-series CE ISO 13485 suction canister liner system are positioned to capture both replacement demand and new tender business.
This reusable outer canister suction liner system combines a polycarbonate outer container — autoclavable at 134 degrees C — with EO-sterilized disposable PE liners across a 1000 ml to 3000 ml capacity range. The hydrophobic filter, silicone unidirectional valve, and dual anti-backflow design meet fluid management and infection control specifications required under EU MDR, ISO 10079, and equivalent regional standards, reducing the regulatory burden for distributor market entry.
Key Technical Specifications
Parameter
Detail
Product Name
Medical Reusable Suction Canister with Disposable Liner
Capacity Options
1000 ml / 1500 ml / 2000 ml / 3000 ml (full series)
Canister Material
Polycarbonate (PC) / ABS — medical grade, shatter-resistant
Super Absorbent Polymer (SAP) — solidifies waste for compliant disposal
Valve Type
Silicone unidirectional valve — prevents liquid backflow into vacuum line
Safety Design
Double anti-backflow system + mechanical shut-off valve
Sterilization
EO Sterilization (liner); Autoclavable outer canister at 134 degrees C
Certifications
CE Mark + ISO 13485
Shelf Life
2-3 years (EO-sterilized liner)
Color / Marking
Transparent canister body with color-coded lid for fast identification
Clinical Applications
Surgical OR, ICU, Gynecology, Emergency Room, General Ward
Key Benefits for Medical Distributors
Wholesale bulk pricing with competitive MOQ (from 500 units per SKU) — direct factory supply eliminates intermediary markups and supports distributor margin targets.
Full 1000-3000 ml series available from a single supplier — simplifies purchasing, logistics, and SKU management for distributors covering multiple hospital departments.
OEM/ODM fully supported: custom logo, lid color, carton design, IFU translation — build proprietary product lines on a certified, proven manufacturing platform.
FAQ — Distributor Procurement
What makes this suction canister liner system competitive for hospital tender submissions?
Three factors determine tender award in this category: certification compliance, total cost of ownership (TCO), and supply reliability. This system provides CE + ISO 13485 certification (compliance), a reusable canister with disposable liner that cuts per-procedure cost by 40-60% versus fully disposable alternatives (TCO), and ISO 13485 QMS-controlled production with documented capacity for large-volume contracts (supply reliability).
Can you support OEM/ODM for a regional private-label suction product line?
Yes. OEM/ODM covers: canister body logo, lid color selection, outer carton design and print, IFU translation and localization (15+ languages available), and custom product codes. Existing tooling supports all standard sizes with no additional tooling cost. Private-label programs require a signed NDA and a minimum annual volume commitment. Pre-production samples are available for distributor approval before full production release.
