Reusable Suction Canister with Liner for Surgical Use — CE ISO 13485

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Reusable Suction Canister with Liner for Surgical Use — CE ISO 13485

Product Overview

The reusable suction canister with liner is the standard fluid waste management solution for surgical operating rooms worldwide. This system pairs a durable, autoclavable outer canister with a single-use disposable liner, delivering clinical safety and operational efficiency in high-frequency OR environments.

For medical distributors seeking consistent bulk sourcing with OEM/ODM flexibility, this reusable outer canister suction liner system offers direct factory pricing, custom branding, and volume-based lead times designed to fit regional distribution requirements.

Key Technical Specifications

ParameterDetail
Product NameMedical Reusable Suction Canister with Disposable Liner
Capacity Options1000 ml / 1500 ml / 2000 ml / 3000 ml (full series)
Canister MaterialPolycarbonate (PC) / ABS — medical grade, shatter-resistant
Liner MaterialMedical-grade Polyethylene (PE) — single-use disposable
Lid / SealThermoplastic, high-frequency fusion bond; withstands >= 60 kg compression
Hydrophobic FilterBacterial filtration efficiency > 99.85%; Viral filtration efficiency >= 97.5%
Solidifying AgentSuper Absorbent Polymer (SAP) — solidifies waste for compliant disposal
Valve TypeSilicone unidirectional valve — prevents liquid backflow into vacuum line
Safety DesignDouble anti-backflow system + mechanical shut-off valve
SterilizationEO Sterilization (liner); Autoclavable outer canister at 134 degrees C
CertificationsCE Mark + ISO 13485
Shelf Life2-3 years (EO-sterilized liner)

Key Benefits for Medical Distributors

  • CE + ISO 13485 dual certification meets hospital tender requirements in EU, MENA, and Asia-Pacific markets without additional distributor compliance steps.
  • Full capacity series (1000-3000 ml) under one supplier — reduces SKU complexity and simplifies distributor purchasing and logistics.

 

FAQ — Distributor Procurement

  • What certifications does this suction canister with liner hold, and are they valid for EU hospital tenders?

The product carries CE marking and ISO 13485 quality management certification. CE marking confirms conformity with EU Medical Device Regulation (MDR), making it directly eligible for EU public hospital tenders. ISO 13485 documentation is available upon request to support distributor qualification processes.

  • What is the minimum order quantity (MOQ) for bulk procurement, and what lead times can distributors expect?

Standard MOQ starts at 500 units per SKU. Lead times are typically 15-25 business days after order confirmation and artwork approval. For annual contract volumes, priority production slots and tiered pricing are available. OEM/ODM orders with custom packaging require an additional 5-7 business days for artwork review.

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