A hospital supply manager in Colombo told me she'd spent two procurement cycles paying a Sri Lankan distributor the Terumo Surflo price — USD 0.55 per cannula — while her tender specification said only 'ISO 13485 certified, CE marked, EO sterile.' Nothing in the spec required a Japanese logo on the wrapper. The first time she asked for an alternative source quote from India, the FOB price came back at USD 0.10. The spec was identical. The iv cannula exporter from India just hadn't been on her approved vendor list yet.
B.Braun, BD, and Terumo are the formulary defaults in European and GCC hospital tenders — but their distributor pricing lands 4–8× above an ISO 13485, CE-marked Indian source. Manshav Impex exports 14G–24G IV cannulas at FOB USD 0.08–0.14 per piece with full CE DoC, ISO 13485 scope certificate, and 48-hour document turnaround.
India manufactures over 2 billion IV cannulas annually, primarily in Gujarat and Himachal Pradesh. The product falls under HS code 9018.39 (needles, catheters, and cannulas for medical use) and must meet ISO 10555-1 (intravascular catheters — general requirements) for export to regulated markets. The supply base breaks into two practical tiers: large listed Indian companies (Polymed, HMD, Medisel) targeting institutional tenders, and factory-direct exporters like Manshav Impex that serve distributors, regional wholesalers, and private hospital chains looking for full-documentation access without an intermediary layer.
What most buyers outside India don't realise is that the ISO 13485 and CE mark requirements for IV cannulas are specification requirements — not brand requirements. A CE-marked IV cannula from a Surat factory that has passed ISO 10555-1 testing at an ISO 17025 accredited lab meets the identical technical requirement as a B.Braun Introcan or BD Venflon. The difference is brand recognition, distributor network, and — the one that matters most for a procurement budget — price.
A distributor in Kenya switched from a European-brand IV cannula to an ISO 13485, CE-marked Indian source and cut per-unit cost by 62% — with no nursing complaints about needle sharpness or flash-back chamber visibility at a 6-month review.
ISO 13485, CE DoC, ISO 10555-1 test data, and 48-hour document turnaround. IV cannulas & infusion sets · Full catalogue · Request quote · WhatsApp +91 84601 91818 · info@manshavimpex.com
| Factor | Detail |
|---|---|
| Product range | 14G – 24G; ported and non-ported; with/without wings; Y-port ported options |
| Sterilisation | EO-sterilised (ethylene oxide), individually blister-packed |
| Standards | ISO 10555-1 (intravascular catheters), ISO 13485 (QMS) |
| Certifications | CE-marked, ISO 13485, WHO-GMP compliant manufacturing practices |
| MOQ (export) | 3,000 pcs per size (mixed-size FCL negotiable for pilot orders) |
| Lead time | 3–4 weeks FOB Nhava Sheva / Mundra |
| Dossier support | CE DoC, ISO 13485 scope cert, ISO 10555-1 test report, CoA per batch, CFS, EO sterilisation validation summary |
| HS Code | 9018.39 |
| Incoterms | FOB / CIF / CFR; DDP available for select corridors |
| Private label | Yes — custom print on pouch and outer box; 6–8 week tooling for new label |
B.Braun Introcan Safety (Melsungen, Germany) is the dominant European reference brand for IV cannulas in hospital tenders across Africa, the GCC, and Southeast Asia. Its BIOSAFE coating and passive safety mechanism are genuinely differentiated features for EU MDR environments where needlestick injury logs are audited. The Introcan range covers 14G–26G and carries a strong regulatory paper trail. What it does not offer to a Nairobi or Lagos distributor is factory-direct access, a flexible MOQ, or a non-safety version at emerging-market pricing. Distributor landed prices for standard Introcan in East Africa run USD 0.45–0.65 per piece.
BD Venflon (Becton Dickinson, Franklin Lakes, New Jersey) is the other globally specified IV cannula brand — its Venflon Pro range is the default for NHS procurement and widely referenced in GCC tenders. BD's regulatory documentation is impeccable and its flash-back chamber visibility is consistently noted as a clinical differentiator by anaesthetists. BD does not export direct to distributors; access is through BD's own regional distribution network. In East Africa and South Asia, Venflon lands at USD 0.40–0.60 per piece through authorised distributors, with no direct factory-dossier access for importers registering the product independently.
Terumo Surflo (Terumo Corporation, Tokyo) is the preferred brand in South and Southeast Asia — high build quality, PTFE-coated needle bevel, colour-coded hub, and a strong safety data record. Terumo operates through tight regional distributors and does not offer OEM or private-label programmes. For buyers in Sri Lanka, Bangladesh, or the Philippines who want their own registered brand on the product, Terumo is simply not an option. Distributor prices in South Asia: USD 0.35–0.55 per piece.
Is there a clinical performance gap? For standard peripheral IV access in adult general wards — which accounts for the vast majority of cannula volume in any hospital — the honest answer is no detectable difference where the test data matches. The PTFE coating, bevel geometry, and flash-back chamber on a well-manufactured Indian CE-marked cannula perform identically to a European or Japanese equivalent at the same gauge. Here's what most exporters won't tell you: the ISO 13485 certification path and the CE test data have already been completed by every serious Indian manufacturer — buyers paying 5× the Indian price are paying for legacy, not performance.
| Dimension | Manshav Impex | B.Braun Introcan | BD Venflon | Terumo Surflo |
|---|---|---|---|---|
| Base | Surat, Gujarat, India | Melsungen, Germany | Franklin Lakes, USA | Tokyo, Japan |
| Gauge range | 14G – 24G | 14G – 26G (Safety range) | 14G – 26G (Venflon Pro) | 14G – 24G |
| Safety mechanism | Standard; passive safety version on request | Passive safety (BIOSAFE) | Passive safety (Venflon Pro Safety) | Standard + ViaValve safety range |
| CE mark / ISO 13485 | Yes — direct factory CE DoC + ISO 13485 cert | Yes — EU MDR transition advanced | Yes | Yes |
| ISO 10555-1 test report | Yes — ISO 17025 accredited lab | Yes | Yes | Yes |
| WHO-GMP | Compliant manufacturing practices | EU GMP equivalent | US FDA 21 CFR 820 | PMDA Japan equivalent |
| MOQ (new account) | 3,000 pcs per size; pilot qty negotiable | Via distributor — high minimums | Via BD network — high minimums | Via distributor — high minimums |
| Dossier access (PPB/NAFDAC/DGDA) | Direct factory — 48 h turnaround | Distributor-managed — slow on queries | BD regional office — slow | Distributor-managed — slow |
| FOB price indicative 20G per piece | USD 0.09 – 0.12 | USD 0.25 – 0.45 (distributor, not FOB) | USD 0.22 – 0.40 (distributor, not FOB) | USD 0.18 – 0.35 (distributor, not FOB) |
| Private label / OEM | Yes — full programme, 6–8 wk tooling | No direct OEM for export | No direct OEM for export | No direct OEM for export |
*B.Braun, BD, and Terumo figures are distributor-level landed-price estimates from procurement feedback across East Africa, GCC, and South Asia — not published list prices. FOB equivalents from those brands are not available through public channels; the comparison reflects realistic total acquisition cost for buyers outside the brands' primary distribution networks.*
| Gauge | Type | Indicative FOB per Piece | Pcs per 20ft FCL (approx.) |
|---|---|---|---|
| 14G (orange) | Non-ported, EO sterile | USD 0.13 – 0.16 | 900,000 – 1,100,000 |
| 16G (grey) | Non-ported, EO sterile | USD 0.11 – 0.14 | 900,000 – 1,100,000 |
| 18G (green) | Ported / non-ported, EO sterile | USD 0.09 – 0.12 | 1,000,000 – 1,200,000 |
| 20G (pink) | Ported / non-ported, EO sterile | USD 0.09 – 0.11 | 1,100,000 – 1,300,000 |
| 22G (blue) | Ported / non-ported, EO sterile | USD 0.08 – 0.10 | 1,200,000 – 1,400,000 |
| 24G (yellow) | Paediatric, ported, EO sterile | USD 0.08 – 0.10 | 1,200,000 – 1,400,000 |
Which specific ISO 10555-1 tests have been completed on this product? The standard covers dimensional requirements, flow rate, biocompatibility (ISO 10993 series), sterility, and freedom from particulate. A supplier citing 'ISO compliant' without a test report from an accredited lab is citing a label.
What is the coating specification on the needle bevel — and is it tested per ISO 10555-5? PTFE coating thickness affects insertion smoothness, especially in small-gauge paediatric sizes (24G, 26G). The test standard is ISO 10555-5 (lubricity of needle coatings by friction measurement). Ask for the test result, not just a claim.
Can the supplier produce lot-level CoAs within 48 hours of a regulatory query? In a live customs clearance or PPB inspection, a 72-hour document delay means missed delivery windows and demurrage at Mombasa or Lagos. Document turnaround is a supply-chain spec, not an administrative nicety — qualify it before you commit an annual contract.
What is the EO sterilisation validation status? An ISO 11135-validated EO cycle with biological indicator data is the minimum for an NAFDAC, PPB, or DGDA submission. Ask for the validation summary — is it product-specific to this exact gauge and tray count, or is it a category validation? A category validation that does not include the specific tray load you are ordering is a submission risk.
Manshav Impex exports 14G–24G IV cannulas at FOB USD 0.08–0.16 per piece — ISO 13485 certified, CE-marked, EO-sterile, with ISO 10555-1 test data, 48-hour document turnaround, and a private-label programme for distributors. B.Braun Introcan, BD Venflon, and Terumo Surflo are the formulary defaults when your tender specification was written by a European-trained procurement team, and their quality is real. But when does a hospital in Ghana or Bangladesh actually need a German logo on its IV line — and when is that logo simply the most expensive line in the consumables budget with no clinical return?
The minimum documentation stack for regulated-market import is: ISO 13485 scope certificate covering IV cannula manufacture, CE Declaration of Conformity (DoC) under MDD 93/42/EEC, ISO 10555-1 test report from an ISO 17025 accredited laboratory, Certificate of Analysis (CoA) per lot, EO sterilisation validation summary (ISO 11135), and Free Sale Certificate (CFS) issued by the Indian regulatory authority (CDSCO/State Drug Controller). For markets with specific device registration (NAFDAC Nigeria, PPB Kenya, DGDA Bangladesh, SFDA Saudi Arabia), the full technical file including labelling samples is additionally required.
Chinese IV cannula manufacturers (primarily in Shandong, Zhejiang, and Jiangsu) offer comparable or marginally lower FOB pricing — often USD 0.07–0.10 per piece for standard gauges. For buyers in regulated markets, the relevant comparison points are: (a) CE mark legitimacy — post-2021 scrutiny on Chinese CE certificates for medical devices is elevated; Indian CE documentation through European notified bodies carries lower challenge risk at regulatory submission; (b) transit time — Indian ports are typically 5–10 days faster to East African and GCC destinations than Chinese ports; (c) documentation access — a factory-direct Indian exporter can produce lot-level CoAs and validation summaries on request, where a Chinese trading intermediary often cannot.
Yes — Manshav can supply IV cannulas with a passive retractable safety sleeve on request. Safety versions are primarily relevant for EU MDR submissions (where EU Directive 2010/32/EU on sharps injury prevention is enforced) and NHS-equivalent procurement in the UK and GCC. For most tender submissions in Africa and South/Southeast Asia, standard non-safety CE-marked cannulas are accepted. Specify your regulatory requirement at the quotation stage — the choice between standard and safety affects FOB price by approximately USD 0.04–0.07 per piece.
Manshav's standard export MOQ is 3,000 pieces per gauge size. For new export accounts validating the product before committing to a full container, mixed-gauge pilot orders at lower total quantity are negotiable — the constraint is that a mixed-size shipment needs minimum 500 pieces per size to be cost-effective per-unit on inner carton packing. A standard 20ft FCL of IV cannulas carries approximately 1,000,000–1,400,000 pieces depending on gauge.
Yes. Manshav's OEM/private-label programme covers custom print on the individual blister pouch, inner carton, and outer box — including brand name, logo, barcode, and country-specific labelling requirements. Tooling for a new label design is 6–8 weeks; the regulatory package (CE DoC, CoA, CFS) is issued in Manshav's name as the manufacturer unless the buyer holds their own notified-body arrangement. MOQ for private-label runs is negotiable from 1×20ft FCL.
Indian IV cannula exporters ship DEHP-free, ISO 10555-1-compliant peripheral IV catheters in gauges 14G–26G at FOB USD 0.04–0.11 per unit — 55–75% below EU brand landed cost. MOQ 20,000 units per gauge, 14–21 days lead time, full CE and ISO 13485 documentation.
Polymed is a listed Indian manufacturer. Manshav Impex is factory-direct with 3,000-pc MOQ and 48-hour documents. Here's how hospital buyers should choose between them.
Hospitals and distributors importing disposable syringes from Europe or China pay 25–40% more than the factory-direct FOB price available from certified Indian manufacturers — with identical CE marking, ISO 13485 QMS, and full CDSCO export documentation on every order.