sales@newmeen.com WhatsApp/WeChat: +8618101602894 ISO 13485 · CE · FDA registered

About Shanghai Newmeen Medical Co., Ltd.

A puncture instrument specialist serving hospital distributors, OEM brands and pharmaceutical packaging programmes in more than 40 markets.

About Newmeen

Focused on the point of puncture

Newmeen was built around one narrow competence: the geometry, sharpness and safety of a needle tip. Everything else — hubs, catheters, tubing, packaging — is designed around that interface.

Our manufacturing ecosystem covers cannula drawing, grinding and laser inspection, hub moulding, automated assembly, printing, EO sterilisation and cleanroom packaging. Because the process is in house, we can hold tolerances that trading companies cannot promise, and we can change a tip geometry without changing supplier.

We are a contributing drafter of China's national standards for medical needle cannulas, and we produce more than ten billion cannulas a year for clinical, aesthetic, veterinary and pharmaceutical packaging applications.

Manufacturing site
Cannulas / year10 billion
Finest cannula35G / 0.15 mm
Capability

What happens inside the plant

Six process stages, one quality system, one batch record.

Cannula forming

Stainless steel strip is drawn and cut to 0.15–2.1 mm outside diameter, then ground to the required bevel geometry.

Inspection

Optical and laser stations check tip geometry, lumen patency and burr-free edges; results are attached to the batch record.

Moulding & assembly

Hubs, wings, catheters and safety mechanisms are moulded and assembled in a controlled environment.

Sterilisation

Ethylene oxide cycles with validated parameters, biological indicators and residual limits below ISO 10993-7.

Packaging

Blister, peel pouch, pen sheath, bulk carton and private-label artwork with multilingual labelling.

Documentation

Batch COA, sterilisation certificate, technical file, declaration of conformity and free sale certificate.

Quality & registration

Certification you can file

Our quality management system is certified to ISO 13485 and audited annually. EU technical documentation is maintained under MDR, the US establishment is registered with the FDA, and free sale certificates are issued for importing countries on request.

ISO 13485

Quality management system

CE

EU MDR technical documentation

FDA

Establishment registration & device listing

FSC

Certificate of free sale

Team

Four functions, one account

Every customer works with a named export manager, backed directly by engineering, QA/RA and production planning — no layers in between.

EM
Export sales

English, French, Spanish and Russian quotations, samples and order follow-up.

QA
QA / RA

Registration dossiers, technical files, batch release and complaint handling.

RD
Engineering

Cannula geometry, tooling, first-article inspection and custom assemblies.

PP
Production planning

Capacity booking, release schedules and private-label artwork control.

How we work

From enquiry to container

A typical OEM programme runs in five steps. Standard catalogue items skip steps two and three.

Request a quote
  • 01
    Specification review

    Gauges, lengths, tip geometry, packaging and destination market — reviewed against our standard matrix.

  • 02
    Sample & validation

    Pre-production samples with dimensional report and, where required, biocompatibility documentation.

  • 03
    Tooling & first article

    Artwork, moulds or cannula geometry frozen after first-article inspection and customer approval.

  • 04
    Production & release

    Batch manufacturing, EO sterilisation, AQL inspection and batch certificate before packing.

  • 05
    Shipping & documents

    FOB, CIF or DDP with packing list, invoice, COA and certificates for customs clearance.

Add us to your approved supplier list

We can complete your supplier questionnaire, provide audit documentation and ship samples in the same week.

Contact us