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Tru-Cut Biopsy Needle

Medical grade SUS304 stainless steel spring-triggered design, accurate cutting force up to 0.1mm, to ensure sampling integrity and cell activity. The whole series of products are sterilised by EO, suitable for 14G-20G multi-specification needles, and the negative pressure adsorption technology in the side groove, which can quickly obtain a sufficient amount of samples in 0.3 seconds. The tip of the needle is double bevelled and mirror polished, together with the anti-tissue adhesion coating, significantly reduces puncture resistance and artefact interference.

Triple independent epoxy sealing film packaging, through the ISO13485 and CE certification, suitable for ultrasound / CT image guidance equipment, suitable for tumour biopsy, liver puncture and other scenarios, to help accurate diagnosis, to protect the two-way safety of doctors and patients.

Zhejiang INI Medical Devices Co., Ltd.
Zhejiang INI Medical Devices Co., Ltd.

Zhejiang INI Medical Devices Co., Ltd., founded in 1987, is a state-certified manufacturer specializing in sterile medical devices, including disposable insulin syringes. Between 2009 and 2019, to meet growing market demand, the company significantly expanded its operations by investing over RMB 100 million in a new facility within Wenzhou Yongqiang High-tech Park. The site spans a total construction area of approximately 26,000 m², which includes an 8,000 m² 100,000-class clean workshop.
Our manufacturing infrastructure is tailored to the scale and requirements of medical device production. It features advanced equipment, spacious production and storage areas, and a controlled cleanroom environment. We uphold a rigorous quality management system, enforcing strict control over every production step. This is supported by a fully equipped and qualified inspection department with comprehensive testing capabilities appropriate for our production scale.
The company has established a quality assurance system in accordance with YY/T 0287-2017 / ISO 13485:2016, achieving certification through the internationally recognized TUV agency. This certification grants us the CE mark, affirming compliance with European Community standards.
Committed to continuous innovation and improvement, we strive to exceed regulatory and customer expectations. Our goal is to be recognized as a leading manufacturer with a strong corporate image and brand reputation. We sincerely welcome partnerships with domestic and international medical institutions to jointly contribute to the cause of global health.

Certificate of Honor
  • CE Certificate - DD 60149424 0001
  • Medical Device Product Export Sales Certificate
  • Medical Device Export Sales Certificate
  • Medical Device Export Sales Certificate
  • Medical Device Export Sales Certificate
  • Medical Device Export Sales Certificate
  • SX 2081180
  • Made in Zhejiang Certificate
  • Wenzhou Industry Association Certification
  • High and New Enterprise Certificate 2022
  • Level 2A Certificate
  • Honours
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In the domain of interventional diagnostics, a Tru-Cut Biopsy Needle is a highly precise instrument used by clinicians to extract core tissue samples under imaging guidance. INI as one of the Biopsy Needle Suppliers, we design, manufacture, and deliver Disposable Biopsy Needle products to medical device partners, hospitals, and clinical labs.

1. What is a Tru-Cut Biopsy Needle?

A Tru-Cut Biopsy Needle is a type of core biopsy instrument, often incorporating a cutting cannula and a stylet, which allows retrieval of a small cylindrical core of tissue. It is commonly used in soft tissue sites (such as breast, liver, kidney, lymph node) under guidance (e.g. ultrasound or CT). The device typically includes a specimen notch on the cutting cannula, depth markings, and a removable stylet for multiple insertions. The design aims to allow clinicians to obtain intact core samples with controlled mechanical action.

2. What distinguishes a Disposable Biopsy Needle in your offerings?

As a manufacturer, we produce Disposable Biopsy Needle units intended for single use. Because they are pre-sterilized and individually packaged, they reduce cross-contamination risk and simplify workflow in clinical settings. Our disposable models remove the need for reprocessing and align with standard medical device practices. Every unit is quality tested, sterilized, and sealed to preserve sterility until use.

3. What types of specifications can your manufacturing support?

As Biopsy Needle Suppliers, we offer a broad portfolio of Tru-Cut Biopsy Needle variants, including:

  • Gauges: common sizes such as 14G, 16G, 18G, 20G, depending on sample size needs
  • Lengths: varying shaft lengths to reach target sites
  • Specimen notch lengths: standard notches (e.g. ~20 mm) to hold tissue cores
  • Depth markings: centimeter gradations to assist placement
  • Removable stylet vs fixed stylet designs
  • Color-coded hubs or Luer-compatible connectors for system integration
  • Material finishes: mirror-polished cannulas, thin-walled designs to maximize inner diameter

We also offer optional customizations (OEM/ODM) for clients who need proprietary hub geometry, packaging, or branding.

4. What is the typical manufacturing process flow?

From a factory's perspective, producing a high-quality Tru-Cut Biopsy Needle or Disposable Biopsy Needle involves the following key steps:

  • Raw material control: We source medical-grade stainless steel tubing, verifying chemical composition and mechanical properties.
  • Tube processing: The tubing is drawn, annealed, straightened, and cut to preliminary length.
  • Cannula and stylet fabrication: The outer cannula is ground to form the cutting edge and specimen notch; the inner stylet is shaped to fit precisely with minimal play.
  • Surface finishing: Electropolishing or mechanical polishing minimizes burrs and surface roughness.
  • Hub machining and bonding: The cannula and stylet assemble into polymer hubs or connectors via ultrasonic welding or adhesive bonding.
  • Cleaning and drying: All components undergo cleaning (to remove residues), followed by controlled drying in clean environments.
  • Assembly and inspection: The inner and outer components are assembled; detailed dimensional checks, alignment tests, and visual inspections are performed.
  • Sterilization and packaging: Each Disposable Biopsy Needle is placed into a sterile pouch and sterilized (e.g. via ethylene oxide or gamma irradiation) under validated conditions.
  • Batch release testing: We perform leakage tests, integrity checks, and sterility checks before final release.

5. As a clinic or device integrator, what questions might you ask?

Here are some common questions from clients and how we answer them, in our role as Biopsy Needle Suppliers:

Q: How do you ensure consistent core sample length?

A: We precisely machine the specimen notch length and control cannula tolerances. Our inspection systems measure the notch and verify fit between cannula and stylet to yield consistent core capture length.

Q: Can you reduce trauma or deformation of the sample?

A: Our Tru-Cut Biopsy Needle designs include sharp scalpel-like edges and smooth internal surfaces, minimizing drag or tearing during tissue capture.

Q: How is sterility assured in disposable models?

A: Each Disposable Biopsy Needle unit is individually sealed and sterilized using validated sterilization processes. We maintain complete traceability of each lot.

Q: Can you support custom designs?

A: Yes. As Biopsy Needle Suppliers, we provide OEM/ODM service. If you need a special hub, connector, or marking scheme, we can adapt tooling and production to your requirements.