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Industry Knowledge
Jiangsu Zhiyu Medical Instrument Co., Ltd. is a manufacturing-oriented Products manufacturer based in Taixing, Jiangsu, China. Since 2005 we have built our output around disposable medical consumables, and we now supply selected related lines for dental, aesthetic, tattoo and veterinary channels.
Our range covers injection, infusion, needle, protective, dental irrigation, respiratory care, microneedling and pet dosing products. Distributors, brand owners, hospital groups and OEM/ODM partners come to us for specification matching, packaging adaptation and repeatable batch supply rather than a single catalogue item.
Our Product Range and Where Each Line Fits
We organise the portfolio into five supply families so that a project can be configured from one manufacturing base. Each family carries its own specification logic, packaging conventions and regulatory scope, and we confirm the applicable documents against the exact product and target market before quotation.
| Supply Family | Typical Products | Application Fit |
|---|---|---|
| Medical Consumables | Syringes, insulin syringes, needles, IV products, infusion sets, protective items | Hospitals, clinics, immunisation programmes, pharmacy and distribution channels |
| Dental Consumables | Irrigation and injection devices for oral treatment workflows | Dental clinics, oral surgery, hygiene and chairside supply programmes |
| Healthcare Devices | Nebulizers, oxygen concentrators, suction machines | Respiratory care, oxygen therapy, airway clearance, home and clinical use |
| Medical Aesthetic Consumables | Aesthetic needles and cannulas, microneedling and tattoo products | Skin management, mesotherapy, microneedling, PMU and tattoo studios |
| Pet Consumables | Veterinary syringes, dosing devices and assisted nursing items | Veterinary clinics, animal hospitals, pet care retail and distribution |
Medical Consumables: Injection, Infusion and Needle Platforms
This is our core manufacturing family and the base of our capacity. The Disposable Syringes line covers standard sterile syringes, auto-disable models, safety syringes, oral and feeding syringes, and irrigation syringes, so a single procurement entry can serve routine injection, immunisation, oral dosing and flushing care.
- Volume range: common standard sizes from 5 mL to 30 mL; oral and feeding formats from 1 mL to 50 mL.
- Interface: Luer Slip and Luer Lock, with fixed-needle or needle-compatible configurations.
- Safety logic: auto-disable failure mechanisms for immunisation programmes, shielding or permanently attached needle designs for needlestick protection.
- Scale readability: clear graduation printing for accurate volume reading in clinical and home settings.
Insulin delivery is handled as a precision sub-family. Our OEM/ODM Insulin Syringes Factory in China line is built around small volumes, unit-based graduations and short fine needles, with 0.3 mL, 0.5 mL and 1 mL formats corresponding to U-100 unit markings and fixed needles in the 27G–31G band with short lengths for subcutaneous use.
Needle and infusion supply runs alongside the syringe lines: hypodermic needles, intravenous butterfly needles, safety needles, infusion sets and flush or irrigation syringes. Needle gauge, length, hub geometry, tubing length, drip chamber type and connector format are the variables we confirm per market.
Dental, Aesthetic and Veterinary Lines
These families reuse our injection-moulding, assembly and sterile packaging base while serving different end users. Dental supply centres on irrigation and injection devices that fit chairside treatment sequences. Aesthetic supply covers needles, cannulas, microneedling and tattoo products for skin management, mesotherapy and PMU studios. Veterinary supply covers syringes and dosing devices sized for animal handling and clinic workflows.
Because these channels often carry private brands, packaging adaptation matters as much as the device itself. We support neutral packaging, colour box, blister and PE bag options, multilingual labels and private-label artwork coordination.
Manufacturing Base and Capacity Configuration
Our production system links injection moulding, assembly, testing and packaging on the same lines, supported by automated equipment and online inspection. The published capacity figures for our syringe lines are 1 billion+ units per year, 160+ production equipment units, a 12,000+ m² purification room and a 32,000 m² site area.
- Clean production: controlled cleanroom manufacturing with EO sterilisation for sterile single-use items.
- Material control: medical-grade raw materials with incoming material inspection.
- Consistency: automated equipment, online monitoring and standardised process control across batch manufacturing.
- Inspection: in-process and final product inspection, retained samples and archived inspection records.
Quality Assurance and Regulatory Documentation
We operate a medical-device quality management system and hold documentation for applicable product lines, including ISO 13485:2016, EU MDR certification under Regulation (EU) 2017/745, FDA 510(k) clearance K212857, FDA facility registration and device listing, RoHS verification and a First Class Medical Device Production Filing Certificate. Regulatory scope differs by product, so we confirm which documents apply to the exact item and destination market during project evaluation.
Retained samples are kept through shelf life plus an additional two years according to internal procedures. For applicable products, automatic vision inspection and online monitoring at key stages strengthen batch consistency.
OEM/ODM and Customisation Support
Beyond standard supply, we take on project-based cooperation covering product matching and assortment planning, specification confirmation and extension, packaging adaptation and development, private-label support, mould development for applicable projects, structural optimisation and customised product development.
Projects move from concept to sampling, validation and volume production with coordination at each stage. Mould development, structural changes or proprietary packaging add time to the schedule, so early confirmation of key specifications keeps production planning accurate.
Information We Use to Configure Your Solution
A precise proposal depends on the working point, not on a category name. We use the following inputs to select models, plan packaging and estimate scheduling.
| Project Input | What It Determines |
|---|---|
| Product name and application scenario | Which supply family and model platform applies |
| Volume, size or dimensions | Barrel capacity, graduation system and unit markings |
| Needle type, gauge and length | Needle configuration, hub geometry and injection comfort |
| With or without needle; interface type | Luer Slip or Luer Lock, fixed or compatible needle |
| Packaging and private-label requirements | Blister, PE bag, colour box, neutral pack, multilingual labels |
| Target market and registration needs | Which regulatory documents apply to the item |
| Estimated order quantity and delivery schedule | Batch planning, tooling use and production sequencing |
| Drawings, photos or reference samples | Structural optimisation and custom development evaluation |
Standard products can usually be sampled from existing specifications. For customised projects, confirming the application scenario, specification requirements, packaging method and target market first allows us to prepare more suitable samples or trial solutions. Sample freight is normally borne by the customer.
Delivery, Documentation and Long-Term Supply
Lead time depends on product type, order quantity, specification complexity, packaging requirements and whether customisation is involved, so scheduling is handled case by case. Standard items are planned after order confirmation and related arrangements are settled.
We supply quality-related documents for registration, tender and distributor review where applicable, and coordinate packaging and labelling to match the destination market. Repeat orders follow the same confirmed specification and packaging record to keep continuity across shipments.
Frequently Asked Questions
What does Zhiyu manufacture?
We manufacture disposable medical consumables, including syringes, insulin syringes, auto-disable and safety syringes, hypodermic and butterfly needles, infusion sets and protective products. We also supply dental irrigation and injection devices, healthcare devices such as nebulizers, oxygen concentrators and suction machines, aesthetic and tattoo consumables, and veterinary consumables.
Do you support OEM and ODM projects?
Yes. We support product matching and assortment planning, specification confirmation and extension, packaging adaptation and development, private-label supply, mould development for applicable projects, structural optimisation and customised product development. Projects are coordinated from sampling and validation through to volume production.
Which quality and regulatory documents apply to my product?
Documentation is scoped per product line and market. Our current files include ISO 13485:2016, EU MDR certification under Regulation (EU) 2017/745, FDA 510(k) clearance K212857, FDA facility registration and device listing, RoHS verification and a First Class Medical Device Production Filing Certificate. We confirm the applicable set once the exact item and destination market are defined.
How is quality controlled during batch production?
Production runs under cleanroom conditions with medical-grade raw materials and EO sterilisation for sterile items. Incoming material inspection, in-process inspection and final product inspection are carried out, supported by automated equipment, online monitoring and automatic vision inspection on applicable products. Inspection records and quality reports are archived, and retained samples are kept through shelf life plus two years.
Can I order samples before committing to a volume order?
Yes. Standard products can usually be sampled from existing specifications. For customised projects, we ask for the application scenario, specification requirements, packaging method and target market first so that the sample or trial solution matches the intended use. Sample freight is normally borne by the customer.
What information should accompany a quotation request?
Product name, size or dimensions, needle type and gauge, with or without needle, packaging requirements, target market, estimated order quantity, whether OEM or private label is needed, and any drawings, photos or reference samples. For customised work, early clarification of the application scenario and key technical requirements speeds up development and production evaluation.
