🏭Company Profile
Established in 2005, our manufacturing facility specializes in disposable sterile medical consumables and related single-use devices. We focus on consistent quality, scalable production, and reliable delivery for global OEM/ODM customers. Our site covers approximately 32,000 m² with a built-up area of over 60,000 m². We operate more than 12,000 m² of ISO Class 8 (Class 100,000 equivalent) cleanroom facilities. Sterilization is supported by 8 EO sterilization cabinets. For quality assurance, we run an in-house testing center (approx. 800 m²) capable of biological, chemical, and physical testing, and we continuously invest in automation and inspection capabilities with 160+ sets of production equipment and 70+ sets of testing/QC equipment.
Our product portfolio is structured into five major series to serve different application scenarios and customer channels:
- (1) Medical Consumables: sterile syringes (with needles), sterile hypodermic needles, sterile infusion sets, insulin syringes and other basic single-use items.
- (2) Medical Aesthetic: medical aesthetic consumables and supporting disposables.
- (3) Veterinary (Animal Health): single-use consumables and medication administration accessories for pets and veterinary use.
- (4) Dental: dental consumables and supporting components.
- (5) Tattoo & Piercing: including Tattoo Needle Cartridges, tattoo needles and Body Piercing Needles.
In terms of capacity, our annual output of syringes exceeds 1 billion pieces, infusion sets reach around 100 million pieces annually, hypodermic needles can reach up to 2 million pieces per day, and surgical masks up to 1 million pieces per day. This capacity enables us to support multi-SKU, multi-batch purchasing plans with reliable lead times.
Quality and compliance are core to our operations. We operate an ISO 13485 certified quality management system, hold an EU MDR (EU) 2017/745 QMS certificate (TUV Rheinland, NB 0197) for listed product groups, maintain FDA establishment registration/device listing, and have a 510(k) clearance for specific syringe and hypodermic needle product families. We support customers with market-specific documentation based on the product scope and destination requirements.
OEM/ODM cooperation is available, including customized configurations, private labeling, artwork/printing support, multi-language labels and IFU, and export-ready packing options (such as PE pouch or blister packaging), carton quantity planning, shipping marks, and palletization suggestions. We work closely with customers on sampling, specification confirmation, packaging mock-up, mass production scheduling, and shipment arrangement. With ongoing investment in manufacturing and quality assurance, we are committed to being a long-term, reliable supply partner for distributors, brand owners, and medical device companies worldwide.
DrSharpe Health
