OEM & Private-Label Medical Device Manufacturing — CE & ISO 13485 Factory in China
HEZE YINUO MEDICAL is a direct manufacturer of disposable medical devices offering full OEM (Original Equipment Manufacturer) and ODM (Original Design Manufacturer) services — your brand, your packaging, your specifications. From a 32,000 m² ISO 13485-certified facility producing 300 million syringes and 100 million infusion sets per year, we help importers, distributors and private-label brands in 50+ countries bring CE-marked medical supplies to market.
What We Offer
OEM / private label. We manufacture to your brand: custom printed barcodes and logos on the device, blister and box artwork, multilingual labeling and inserts, and your regulatory registration holder details.
ODM / custom design. Need a non-standard size, gauge, connector, dose lock or configuration? Our R&D team develops tooling and validated specifications for your market.
Custom packaging. Unit pouches, inner boxes and master cartons designed to your requirements, including retail-ready and hospital bulk packaging.
Regulatory support. Full documentation packages (CE / EU MDR & IVDR, ISO 13485, Free Sales Certificate, technical files, sterilization and biocompatibility reports) for ANVISA, COFEPRIS, SFDA, NAFDAC, Kemenkes and other authorities.
Product Lines Available for OEM
We private-label our full catalog of 57+ disposable devices:
- Disposable syringes — 1–60 ml Luer Lock/Slip, auto-disable, safety, insulin, vaccine
- Hypodermic needles & IV cannulas, scalp vein sets, blood collection needles, safety lancets
- IV infusion sets — Luer Lock/Slip, Y-port, blood transfusion, 100/150 ml burette
- Oxygen & anesthesia — oxygen/nebulizer/laryngeal masks, ET tubes, breathing circuits
- Protective products — surgical & isolation gowns, FFP2 respirators, coveralls, face masks
- Catheters & tubes — Foley catheters, feeding/stomach tubes, suction catheters, surgical blades
The OEM Process
- Inquiry. Send us your product list, specifications, target market and any tender text to meet.
- Quotation. We reply within one working day with unit price, MOQ, lead time and applicable certifications.
- Sampling. Free product samples for evaluation (buyer covers shipping); 3–5 working days.
- Artwork & tooling. We prepare and confirm print artwork and, for ODM items, custom tooling.
- Production. 25–35 days for standard items, 35–45 days for OEM private-label orders.
- QC & shipping. In-line and pre-shipment inspection, certificate of analysis per batch, then FOB/CIF export.
MOQ & lead time. Standard OEM MOQ is 100,000 pieces per specification for non-printed orders and 500,000 pieces for custom-printed private label; lower MOQs are possible for trial orders. Payment: 30% T/T deposit, 70% against B/L copy; L/C at sight for orders over USD 30,000.
Frequently Asked Questions
What is the difference between OEM and ODM?
OEM means we manufacture an existing product to your brand and packaging. ODM means we also design or customize the product (size, connector, configuration) to your specification. We offer both.
What is the minimum order quantity for private label?
100,000 pieces per specification for non-printed goods and 500,000 pieces for custom-printed private label. Trial orders with lower quantities can be discussed.
Do you provide CE and ISO 13485 documentation for our registration?
Yes. We supply full regulatory documentation (CE under EU MDR/IVDR, ISO 13485:2016, Free Sales Certificate, technical file, sterilization and biocompatibility reports) to support registration with ANVISA, COFEPRIS, SFDA, NAFDAC, Kemenkes and other authorities.
Can you print our brand and design our packaging?
Yes — custom logo and barcode printing on the device, blister and box artwork, multilingual labels and inserts, and custom master-carton packaging.