OEM/ODM
OEM & ODM Service for Medical Consumables
From concept to mass production — we customize non‑woven products, gauze products and surgical packs with your branding, packaging and compliance requirements.
What We Customize
End‑to‑end customization to match your market, regulatory and procurement needs.
Branding & Packaging
Logo printing, color scheme, IFU, barcode/UDI, retail or bulk packs.
Materials
SMS/PP/PE film, absorbent gauze, adhesive drapes, reinforced areas.
Specifications
Size, weight (gsm), absorbency, tie/knit cuffs, fenestration shapes.
Sterilization
EO or Gamma; validated SAL with full dossiers.
Components
Kit composition per procedure (e.g., angiography, C‑section, ENT).
Compliance Docs
COA, MSDS, biocompatibility, lot traceability, test reports.
OEM Process
Clear milestones keep your project on time and fully compliant.
* Lead time varies by kit complexity and sterilization.
Manufacturing Capabilities
MOQ & Lead Time
| Category | Typical MOQ | Sampling | Mass Production |
|---|---|---|---|
| Non‑woven Wear (gowns, caps, shoe covers) | 5,000–10,000 pcs | 7–10 days | 15–25 days |
| Gauze Series (pads, rolls, swabs) | 20,000–50,000 pcs | 7–10 days | 20–30 days |
| Surgical Packs & Drapes | 1,000–3,000 sets | 10–14 days | 25–40 days |
| Sterile Kits (EO/Gamma) | As per dossier | 10–21 days | 30–45 days |
Numbers are indicative; final schedule depends on configuration and regulatory needs.
Quality & Compliance
QMS
- ISO 13485 production system
- Lot tracking & CAPA
- Vendor audits
Testing
- Biocompatibility & cytotoxicity
- Fluid resistance / linting
- Sterility/SAL validation
Documents
- COA, MSDS, IFU
- CE technical file support
- Customs & shipping docs
Applications
Surgical Packs
General, C‑section, ophthalmic, plastic, ENT, upper‑extremity, angiography.
Non‑woven Wear
Surgical gowns, isolation gowns, caps, shoe covers.
Gauze & Dressings
Pads, rolls, swabs, bandages, dressing change kits.