Additional information
| Regulatory Compliance | MDD 93/42/EEC (Class Is / IIb), MDR 2017/745 (Transiting) |
|---|---|
| Manufacturing Unit | Fully Compliant integrated under ISO 13485:2016 QMS |
| Product Classification | Class IIb as per Annex VIII, Chapter III Rule 9 |
| Biocompatibility | Tested and compliant with ISO 10993 series standards |
| Primary Material | Medical Grade AISI 410/420 Stainless Steel |
| Insulation | Validated Medical Grade Polymers |
| Surface Finish | Polished passivated, corrosion resistance |
| Safety Compliance | REACH and RoHS compliant |
| Manufacturing Environment | Assembled and packed in controlled environment |
| Reprocessing Status | Not Applicable, it is a Single Use Product |
| Reprocessing Method | Validated Steam Autoclave (121°C – 135°C, 3–5 min Holding Time) |
| Sterilization Method | Ethylene Oxide (EtO) Sterilization Processed |
| EMDN Code | K020101 |
| Packaging Unit | Individually packed (1 piece per unit) / 20 units per box |
| Minimum Order Quantity | 20 Pieces / 01 Box |
| Manufacturer | Electro Range MFG Co. – ERMC® |
