DEVICE DETAILS
| NAME OF DEVICE | Medical Surgical Incisive Dressing |
|---|---|
| ESTABLISHMENT NAME | ARTHOWORLD SDN BHD |
| ROLE OF ESTABLISHMENT | AUTHORIZED REPRESENTATIVE |
| REGISTRATION NO | GA6715424-179685 |
| BRAND NAME | Huawei |
| MEDICAL DEVICE CATEGORY | SINGLE-USE DEVICES |
| DEVICE GROUPING TYPE | FAMILY |
| DEVICE DESCRIPTION | Medical surgical incisive dressing has hypoallergenic characteristic for reduce the rate of sensitization to prevent infection. It has good viscous for good adhesion, high-quality medical pressure-sensitive adhesion makes an good using effect without warped edge, no residue, no pain when you tear off, can be tightly retained for long time on skin. It is highly breathable polyurethane film transparent and breathable to prevent moisture accumulation under surgery, provide a sterile working environment around the surgical incision. It has iodine concentration of surgical iodine drape 0.45%-0.8%, effectively kill variety of bacteria, sterilization rate reach 99%. Easy-pull bars on the both sides are available according to customers' requirement, or leave empty side (no glue) to tear off easier. It can also be used as the cut film with non-woven surgical drapes for compounding use, multiple sizes available. |
| DEVICE INTENDED PURPOSE | Medical surgical incisive dressing film from Wuhan Huawei Technology Co., Ltd. is divide into PU surgical film, PE surgical film, PU surgical iodine film, PE surgical iodine film. It adopts the high permeable polyurethane film (PU) or polyethylene (PE) as raw material, coated with a special medical pressure sensitive adhesive (iodine available), and then attached to release protective paper, protect the surgical area avoid cross-infection. |
| VALIDITY DATE OF REGISTRATION | 17/08/2024 - 16/08/2029 |