DEVICE DETAILS
| NAME OF DEVICE | POLY NUCLEOTIDE |
|---|---|
| ESTABLISHMENT NAME | ELOGIO ASIA PACIFIC SDN BHD |
| ROLE OF ESTABLISHMENT | AUTHORIZED REPRESENTATIVE |
| REGISTRATION NO | GD4704821-63820 |
| BRAND NAME | REJURAN |
| MEDICAL DEVICE CATEGORY | MD 0102 - Non-active devices for injection, infusion, transfusion and dialysis |
| DEVICE GROUPING TYPE | FAMILY |
| DEVICE DESCRIPTION | The REJURAN, REJURAN I & REJURAN S are members of REJURAN Product family. These are injectable gel for intradermal implants, consisting of highly purified Sodium Polynucleotides (20mg/mL concentration).It is presented in a pre-filled syringe with over 1.0 mL of PN solution, for single use only. One sterile needle is provided with syringe. |
| DEVICE INTENDED PURPOSE | Rejuran, Rejuran i and Rejuran s are the injectable gel which are intended for injection into the mid to deep dermis to promote tissue restoration and reconstruction, and improvement of physical appearance. It is highly versatile and easy to handle and can be used on areas of the skin: face (especially around the eyes, perioral area), neck, Décolleté, hands, and other areas. Only physician is allowed to use these medical device. It is prohibited to child, adolescent, pregnant, and lactating women. |
| VALIDITY DATE OF REGISTRATION | 15/06/2026 - 14/06/2031 |