China NMPA legacy archive 国械注准20243141788Collagen patch dressing
- Device class
- Class III
- Model specifications
- 圆形:φ5cm、φ10cm、φ15cm、φ21.5cm、φ25cm、φ30cm;椭圆形:φ5cm×3cm、φ9.5cm×6cm、φ15cm×10cm、φ20cm×15cm、φ25cm×15cm、φ25cm×20cm、φ30cm×20cm;方形 :10cm×5cm、10cm×10cm、20cm×10cm、40cm×30cm、 40cm×10cm、 60cm×40cm.
- Approval department
- State Drug Administration
- Registration number
- 国械注准20243141788
- Approval date
- September 19, 2024
- Expiry date
- September 18, 2029
- Province/Region
- Shandong
- Address
- South of Fanlou Road, Shanxian Development Zone
- Production address
- 山东单县经济技术开发区食品药品产业园单德路6号
The product is suitable for the adjuvant treatment of wound repair after laser and photon surgery. The depth of the wound is limited to the superficial epidermis and dermis.
该产品适用于激光、光子术后创面修复辅助治疗。创面深度限于表皮及真皮浅层。
It is composed of type I collagen (0.1%~0.2%), purified water (99.95%~99.7%), potassium sorbate (0.05%~0.1%) and non-woven fabric. The sterilization method of the product is electron beam irradiation sterilization.
由I型胶原蛋白（0.1%~0.2%）、纯化水（99.95%~99.7%）、山梨酸钾（0.05%~0.1%）和无纺布组成。产品灭菌方式为电子束辐照灭菌。
- Appendix
- 产品技术要求
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